research paper about quality control

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• Published: 14 May 2021

Quality control of protein reagents for the improvement of research data reproducibility

• Ario de Marco 1 ,
• Nick Berrow   ORCID: orcid.org/0000-0002-6104-4117 2 ,
• Mario Lebendiker 3 ,
• Maria Garcia-Alai 4 ,
• Stefan H. Knauer   ORCID: orcid.org/0000-0002-4143-0694 5 ,
• Blanca Lopez-Mendez   ORCID: orcid.org/0000-0001-8541-4904 6 ,
• André Matagne 7 ,
• Annabel Parret   ORCID: orcid.org/0000-0003-0635-8890 4 ,
• Kim Remans 8 ,
• Stephan Uebel   ORCID: orcid.org/0000-0002-3726-3942 9 &
• Bertrand Raynal   ORCID: orcid.org/0000-0001-5634-0408 10  

Nature Communications volume  12 , Article number:  2795 ( 2021 ) Cite this article

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• Analytical biochemistry
• Molecular biophysics

Proteins and peptides are amongst the most widely used research reagents but often their quality is inadequate and can result in poor data reproducibility. Here we propose a simple set of guidelines that, when correctly applied to protein reagents should provide more reliable experimental data.

There have been several publications over the last decade highlighting the problems of irreproducibility in preclinical research over a wide range of scientific disciplines (see ref. 1 for a discussion of the many facets of this problem and ref. 2 for a collection of commentaries and analyses for different research sectors). Other reviews have attempted to quantify the economic cost dimension represented by data irreproducibility 3 , focusing on specific reagents widely used by the scientific research community such as antibodies 4 . These reports make uncomfortable reading for researchers, who by training are indeed aware that reproducibility is a critical issue that needs to be tackled 5 . The problem is openly acknowledged by both funding bodies 6 and journals 7 , 8 . Thus far, however, the issue appears to have been addressed on a field-by-field basis rather than through a community-wide effort.

Although purified proteins are used in numerous fields of research, no clear standard for the quality control (QC) of protein reagents currently exist and those that do exist are vastly under-utilized. These controls however should be deemed essential from a scientific point of view, to allow the identification of poor quality or artefactual research as early as possible to limit snowball effects; whereby a published paper can rapidly spawn a huge number of secondary papers and citations even when the original data are not reproducible. Although there have been many reports (see e.g., refs. 9 , 10 , 11 , 12 ) describing the effects of poor protein quality on the validity and reproducibility of experimental data, to date there has been little visible response to this specific problem from the research community.

The use of poor quality peptides, proteins and antibodies as experimental reagents impacts both the quality and cost of research carried out using these reagents. One estimate 3 puts a figure on the level of irreproducible preclinical experiments in the US (using 2012 data) at fifty percent, equating to a staggering economic cost of $28 billion per annum in the US alone, of which thirtysix percent ($10.4 billion worth of research) was directly attributed to poor quality ‘biological reagents and reference materials’. At present we are aware of only very few journals where there is a requirement for authors to include QC data for the proteins used as ‘reagents’ in their studies. This situation appears to be in direct contrast to e.g., the high standards of statistical analyses and declarations of statistical compliance required in articles submitted to high-end journals when presenting genomic, proteomic and structural data 13 . With the aim of addressing this obvious imbalance, and in response to the problem of data reproducibility when protein reagents are involved, a working group comprised of members of both the ARBRE-MOBIEU and the P4EU networks produced a list of recommended tests (QC Guidelines – reported in Supplementary Note  1 and accessible at https://p4eu.org/protein-quality-standard-pqs or https://arbre-mobieu.eu/guidelines-on-protein-quality-control ). These guidelines were developed with reference to the available literature 12 , 14 and the extensive professional experience of the working group members, to aid in the validation of protein samples used in biological research. They have been embraced by a wide community of specialists (a full list of these researchers can be found on ARBRE-MOBIEU and P4EU website) and comprise three parts: (1) minimal information, (2) minimal QC tests, and (3) extended QC tests. We propose a list of minimal QC tests that are based on simple experimental methods that are widely available (Supplementary Table  1 and Supplementary Note  1 , Supplementary Figs.  1 – 7 ). Together with this minimal information, we feel that these or similar disclosures should become compulsory documents in any submission to scientific journals when using protein/peptide reagents. While generally considered complementary, extended QC tests may be considered essential when using the proteins in specific experimental downstream applications. Our protein QC guidelines are summarized described below and schematically illustrated (Fig.  1 ).

The actual DNA sequence of the clone must be verified for its identity/correctness (correspondence to original clone, no mutations) before starting its expression. Following purification, the identity of the protein must be confirmed (by Mass Spectrometry), its purity and integrity evaluated (SDS-PAGE/CE), and its homogeneity (i.e., size distribution/aggregation state) checked to assess size distribution (i.e., monodispersity/polydispersity). The most accessible tests are reported (SEC, DLS), alternatives can be found in the guidelines. If all minimal QC tests are passed, proteins should be tested for further properties, e.g. their functionality or their folding state before being used as reagents. Further analyses are necessary for specific protein applications, as it can be the case of DNA contaminations (extended tests described in the on-line guidelines/SN1), and to evaluate the possibility to store the protein. If proteins do not pass any of the check steps, their production/storage process should be optimized. Summarizing, the minimum QC relies on three parameters (i.e., identity, purity, integrity and homogeneity) requiring three (first-line) analytical methods only. As indicated, it is possible to choose between alternatives: SDS-PAGE or CE, analytical SEC or DLS. The requirement in terms of protein is roughly 100 μg [SDS-PAGE, 10 μg (Coomassie blue staining); Mass Spectrometry, 60 μg; Analytical SEC, 30 μg (for Dynamic Light Scattering, 20 μg, the sample can be recovered)]. UV-Visible spectrophotometry is advised since the protein is recycled and several pieces of information can be rapidly collected (Supplementary Note  1 ).

Minimal information

For recombinant proteins, the complete sequence of the construct used in the reported experiments should be made available and we highly recommend confirming the sequence after cloning by sequencing to avoid wasteful production trials.

Expression, purification and storage conditions should be fully described such that they may be accurately reproduced in any laboratory.

The method used for measuring the protein concentration should be given

Minimal QC tests

Protein purity should be assessed by any of common techniques such as SDS-PAGE, Capillary Electrophoresis (CE), Reversed Phase Liquid Chromatography (RPLC). Mass Spectrometry (MS) and RPLC help to detect the presence of contaminating proteins, sample proteolysis and minor truncations.

Homogeneity/dispersity refers here to the size distribution of the protein sample, which can generally be correlated with oligomeric state (monomer, dimer etc.) or the presence of aggregates. Whereas poly-dispersity is not per se an indication of instability, preparations showing the presence of ‘incorrect’ oligomeric states or higher order ‘aggregates’ suggest that the protein may not be in an optimal/functional state. This can have a dramatic effect on the results of experiments to determine e.g. enzyme kinetics and protein-ligand interactions, essentially as a result of an overestimation of the concentration of active protein. Protein homogeneity/dispersity may be assessed by Dynamic Light Scattering (DLS), size exclusion chromatography (SEC) or, preferably, by SEC coupled to multi-angle light scattering.

The identity of a sample can be confirmed using either ‘bottom-up’ MS (mass fingerprinting or tryptic digests) or ‘top-down’ MS (by measuring intact protein mass). The former will confirm that the correct protein is being used and not e.g. a host protein of similar mass that has been purified in error. The latter will confirm the identity of the protein and will also indicate whether it has suffered any proteolysis during purification (intactness/micro-heterogeneity).

Extended QC tests

In addition to this short list of minimal/essential controls, other techniques are recommended to further characterize protein samples and their suitability as experimental reagents, for instance the folding state of proteins and the specific activity of enzymes. Proteins produced in Escherichia coli that are destined for use in experiments with cultured cells should be tested for the presence of lipopolysaccharides/endotoxins and UV spectrophotometry is mandatory for DNA/RNA binding proteins.

Examples in which protein quality assessment resulted in improvements of sample quality with critical impact on downstream experimental results are presented in supplementary information (Supplementary Note  2 , Supplementary Figs.  8 – 12 ). The results of a large scale survey among users who volunteered applying the guidelines in their routine experiments has also been carried out 15 .

Conclusions

In our experience, the application of the limited number of simple QC tests suggested above provides reliable indicators of the quality of the protein employed as experimental reagents, and yields more reproducible results in downstream applications. We believe that their implementation and the public availability of such QC data could therefore significantly increase the level of confidence in the published data resulting from the use of protein reagents, as well as the ability to reliably reproduce the experimental data.

This condition, which should ideally be the norm, is in reality challenged by several factors as reported in a recent survey 5 . Selective reporting, insufficient availability of raw data and the paucity of information in many ‘Materials and Methods’ sections are all factors which contribute to create opacity. The decline of the essential materials and methods sections of published papers dates back, understandably, to the times when many journals were available only in print and the pressures to minimize the sizes of submitted papers. With the advent of on-line publishing it is time to advocate the (re-) integration of these essential sections to their former status to allow other researchers to reproduce the data therein without resorting to making contact with the authors. Although this effect has been partly mitigated by the current availability of Supplementary Data sections in many on-line journals, the presented data often falls short of a full description of the experimental conditions used and often lacks any form of QC data relating to protein quality. The present interest of Editors for the systematic storage of (raw) data [ https://www.springernature.com/gp/open-research/open-data/practical-challenges-white-paper ] should consider also the inclusion of this methodological data.

We suggest that implementation of guidelines for protein quality evaluation should be considered an entry point towards the development of improved and ideally compulsory reporting practices of data obtained with protein reagents. It is our contention that ‘Supplementary Data’ sections should also contain details of the QC tests performed on any protein/peptide reagents used in a study, independent of the source of the protein reagent (commercial vendors or purified in an academic lab), in order to give referees and readers an indication of the quality of the materials being used to derive any given data set. To this effect, we suggest the development—in co-operation with journal editors—of a standardized form for QC reporting and annotation for authors to complete during the submission process. A model of such a checklist is illustrated in Supplementary Table  1 and could be made available to referees and editors but also published in the supplementary material to allow reader scrutiny. Finally, all the stakeholders—scientists, editors and funding agencies—will profit from improving data reliability and reproduction by means of systematic and accurate reagent QC. Such practices should minimize the wasteing of time and resources and, in addition, favor future metadata analysis.

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Acknowledgements

ARBRE-MOBIEU is supported by European CO-operation in Science and Technology (COST) Action number CA15126. We thank all the collaborating laboratories for providing results on their samples and also Leonard P. Freedman for permission to re-use his data (from ref. 3 ).

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Lab of Environmental and Life Sciences, University of Nova Gorica, Vipava, Vipava, Slovenia

• Ario de Marco

Protein Expression Core Facility, Institute for Research in Biomedicine (IRB Barcelona), The Barcelona Institute of Science and Technology, Barcelona, Spain

• Nick Berrow

Protein Purification Facility, Wolfson Centre for Applied Structural Biology, Edmund J. Safra Campus - The Hebrew University of Jerusalem, Jerusalem, Israel

• Mario Lebendiker

European Molecular Biology Laboratory (EMBL), Hamburg Outstation, Hamburg, Germany

Maria Garcia-Alai & Annabel Parret

Biochemistry IV - Biopolymers, University of Bayreuth, Bayreuth, Germany

• Stefan H. Knauer

Protein Production and Characterization Platform, Novo Nordisk Foundation Center for Protein Research, Copenhagen, Denmark

Blanca Lopez-Mendez

Laboratory of Enzymology and Protein Folding, Centre for Protein Engineering, Department of Life Sciences, University of Liège, Building B6C, Allée du 6 Août, 13, Liège, Belgium

André Matagne

Protein Expression and Purification Core Facility, EMBL Heidelberg, Heidelberg, Germany

Charles River Laboratories, Beerse, Belgium

Stephan Uebel

Institut Pasteur, Plateforme de Biophysique moléculaire, Department of Structural Biology and Chemistry, Paris, France

• Bertrand Raynal

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Contributions

A.deM., N.B., M.L., M.G.A., S.H.K., B.L.M., A.M., A.P., K.R, S.U, B.R. conceived the guidelines. A.deM., N.B., B.R. wrote the manuscript. G.A., S.H.K., B.L.M., A.M., A.P., K.R. and S.U. edited the manuscript.

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Correspondence to Bertrand Raynal .

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de Marco, A., Berrow, N., Lebendiker, M. et al. Quality control of protein reagents for the improvement of research data reproducibility. Nat Commun 12 , 2795 (2021). https://doi.org/10.1038/s41467-021-23167-z

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DOI : https://doi.org/10.1038/s41467-021-23167-z

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Please note you do not have access to teaching notes, a review on quality control in additive manufacturing.

Rapid Prototyping Journal

ISSN : 1355-2546

Article publication date: 9 April 2018

The usage of additive manufacturing (AM) technology in industries has reached up to 50 per cent as prototype or end-product. However, for AM products to be directly used as final products, AM product should be produced through advanced quality control process, which has a capability to be able to prove and reach their desire repeatability, reproducibility, reliability and preciseness. Therefore, there is a need to review quality-related research in terms of AM technology and guide AM industry in the future direction of AM development.

Design/methodology/approach

This paper overviews research progress regarding the QC in AM technology. The focus of the study is on manufacturing quality issues and needs that are to be developed and optimized, and further suggests ideas and directions toward the quality improvement for future AM technology. This paper is organized as follows. Section 2 starts by conducting a comprehensive review of the literature studies on progress of quality control, issues and challenges regarding quality improvement in seven different AM techniques. Next, Section 3 provides classification of the research findings, and lastly, Section 4 discusses the challenges and future trends.

This paper presents a review on quality control in seven different techniques in AM technology and provides detailed discussions in each quality process stage. Most of the AM techniques have a trend using in-situ sensors and cameras to acquire process data for real-time monitoring and quality analysis. Procedures such as extrusion-based processes (EBP) have further advanced in data analytics and predictive algorithms-based research regarding mechanical properties and optimal printing parameters. Moreover, compared to others, the material jetting progresses technique has advanced in a system integrated with closed-feedback loop, machine vision and image processing to minimize quality issues during printing process.

Research limitations/implications

This paper is limited to reviewing of only seven techniques of AM technology, which includes photopolymer vat processes, material jetting processes, binder jetting processes, extrusion-based processes, powder bed fusion processes, directed energy deposition processes and sheet lamination processes. This paper would impact on the improvement of quality control in AM industries such as industrial, automotive, medical, aerospace and military production.

Originality/value

Additive manufacturing technology, in terms of quality control has yet to be reviewed.

• Additive manufacturing
• Systematic review
• Quality control
• Data analytic and algorithm
• In-situ correction
• Real time closed-feedback loop

Kim, H. , Lin, Y. and Tseng, T.-L.B. (2018), "A review on quality control in additive manufacturing", Rapid Prototyping Journal , Vol. 24 No. 3, pp. 645-669. https://doi.org/10.1108/RPJ-03-2017-0048

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Why Is Quality Control in Research So Important?

Quality control can mean the difference between good science and bad science. So, what is quality control? Very simply, it is any process that aims to monitor and maintain laboratory standards.

The processes of quality control can include detecting, reducing, and correcting any problems within a lab. Quality control can also help to make sure that the results of an experiment or method are consistent. Quality control is known as quality assurance or quality management.

Good Laboratory Practice (GLP) is one form of quality control. GLP was introduced in the field of chemical research, to try to ensure high quality, reliable test data. This was a good starting point. However, it was not perfect.

What is the Best Type of Quality Control?

The best practice for quality control is a Laboratory Quality Management (LQM) program. The design of  LQM helps control factors that cause variation in a lab. By doing this, an LQM can increase the researcher’s confidence in the results of their experiments.

An LQM has six vital parts:

• Quality manual
• Labs should have a manual that describes its quality control systems in detail.
• Staff and training
• Training for all staff should be thorough and consistent.

3. Methodology

• The method must be consistent throughout the lab. They should be validated to check that they are precise and accurate.
• In-house reference materials
• This means that labs can have their control samples for standard methods. These samples will have known properties. They can be used to check that methods are working correctly.
• Record keeping
• Write down the preparation, procedure, and analysis of the experiment
• Cost vs. benefits
• The prices of setting up an LQM should be low. Benefits include confidence in results, fewer problems, and lower costs.

Tackling Problems in Quality Control

In a Nature article, a scientist describes her experiences with quality control. Rebecca Davies manages quality control at her lab for a long time. Although her task was huge, she soon became hooked on finding and fixing problems.

Once she started looking, Davies found several problems. These ranged from issues with sample storage to issues in data collection. She also discovered faulty equipment and spotted missing controls. However, these problems did not put Davies off. Instead, she realized how much the lab’s work could improve.

In 2009, Davies set up a group called Quality Central. The group helps several research labs to design proper quality control systems. Along with some other scientists, Davies believes in “voluntary” quality assurance (QA). Voluntary QA does not force quality control through regulation. Instead, it helps scientists to strengthen their research with QA.

What Happens when Quality Control is Poor

Scientific rigor is a hot topic. Over the last few years, several issues in science have caused both researchers and the public to question the scientific process. For example, some studies have found that as few as one-third of scientific papers are  reproduced . Peer review and plagiarism have also been a problem. Among researchers, there is a general opinion that publications are of more value than the science itself.

Many scientists are cautious in their work. However, some are careless. Failing to record data, writing reports months after the experiment and not using controls are just a few examples. Each of these may seem like a small problem. But together, they can lead to studies that cannot be reproduced.

We can fix a lot of issues with better quality control. Unfortunately, many labs still carry out quality control in a casual, ad hoc way.

Barriers to Good Quality Control

In many labs, quality control is not seen as the best use of resources. With limited funds, other things can take priority. Some scientists explain that a lack of quality control is due to both lack of funds and lack of staff.

When Davies first set up Quality Central, she found that other researchers at her college were not interested. They thought that it was not essential, and so was a waste of time and money.

However, one scientist was interested. The researcher had used another lab’s equipment, but the results seemed odd. She discovered that to save money, the PI of the lab had not been maintaining the equipment. Equipment maintenance is one of the things that a good quality control program should check

The Benefits of Great Quality Control

Thanks to the efforts of Davies and others, researchers are starting to understand the benefits of quality control.

Quality control does not need to be complicated. Here is one example. Notebooks checking is a weekly task in a laboratory. To make sure this is fair, each member of the lab draws a name from a paper bag to decide whose notebook they will check. Notebooks include factors such as whether control was used, how and where data was recorded, and which equipment was used. Any previous problems should be fixed. This is a tremendous low-tech quality control system.

Some PI’s with large labs find it hard to check everyone’s work. It can be challenging to track samples, data, and equipment. One solution is a tracking system. This gives tracking numbers to every sample or data record. PI’s can then easily follow the progress of a study.

Often, researchers only realize the benefits of quality control when problems occur. Unexpected results can mean searching through stacks of data to try to find the cause. With reasonable quality control, this should be a rare event. Moreover, if it does happen, the reason should be easy to find.

Do you want to learn more about running a lab? Alternatively, finding and fixing problems? Why not start with this Enago article on GLP.

What are the quality control systems in your lab? Has your work ever  suffered from poor quality control? Do you have any suggestions for improvement? Share your ideas in the comments below.

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Peer Review And Quality Control Research Paper

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Peer review is a mechanism for quality control in science, including the assessment of proposed projects and also of completed work. Its roots go back to the emerging science of seventeenth century, when novelty in natural knowledge became distinguished from technical invention and the ideals of reproducibility and publicity became established. Peer review was acknowledged by the mid-twentieth century as the unquestioned norm in ‘academic science.’ By then it was assumed that quality was unproblematic, owing to some special ethical disposition of scientists and their methods. With subsequent transformations in the social practice and context of science, which now extends into technology and policy, corresponding changes in quality assurance are needed. The crucial requirement is for a more encompassing community of those evaluating the products and processes of science (see, e.g., Stampa 1997).

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In most other spheres of institutional activity, the formalization of quality assurance has become the norm, as for example through the wide-ranging standard-setting procedures of the International Standards Organization (ISO). In academic science, however, along with cultural pursuits like the arts, the methods are still largely informal. Science has been almost unique in having self-assessment performed by practitioners rather than by external ‘critics.’ To what extent and in what ways this must change to keep pace with science’s expanding role in public life has become an urgent question in the governance of science.

The assurance of quality is not a straightforward task. This has been known since the time of the Romans, as indicated by the Latin motto quis custodiet ipsos custodes? (Who will guard the guardians themselves?). This motto implies an indefinite iteration. It is a reminder that, however, routine may be the tasks of quality control, full quality assurance demands yet higher levels of supervision at which informality and explicit value judgments are necessary.

As long as science remained mainly academic, problems of quality were assumed to be resolved by the very nature of the scientific endeavor. The informal systems of checking by peers seemed a rational response to the problem, rather than a culturally contingent mechanism characteristic of a particular epoch. Scientific facts were believed to be discovered by an infallible method, and scientists themselves were viewed as being endowed with certain superior moral qualities that protected them and their work from ordinary human failure or error. This self-correcting property of science could be explained in sociological terms, as in the ‘four norms’ of scientific practice expounded by Robert K. Merton in 1942 (Merton 1973), or philosophically, as in the committed attempts at self-refutation supposed by Karl Popper to be normal scientific practice (Popper 1959).

With the onset of the industrialization of science after World War II, the self-conscious study of science as a social activity, including the methods of quality assurance, became inevitable. Growth in size, capital investment, scale, and social differentiation within science created divisions between managers and research workers, as well as between researchers and teachers in universities. A Gemeinschaft (community) of scholars could no longer realistically be assumed. The earliest disciplined analyses of the quality of production in science were quantitative. Derek J. de Solla Price, who devised some measures of quality and provided analyses of its distribution, did the pioneering work. He noticed that at the leading British science reference library only a minority of journals was ever requested. The contents of the others could be inferred to have no interest, and hence to be of very low scientific quality (Price 1963). This phenomenon is a reminder that ‘quality’ is a relational attribute. ‘Fitness for purpose’ depends on whose purposes are dominant; not always perhaps those of a community devoted to the advancement of learning, but possibly only of those scientists working under constraints of ‘publish or perish.’

Price’s studies were continued in two directions. At the Institute for Scientific Information, Eugene Garfield produced more searching and sophisticated measures of quality, using citations rather than mere number of publications. Such attempts at quantification were bound to become controversial (Brooks 1982, Garfield 1970, 1972). It was impossible to avoid bias in the selection of the relatively small set of journals used for citations; those in conventional mainstream English-language research science were inevitably privileged at the expense of all others. Further, when quantitative measures of citations came to be used as indicators of academic merit, manipulative practices, including reciprocal citations, inevitably developed. The deep problems of a quantitative proxy for quality suddenly became acute.

In a more reflective vein, Jerome R. Ravetz applied the quis custodiet principle to analyze the vulnerability of the quality assurance system in science. He observed that the processes of peer review are conducted largely informally and (unlike research) are not themselves normally submitted to open scrutiny and review. They require a different sort of competence, which is not part of the formal training of scientists; and they are also more open to a variety of abuses, ranging from bias to plagiarism. One can understand the phenomena of low quality, both in scientific research and in technological development in these terms. Thus, while denying that the practice of science automatically produces a higher morality, Ravetz agrees that moral standards are necessary for the successful practice of science. On this basis he stresses the importance of morale and morality (and ultimately idealism and leadership) in science (Ravetz 1996).

This analysis provides a background for the increasing interest in ‘trust’ as an essential element of practice in science, in society, and in their interactions. The broader society has provided resources to the esoteric activities of science because it trusts the scientific community to make good use of them. There has always been an undercurrent of distrust, based on evidence either of pointless research or of malign applications. Once science became deeply involved in technology and related policy problems that crucially affect public health and welfare, the traditional relations of trust could no longer be assumed. It appeared to be necessary for the principles and practices of accountability to be extended from the institutions of political governance (as, e.g., representative democracy) to those institutions, which govern science and its applications.

Quality control in research science has become more difficult as the relatively inflexible technical requirements of the traditional printing process have been relaxed. There is no longer a well-defined ‘gateway’ to publication through the institutions that control reproduction of, and hence access to documents. First through inexpensive photocopying and now through the Internet, it has become easy for anyone to distribute scientific wares to an unrestricted audience. In addition, the presence of the global media tends to bypass the traditional processes of evaluation, which were conducted personally among colleagues. Isolated scientific results can become media events (Close 1991). All those with an interest in the report, such as consumers, politicians, regulators, and the stock markets, become potential stakeholders in the evaluation of the result. Thus, science arguably becomes accountable to a drastically extended peer community in the quality-assurance process. The criteria of quality applied by these heterogeneous actors need not be identical to those of ‘public knowledge’ generated within tightly knit scientific networks.

These developments may be judged in different ways. While they may seriously disrupt the procedures of quality assurance in normal science, they can also bring needed public scrutiny to bear on controversies and scandals. The demystification of scientific practice both enables such events to become news, and is fostered by their being exposed. Top scientists become like celebrities—needing the media for advertising themselves yet simultaneously hating it for its unwanted intrusions. The ‘Baltimore affair,’ centering on the US Nobel laureate David Baltimore’s laboratory at MIT, is perhaps the most notorious case in which a dispute about scientific misconduct was blown up into a lengthy, visible, political saga that damaged all the individuals and institutions involved (Kevles 1998). The episode was symptomatic of an increasingly recognized problem of ‘deviance’ in science, which carries the unspoken danger that, without timely correctives, misconduct might become the norm.

All these developments affect the maintenance of trust, which is necessary for ordinary scientific practice and even more for quality assurance. As in other professional domains, the normal tendency in science has been for misconduct to be covered up by the responsible institution (not necessarily by the community of scientists). In such situations, ultimate exposure does even more damage and further erodes the basis for mutual trust. Attempts to circumvent the need for trust by increasing bureaucratic surveillance are likely to be counterproductive in their own way, by erecting impediments to free inquiry and communication among colleagues.

The relations between social science and natural science have also been transformed during the last decades, with implications for quality control. Starting with the acceptance of natural science as the ideal of knowledge, essentially independent of social forces, there has been a gradual but accelerating shift toward recognizing all sciences as incorporating social constraints and biases. An early critical interaction was in connection with the astronomical community’s management of the eccentric Velikovsky (de Grazia 1966). Later, the social science community embraced Thomas Kuhn’s disenchanted picture of ‘normal’ science (Kuhn 1970). Finally, post-Feyerabend studies of science re-examined the whole institution of scientific inquiry without presupposing any privileged status in relation to either virtue or natural knowledge (Bloor 1991, Bloor et al. 1995, Collins and Pinch 1993, Fuller 1993).

When natural scientists, led by physicists, eventually confronted the emerging socialized picture of their discipline, the reaction was so strident that ‘science wars’ became an appropriate label (Gross et al. 1997, Nelkin 1996, Ross 1996). Sociologists of science and post modernists were indiscriminately blamed for all the ills of science, including decline of public trust, budget cuts, resurgent Creationism, and even poor teaching of science. A physicist whose hoax article (Sokal 1996) was accepted by a leading cultural studies journal, Social Text, helped to crystallize the attack (Bricmont and Sokal 1998). The implication was that the critics of science had no real quality control of their productions. The science warriors’ assumption was that within real science, such problems are prevented from occurring because of the verifiable empirical content of scientific research. In the ensuing debate, there was little mention of the ease of publication of erroneous or vacuous research in the standard scientific literature. Historical episodes, like Millikan’s manipulation of his oil-drop results in the course of a controversy on the charge of the electron, were discounted as mere embarrassments (Segerstale 1995).

It has been presupposed thus far that ‘science’ refers primarily to traditional basic research. But among contemporary forms of scientific practice, curiositydriven research with no regard for applications has been increasingly marginalized. A diversification has occurred, so that quality assurance must also be considered in such areas as mission-oriented and issuedriven research, forensic science (Foster and Huber 1997, Jasanoff 1995), and the provision of scientific advice for policy (Jasanoff 1990, Salter 1988). In addition, the products themselves and the media through which they are diffused increasingly are diversified. For example, patents are now a common outcome of a research process, and this form of intellectual property is radically different from traditional published papers (Myers 1995). Also, results are reported in unpublished consultancy advice and unpublished ‘gray literature’ or kept confidential within institutions or even totally sealed under ‘lawyer client confidentiality’ and legal settlement agreements. With traditional peer review as the norm, the challenges of quality assurance for these new products and processes are nearly unrecognizable. A genre of critical literature has developed, with some authors directing anger at the new contexts of scientific production (Huber 1991), and others more clearly appreciating the problems they present (Crossen 1994, Jasanoff 1990, 1995).

A parallel diversification has occurred in the types of knowledge production that are accepted as legitimate. The democratization of knowledge now extends beyond the juries who assess the quality of technical evidence in courts (Jasanoff 1998) to include those who master previously esoteric aspects of their predicament (e.g., illness, contamination, pollution, oppression, discrimination, exploitation) through special-interest groups or the Internet. In addition, claims of specialized or local knowledge are present in even more diverse contexts, as among indigenous peoples, and in systems of complementary or ‘traditional’ medicine. These claims are commanding increasing commercial and political support among various publics, as well as gaining explicit recognition in numerous international treaty regimes. As a result, a new philosophy of knowledge appears to be emerging, based on a new disciplined awareness of complexity, in which a plurality of legitimate perspectives is taken for granted (Funtowicz and Ravetz 1991). Modern science, with its characteristic methodology and social location, is part of this enriched whole, but not coextensive with it. The criteria and tasks of quality assurance must explicitly involve additional values and interests, incorporating even the ontological commitments of groups other than scientists. This new configuration has been termed postnormal science.

Quality assurance can, thus, be seen as a core commitment of postnormal science, replacing ‘truth’ as science’s ultimate regulative principle (Funtowicz and Ravetz 1992). Defined in terms of uncertainties and decision-stakes, quality assurance encompasses ‘public interest,’ ‘citizen,’ and ‘vernacular’ sciences. In a period of domination by globalized corporate science (Gibbons et al. 1994), this effort to make scientists accountable to interested groups presents a coherent conceptual alternative for the survival of the ‘public knowledge’ tradition of science. Collegial peer review is thereby transformed into review by an ‘extended peer community.’ This new form of quality assurance will be given its formal structure and routines by those heterogeneous actors who put it into practice.

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• Bricmont J, Sokal A D 1998 Fashionable Nonsense: Post-modern Intellectuals’ Abuse of Science. Picador, New York
• Brooks H 1982 Science indicators and science priorities. In: La Follette M C (ed.) Quality in Science. MIT Press, Cambridge, MA, pp. 1–32
• Close F H 1991 Too Hot to Handle: The Race for Cold Fusion. Princeton University Press, Princeton, NJ
• Collins H, Pinch T 1993 The Golem: What Everyone Should Know about Science. Cambridge University Press, Cambridge, UK
• Crossen C 1994 Tainted Truth: The Manipulation of Fact in America. Simon & Schuster, New York
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Maintenance and Quality Control of Medical Equipment Based on Information Fusion Technology

Jiansheng li.

1 Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Tongji Shanxi Hospital, Third Hospital of Shanxi Medical University, Taiyuan 030032, China

2 Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China

Associated Data

The data underlying the results presented in the study are available within the article

In the medical field, to ensure the use of large medical equipment, it is necessary to carry out regular maintenance on large medical equipment. In the process of maintenance and maintenance of large-scale medical equipment, most medical personnel have not established a corresponding quality management system, neglecting daily maintenance and maintenance, resulting in many hidden dangers of medical accidents. To this end, the quality control of large medical devices should be strengthened, the control before, during, and after the event should be done well, and a comprehensive analysis of the operation methods of the equipment should be carried out to achieve reasonable maintenance of the equipment. Therefore, this paper discusses the maintenance, management, maintenance, and quality management of large medical equipment under the function of information fusion technology. This paper summarizes the problems encountered in the maintenance of medical equipment in the past and creates a medical quality control system to manage the maintenance and quality control of medical equipment. In the maintenance system of medical equipment, scientific management theories and methods are used to predict, adjust, inspect, and account for the quality of the entire production process of the equipment, and establish a complete quality monitoring and management system. To achieve optimal maintenance and economic benefits, the overall quality of medical equipment can be comprehensively improved. The data shows that the actual number of monitors for quality control testing in 2020 is 502 units, 496 units have passed the initial inspection, and 502 units have passed the maintenance, which shows that the maintenance and quality control of medical equipment based on information fusion technology is effective.

1. Introduction

The survival and development of a hospital is inseparable from medical facilities. Strengthening the repair and maintenance of medical equipment can ensure the normal operation of the hospital and reduce medical expenses. With the use of medical devices, the hospital's treatment methods have also been further improved. In practical applications, due to the automation and complexity of medical devices, maintenance must change past habits during use. Maintenance personnel must regularly check related equipment, which puts forward higher requirements for the maintenance and management of medical equipment. Therefore, this paper discusses the maintenance and repair of large medical equipment. The maintenance and management of medical equipment ensures its superiority in use. The clinical application of medical equipment is essential, and its maintenance quality directly affects the work efficiency of the hospital, as well as the survival and health of patients. Therefore, it is necessary to carry out routine maintenance on existing medical devices and analyze their scientific and institutionalized advantages in operation, thereby greatly improving the service life of medical devices.

Research into the maintenance and quality control of medical equipment has been ongoing. Zheng discussed how to optimize the quality control of medical devices and improve the implementation effect of quality control, to improve the quality of medical devices and the level of clinical diagnosis and treatment [ 1 ]. Hao discussed the use of the Medatc system for inspection and failure statistics of hysteroscopic and laparoscopic equipment [ 2 ]. Saffarpur aimed to evaluate the effectiveness of curing light equipment routinely used in Karaj Dental Clinic in 2016 [ 3 ]. Jun evaluated the current situation and the current situation of quality control in the intensive care unit (ICU) of Sichuan Provincial Hospital of Integrated Traditional Chinese and Western Medicine and Minority Hospital [ 4 ]. Jose developed a series of technical quality control (TQC) guidelines for radiotherapy equipment [ 5 ]. Liu Y reviewed the current status and future trends of clinical quality control procedures and MRI equipment regulation [ 6 ]. The data information obtained by these studies is too simple, and the data is not integrated, so the value of the data cannot be fully utilized.

Many scholars have conducted research on information fusion technology. Du used the big data association rule mining method to realize the information fusion of mathematics teaching resources [ 7 ]. Zhang explored the potential of multisource information fusion techniques to improve model calibration and prediction performance in Chinese herbal medicine extraction process [ 8 ]. Shuai designed a fusion method of radar and electro-optical information [ 9 ]. These research fields do not cover the medical field, and there is also a lack of data support, so this paper studies the maintenance and quality control of medical equipment based on information fusion technology.

This paper takes several common medical equipments in a hospital as the research object and uses the equipment qualification rate as the research index to test the qualification rate before and after equipment maintenance. The data shows that the actual number of defibrillators tested for quality control in 2018 was 19, of which 16 passed the initial inspection and 18 passed the maintenance, indicating that equipment maintenance and quality control play a significant role in medical equipment.

2. Medical Equipment Maintenance and Quality Control

Medical equipment is different from both hospital equipment and medical equipment. Hospital equipment mainly includes two major parts: medical equipment and logistics equipment. Medical equipment and medical equipment include medical equipment and medical materials, appliances, software, etc. The conceptual relationship related to medical equipment is shown in Figure 1 .

Conceptual figures related to medical devices.

Large-scale hospital equipment maintenance needs to be improved:

The poor management of the acceptance of large medical devices has seriously affected the follow-up operation of the hospital. For example, in the purchase of large medical equipment, the hospital management model has some flaws and defects [ 10 , 11 ].

In the daily procurement, the large-scale equipment of the hospital is generally carried out by contract and then allocated according to the corresponding procedures. Due to the inability to carry out centralized management, it will cause some negligence of the distribution personnel during the transportation process, resulting in insufficient overall maintenance capability of the equipment [ 12 , 13 ].

During the acceptance process, because the hospital did not conduct inspections in time, the potential risks of medical devices could not be found in time. This has a negative impact on the subsequent use and maintenance of medical devices, thereby affecting the normal use of medical devices [ 14 , 15 ]. In addition, in the management of equipment, it has not reached the corresponding standard, and there is a big deviation. In addition, due to the unsound management mechanism of large medical equipment in the hospital itself, medical staff cannot perform effective operations when using them [ 16 , 17 ].

Many medical workers do not have a good attitude towards instruments in their daily inspection and use [ 18 , 19 ]. They thought that once a medical device was damaged, it would be repaired by the financial department of the hospital, not regularly repaired, nor regularly inspected according to the regulations. This leads to overloading of many devices, which shortens the life of the device. Once a fault occurs, it is difficult to find relevant information, and it is difficult to find the personnel responsible for it, which affects the information management level of the hospital and thus affects the subsequent development of the hospital. Therefore, in the future work, to realize the comprehensive development of the hospital, the first problem to be solved is the information management [ 20 , 21 ].

The elements of medical equipment maintenance are as follows:

The essence of the maintenance of medical equipment is to prolong the service life of the instrument, ensure the integrity and utilization rate of the instrument, and reduce the probability of failure during use [ 22 ]. In the maintenance department of the hospital, according to the characteristics and structure of the equipment, a new equipment maintenance plan was designed to ensure the safety and operation of the equipment. In the traditional security measures, the following methods can be used to optimize, such as regular inspections. In the daily inspection, regular maintenance of the instrument is also an important basis for equipment maintenance. Therefore, it is the key to ensure the safe operation of equipment to effectively prevent equipment safety accidents and to carry out regular maintenance and repairs.

Regular maintenance and preventive maintenance of the machinery are carried out on a regular basis to ensure that the machine can be cleaned regularly according to the technical requirements of the machine during normal operation. Then, perform a performance test. Detect damaged parts of machinery and equipment, analyze the overall condition of lines and waterways, and centrally optimize the operation of large medical equipment to ensure that both are fully functional.

To ensure the efficient development of the hospital, the equipment of the general department must be standardized and perfected and people-centered. Pay full attention to the improvement of the quality and skills of maintenance personnel, stimulate their enthusiasm for work, let them be assertive, take the patient as the center, take the survival and development of the hospital as their own responsibility, and adhere to the interests of society. Optimize the financial responsibility of the hospital to ensure that it can obtain new competitive forces in the market competition and achieve all-round development.

The quality control of large medical devices is as follows:

• Regularly organize training
• For the current medical equipment management, we ensure that the employees can consciously carry out the maintenance of medical equipment. For example, managers have to change their minds and adapt to large-scale medical devices. According to their professional skills and business level, choose excellent managers. In addition, after new equipment is put into service, employees must be regularly evaluated and trained. Equipment such as B-ultrasound and CT need to be licensed. After that, a responsibility control system was implemented for the quality inspection of the equipment, so that the defect behavior of the equipment was effectively implemented. At the same time, punish the causes of medical device failure due to personal reasons, urge operators to operate in accordance with standards, and improve the use, quality, and management level of medical devices.
• Implement the quality management system of equipment
• Implement the equipment quality control system in the standardized management, strengthen the large-scale medical equipment on the basis, improve the process of pre-purchase, in-purchase, use, etc., establish a set of evaluation systems and systems, and supervise the quality of medical equipment. For example, consider the entire quality management as the most critical step in the purchasing process. Pay more attention to relevant personnel and improve the quality of the overall equipment. To ensure the quality of medical devices, hospitals must conduct quality control and monitoring on a regular basis. Carry out a comprehensive inspection of the maintenance, installation, and debugging of the equipment, debug when purchasing the equipment, check the consistency of the equipment, and analyze the influencing factors in use to improve the quality of the equipment. For example, during use, the operator's working methods can be standardized, regular training can be organized, and comprehensive use and records of equipment, including maintenance records and maintenance records, can be done well. Ensure the timely control of existing problems and do a good job in the information management of large medical devices. With the continuous improvement of the level of medical informatization, the hospital must carry out a comprehensive management model reform, obtain new failure rates and maintenance rates, and conduct data analysis on them. In terms of medical device management, the latest mobile software technology and RFID technology are adopted to realize the monitoring and management of medical devices and ensure that the quality of large medical devices has reliable support.

Determine the quality assurance measures that should be taken according to the risk level of the equipment. During the implementation process, the effectiveness of risk control should be dynamically evaluated, and the risk estimation and risk analysis should be adjusted repeatedly. The risk assessment model is shown in Figure 2 .

Risk assessment model.

Risks are divided into six parts: equipment attributes, physical risk, equipment characteristics, safety performance, lethal state, and frequency of use.

The equipment properties and their risk scores are shown in Table 1 .

Device properties.

Physical risk mainly refers to the adverse consequences that may be caused by abnormal operation of the equipment, which can be summarized as death, injury, errors, etc. The physical risks and their risk scores are shown in Table 2 .

Physical risk.

The equipment characteristics and their risk scores are shown in Table 3 .

Device features.

The safety performance and its risk score are shown in Table 4 .

Safety features.

The lethal state and frequency of use are shown in Table 5 .

Lethal status and frequency of use.

The meaning of PDCA cycle is to divide quality management into four stages, namely, Plan (planning), Do (execution), Check (check), and Act (processing). In the quality management activities, it is required to make plans, implement the plans, and check the effect of implementation. Then, the successful ones are included in the standard, and the unsuccessful ones are left to the next cycle to solve. The quality control method adopts the PDCA cycle management method, as shown in Figure 3 .

PDCA cycle.

The overall level and ability of medical equipment control is concentrated in the medical equipment quality control system, which plays a great role in the management and control of hospital medical equipment, and depends on it to improve the overall medical level of the hospital. Hospitals not only need to closely integrate the construction of the medical equipment quality control system with their own characteristics, and learn from the research of scholars, but also follow the following principles:

Practical principles. All indicators of the medical equipment quality control system need to collect data in the form of questionnaires and then process the questionnaire data. Therefore, the index system must be practical, can truly reflect the overall level of medical equipment, and be easy to operate.

Scientific principles. The overall framework of the paper, the research objects, and the guiding methods are the cornerstones, and the index construction of the medical equipment quality control system can be scientific, rational, and justified.

Quantitative principles. The construction of the medical equipment quality control system is to prepare for later empirical research, so each index in the system needs to be mathematically quantified, to carry out the modeling and quantitative analysis of the empirical research.

In general, the life cycle of the designed equipment is determined by the quality of the medical equipment. Therefore, this paper first chooses the life cycle theory and the total quality management theory to select the indicators. Then, combine the previous research to classify the indicators, and finally determine the overall system indicators of medical equipment quality control combined with the risk management theory.

The existing problems in the quality control of hospital medical equipment are:

Insufficient quality inspection personnel. A common phenomenon in hospitals now is the lack of professionals. Many medical engineering technicians and some other medical personnel take into account the measurement and quality control work, which originally required professionals to be responsible. Because of the limited number of engineering and technical personnel and the large number of medical facilities, these technicians are usually only responsible for the management and maintenance of the facilities. This has led to problems such as overdue use and missed inspections in many facilities. Not only that, but some facilities have lost quality control.

Acceptance testing is not standardized enough. Hospitals only rely on personal feelings and experience to test whether newly purchased medical facilities are qualified. When the facility is checked and accepted, it is still the traditional way to check whether the outer packaging of the facility is in good condition, whether the relevant accessories are sufficient, and whether it can be powered on normally. This kind of verification to judge whether a facility is qualified or not based on simple external performance is seriously insufficient. There is no scientific and accurate reference index and verification basis for this method. In this way, the purchased equipment is often unqualified, and it is easy to make mistakes and dangers in clinical use.

The purpose of the construction of the medical equipment quality control system is to ensure that the stability, safety, and accuracy of the parameters of the equipment can be guaranteed. The specific work mainly includes the following three parts: The first is to ensure the formation of the organizational management system. Form a situation in which special personnel are responsible and leaders pay attention. And increase the supervision and management of the entire process, methods, and other links. Second, building a quality control process system can ensure that quality management is implemented in the entire life cycle of the equipment, and it can be continuously improved and improved in actual use. The third is the construction of the security system. Strengthen the allocation of special tools and professional testing personnel, to form a guarantee for the good operation of the quality control system.

The medical equipment quality control system is shown in Figure 4 .

Medical device quality control system.

The so-called quality inspection and control before the application of equipment is not only necessary to determine the comprehensiveness of its safety performance before the purchase of medical equipment, but also to sign an effective safety contract to ensure the quality level of the entire purchased medical equipment. At the same time, this is also the original step of equipment quality assurance.

Project demonstration quality control. In each department of the hospital, as long as there is a need for some high-risk medical equipment or equipment, professional project approval for the required equipment, as well as a wealth of data demonstration, must be carried out. At the same time, according to the relevant research data, we set up a special project report and establish a file. The main items that should be included are: all information and details related to the required medical equipment, and all feasibility assumptions related to the required equipment, as well as feasibility studies. At the same time, according to the risk and value of the required medical equipment, the setting and the reason for the need should be justified.

Plan approval for quality control. In the gradual development stage of science and technology, the detection and control of the safety factors of medical equipment and equipment in major hospitals is the primary prerequisite for medical development. At the same time, it is also an important basic prerequisite for adapting to the development of science and technology. Therefore, for the safety guarantee of medical equipment, it is necessary to carry out the planned quality inspection and control for approval. In terms of medical equipment, risks in the process of its use should be avoided, and procedures and projects that require technical content should be encouraged and supported, and attention should be given to action. For some more important and high-risk medical devices, it is necessary to conduct in-depth investigation and research by multi-level leaders and departments, as well as relevant high-level technical personnel. After obtaining the plan approval, it can be effectively implemented and used, to effectively control the quality and safety of plan approval.

Manufacturer selection quality control. For the purchase and investment of medical equipment required by the hospital, it is necessary to go through very strict procedures and steps to check and test the quality of the required products and equipment. Among them, first of all, it is necessary to confirm the relevant certificates of the purchased medical equipment manufacturers, for example, similar certificates such as the equipment registry and the manufacturer's authorization letter, must be strictly checked and tested. Secondly, it is to carry out careful measurement and evaluation of relevant health aspects. At the same time, health testing is also the most basic control and testing for the medical quality of medical manufacturers. Then, for the selection of medical equipment manufacturers and suppliers, the selection of medical equipment manufacturers should be determined according to the basic conditions of the manufacturers, such as safety and quality issues, and hygiene and technical aspects. Secondly, according to the various departments in the hospital, the equipment required, and the data displayed in the database, all manufacturers should be screened, to effectively complete the quality screening of medical equipment.

Business negotiation quality control. Regarding the selection of the medical equipment required by the hospital, at the stage of negotiation, the hospital's bidding form and the determination of the selection method should be used to negotiate the selection of medical equipment to achieve its quality control. To better ensure the safety, quality, and level of medical equipment, it is necessary to carry out strict and formal negotiation procedures and steps, that is, relevant personnel from many departments of the hospital should be integrated into the negotiation process.

Contract quality control. At present, the operation and development of many enterprises are inseparable from the establishment of contracts, and the same is true for hospitals. Therefore, in the purchase and setting of the required medical equipment, an effective, fair, and just contract should be established in accordance with the corresponding laws and regulations to carry out quality supervision and risk control. During the establishment of the contract, not only the approval of the relevant departments, but also more professional lawyers and personnel must be recruited to set the procurement standards. As well as the writing of the contract, from the establishment of the contract, as well as the approval and testing of the relevant hospital leaders and departments, the quality assurance and risk detection and control of the purchased necessary medical equipment.

Installation acceptance quality control. After purchasing, reviewing, negotiating, and signing the contract for the relevant medical equipment required by the hospital, the preordering activities of the medical equipment required by the hospital department and department are completed. The next step is the installation and acceptance of the overall equipment and the setting of the process. In the process of this step, the most critical and main problem is that the entire installation, configuration, and inspection need to be evaluated and tested to ensure the most basic safety and hygiene.

During the whole acceptance process, the supplier of medical devices should negotiate with the relevant departments and management personnel in the hospital to verify. For the purchased medical equipment, according to the testing of relevant national standards and the evaluation, standards of the military, quality control, and evaluation are carried out to fundamentally complete the evaluation of the quality and level of the equipment required by the hospital in terms of installation and acceptance. On the other hand, in this step, the risk detection of medical equipment, as well as the control of quality and level. It is also for the hospital to be able to cause safety problems and quality risks in the process of using the equipment in the future, resulting in some important medical failures and accidents.

The hospital selects and purchases the required medical equipment in a timely manner so that it can be used in the hospital. Then, in the whole process of using medical equipment, medical staff and various departments should use and operate them in strict accordance with the settings and standards of medical equipment. However, in the process of use, relevant personnel and department personnel should also carry out irregular and irregular quality inspection and inspection according to the purpose of the device. In this way, it can not only carry out quality control and risk prevention, but also find and solve problems in time.

In the hospital, regarding the use of medical equipment, it is necessary to carry out the clinical implementation and application of its equipment according to relevant regulations and reasonable suggestions, and to ensure safety issues and control the quality and level. With the development of the medical industry, major hospitals and related health departments, as well as managers of medical associations, have increased their awareness and attention to the safety of medical devices. It has also formulated relevant regulations and systems for the clinical implementation of medical equipment and equipment, the control of risk factors, and the prevention of quality. Faced with various problems and deficiencies in the process of clinical trials, diversified management methods and systems should be used to prevent and control risks.

In hospitals, many medical staff need to strengthen standardized actions and operating procedures for the use of related clinical equipment and product operations to improve the hospital's clinical implementation technology and efficiency for new medical equipment. Based on this, the hospital should provide the most basic and standardized training for the relevant medical staff in the hospital and the users of equipment at all levels. It is necessary to train not only the methods and procedures of the newly added equipment, but also the nursing methods of the relevant personnel, so as to fundamentally guarantee and control their quality.

One is equipment installation and acceptance training. The relevant new equipment users should be in the installation and acceptance stage of the new equipment, as well as the important control and debugging stage. To understand and learn the operation method of the equipment is not only very helpful for subsequent clinical experiments; at the same time, it can also learn a lot of equipment maintenance and repair knowledge, which is convenient for the protection of new equipment and reduces the safety risk of the equipment. The second is annual equipment use training. The hospital should conduct annual training on the operation and use of equipment for all doctors and related medical staff who can access and use the new equipment. At the same time, the hospital should also integrate the newly added clinical equipment, its use and operation, and the functions and skills of the relevant equipment into the assessment content according to the annual assessment of all medical staff. This can not only strengthen the medical staff's understanding and awareness of high-risk equipment, but also promote the hospital's quality control and management of these equipments. The third is to formulate operating procedures. Hospitals have complete procedures and procedures for the use and operation of medical equipment, which must be effectively implemented and managed. In addition to posting on the wall the use and control procedures of medical devices, the hospital also requires medical staff to carry out the steps of cleaning and testing high-risk devices one at a time, thereby reducing the quality risk of medical devices.

According to the legal systems and rules and regulations related to the hygienic use of medical devices and clinical operation issues proposed by the relevant medical departments and health management and assessment departments, that is, the strategy of the “Measures for the Management of Instruments and Equipment in Medical and Health Institutions” to fundamentally restrict and manage the relevant hospital medical staff and the implementation and operation of clinical equipment to improve the quality supervision and risk prevention and management of the overall equipment.

One is to insist on working with licenses. Hospitals should carry out strict handling and assessment of hospital medical staff who contact and use high-risk medical devices. After completing the prescribed standard tasks and passing, the clinical implementation and operation of medical devices can be carried out. Even for larger volumes such as ultrasonic medical equipment and DSA, it is necessary to pass the training and assessment of relevant physician certificates, and only after obtaining a formal employment certificate can the equipment be applied and controlled to ensure the quality management and risk supervision of medical equipment. The second is to establish a system of persons responsible for the use of medical equipment. The management personnel of the relevant departments of the hospital, as well as the medical equipment supervisors, shall register the persons responsible for the use and manipulation of the hospital medical equipment, form files and books, and register and manage their implementation and manipulation to ensure the quality control of the equipment.

In the clinical trial of the hospital, the regular maintenance and testing of medical equipment is a key step in its clinical implementation and application, and it is also the most important factor affecting the risk of medical equipment use. First, we do preventive maintenance for all staff. For the control and application of hospital medical equipment, not only the maintenance and management of managers is required, but also various departments and departments are required to carry out effective prevention and maintenance. It can be divided into departments or levels, and all staff participate in the maintenance, consideration, and testing of medical and health equipment, fundamentally improve the quality management and control of medical equipment, and avoid the emergence of high-risk risks. Second, emergency maintenance quality control. As a medical device commonly used in hospitals, risks and failures will occur from time to time. Therefore, the hospital should, according to this situation, formulate an all-day duty model and plan for the relevant maintenance department of the hospital, and let the maintenance workers work 24-hour shift mode to wait for the maintenance of the hospital's medical equipment at any time. When receiving a request for declaration of equipment maintenance, the medical equipment must be repaired in the shortest possible time to avoid more serious equipment failures. Fundamentally, the quality of medical equipment can be effectively controlled to prevent the occurrence of more serious risks. Finally, quality control after maintenance. To fully ensure the safety of equipment quality, a series of strict inspections and correlation tests must be carried out after handling equipment failures. All personnel related to the equipment should attach great importance to safety issues. After repairing the equipment that has been in the category of mandatory measurement and testing, and strictly inspecting the quality of all aspects of the medical equipment in time, only the equipment that has passed the overall quality can be officially used.

Scrap standard quality control. Under the specific service period stipulated by the relevant system, if the medical equipment still cannot be used normally or is lower than the normal quality standard after being repaired by the professional department, or equipment whose repair cost is too expensive or even exceeds the specified repair cost the standard can be applied for normal scrapping. However, the problems caused by real equipment are often intertwined and complex, and specific details such as the probability of equipment use, the objective environment of use, and maintenance will also have a great impact on the service life of the equipment. Instruments and equipment that have reached their end of life are widely available in practical work. However, because the relevant staff can properly operate and maintain the equipment, even if the equipment has exceeded the specified period of use, it still has a high operating quality. However, at the same time, many departments actively concealed the scrapping of equipment under the constraints of different factors.

Quality control of end-of-life equipment disposal. Relevant approval procedures are the directions that must be adhered to in the process of disposal of scrapped equipment. At the same time, the lasting use of relevant parts should be maintained as much as possible under the guidance of the idea of thrift first. The funds obtained after the scrapping process should be recorded in detail and reported to the financial department in the name of the funds for repairing and purchasing the provident fund.

This paper is based on the information fusion technology to realize the research on the maintenance and quality control of medical equipment. Measuring the information data δε (ϱ)(ϱ=1,2, ..., γ ) obtained at time ϱ and positioning it on the number axis, the absolute distance between the information data δε (ϱ) and δζ (ϱ) is set as:

The distance between δε (ϱ) and all information data is

The average distance between all informative data is

The set of all valid information data falling in the neighborhood is set as ι , if ϵ (ϱ) satisfies the following conditions:

Then, this set is called the optimized fuzzy set.

The fusion degree of δε (ϱ) and δζ (ϱ) is

Data fusion degree matrix:

The consistency fusion degree of sensor δε at time ϱ is

The distribution equilibrium is

The weight factor is

Normalized to get:

The fusion result is

Weighted evidence indicates the predictive power of the independent variable relative to the dependent variable. Weighted evidence:

Taking the weighted evidence as a reference and the global credibility of the evidence as the basis for measuring the weight coefficient of this piece of evidence, the weight coefficients of other evidence can be expressed as:

The basic confidence function is assigned as:

3. Maintenance Test

By establishing a quality control system for medical equipment, the stability and reliability of medical equipment have been improved year by year. This paper makes a statistical analysis of the data of hospital measurement and quality control in a hospital, and the analysis results are as follows.

The quality control test results of the sphygmomanometer and the weight scale in 2018, 2020, and 2022 are shown in Figure 5(a) and Figure 5(b) , respectively.

Quality control test results of sphygmomanometer and scale. (a) shows that the initial inspection pass rate of the sphygmomanometer in 2018 was 86.21%, and the pass rate after maintenance was 98.05%. The pass rate of initial inspection in 2020 is 84.86%, the pass rate after maintenance is 88.10%, the pass rate of preliminary inspection in 2022 is 95.25%, and the pass rate after repair is 97.68%. (b) shows that the first pass rate of the quality control test of the scale in 2018 was 76.52%, and the pass rate after maintenance was 96.26%. The pass rate of initial inspection in 2020 is 88.25%, the pass rate after maintenance is 95.70%, and the pass rate of preliminary inspection in 2022 is 95.21%, and the pass rate after repair is 100%. The qualified rate of the sphygmomanometer and the weight scale has been significantly improved after maintenance. It can be seen that the hospital equipment has been effectively improved after the practice of the medical equipment quality control system.

The quality control test results of the electrocardiograph and B-ultrasound in 2018, 2020, and 2022 are shown in Figures 6(a) and 6(b) , respectively.

Quality control test results of electrocardiograph and B-ultrasound. (a) shows that the initial inspection pass rate of the ECG machine in 2018 was 100%, and the pass rate after maintenance was 100%. The pass rate of the initial inspection in 2020 is 93.18%, the pass rate after maintenance is 100%, and the pass rate of the initial inspection in 2022 is 100%, and the pass rate after maintenance is 100%. (b) shows that the initial inspection pass rate of B-ultrasound quality control inspection in 2018 was 85.56%, and the pass rate after maintenance was 92.22%. The pass rate of initial inspection in 2020 is 93.63%, the pass rate after maintenance is 100%, and the pass rate of preliminary inspection in 2022 is 89.80%, and the pass rate after repair is 100%.

The quality control test results of the ventilator and anesthesia machine in 2018, 2020, and 2022 are shown in Figures 7(a) and 7(b) , respectively.

Quality control test results of ventilator and anesthesia machine. (a) shows that the initial inspection pass rate of the ventilator in 2018 was 42.64%, and the pass rate after maintenance was 89.52%. The pass rate of the initial inspection in 2020 is 100%, the pass rate after maintenance is 100%, and the pass rate of the initial inspection in 2022 is 100%, and the pass rate after maintenance is 100%. (b) shows that the initial inspection pass rate of the quality control inspection of the anesthesia machine in 2018 was 34.60%, and the pass rate after maintenance was 84.60%. The pass rate of initial inspection in 2020 is 70.32%, the pass rate after maintenance is 100%, and the pass rate of preliminary inspection in 2022 is 87.78%, and the pass rate after repair is 100%.

The quality control test results of the monitor and defibrillator in 2018, 2020, and 2022 are shown in Figures 8(a) and 8(b) , respectively.

Quality control test results for monitors and defibrillators. (a) shows that the actual number of monitors in the quality control test in 2018 was 122, of which 100 passed the initial inspection and 116 passed the maintenance. (b) The actual number of defibrillators in the quality control inspection in 2022 is 26, of which 23 have passed the initial inspection and 25 have passed the maintenance. To sum up, no matter what kind of medical equipment, it is fully maintained after repair and quality control, thus prolonging the service life of the equipment.

4. Conclusion

The quality management of medical devices is an important part of hospital management, and it is also an inevitable trend of hospital scientific and technological progress. By establishing the quality management system of medical equipment, combining it with the thought of management, and applying it to clinical management. Quantitatively and qualitatively analyze the reliability, maintainability, and security of the instrument, so that the quality of the medical device can meet the predetermined or potential demand. And combine quantitative and qualitative requirements into technical indicators, to give full play to the value of medical equipment. In addition, this paper analyzes the problems existing in the maintenance and quality control of existing medical equipment and gives three suggestions before, during, and after the maintenance to optimize the maintenance process. At the same time, the PDCA cycle method is used to control the quality of medical equipment. The medical equipment maintenance and quality control system is immature and cannot be applied to major medical systems. Therefore, it is necessary to improve the system to the extent that it can be widely used.

Data Availability

Conflicts of interest.

The authors declare that they have no conflicts of interest.

This paper is in the following e-collection/theme issue:

Published on 19.4.2024 in Vol 26 (2024)

Investigating the Cost-Effectiveness of Telemonitoring Patients With Cardiac Implantable Electronic Devices: Systematic Review

Authors of this article:

• Sarah Raes 1 , MSc   ; 
• Andrea Prezzi 1 , MSc   ; 
• Rik Willems 2 , PhD   ; 
• Hein Heidbuchel 3 , PhD   ; 
• Lieven Annemans 1 , PhD  

1 Department of Public Health and Primary Care, Ghent University, Gent, Belgium

2 Department of Cardiovascular Sciences, Universiteit Leuven, Leuven, Belgium

3 Department of Genetics, Pharmacology and Physiopathology of Heart, Blood Vessels and Skeleton (GENCOR), Antwerp University, Antwerp, Belgium

Corresponding Author:

Sarah Raes, MSc

Department of Public Health and Primary Care

Ghent University

Corneel Heymanslaan 10

Phone: 32 9 332 83 59

Email: [email protected]

Background: Telemonitoring patients with cardiac implantable electronic devices (CIEDs) can improve their care management. However, the results of cost-effectiveness studies are heterogeneous. Therefore, it is still a matter of debate whether telemonitoring is worth the investment.

Objective: This systematic review aims to investigate the cost-effectiveness of telemonitoring patients with CIEDs, focusing on its key drivers, and the impact of the varying perspectives.

Methods: A systematic review was performed in PubMed, Web of Science, Embase, and EconLit. The search was completed on July 7, 2022. Studies were included if they fulfilled the following criteria: patients had a CIED, comparison with standard care, and inclusion of health economic evaluations (eg, cost-effectiveness analyses and cost-utility analyses). Only complete and peer-reviewed studies were included, and no year limits were applied. The exclusion criteria included studies with partial economic evaluations, systematic reviews or reports, and studies without standard care as a control group. Besides general study characteristics, the following outcome measures were extracted: impact on total cost or income, cost or income drivers, cost or income drivers per patient, cost or income drivers as a percentage of the total cost impact, incremental cost-effectiveness ratios, or cost-utility ratios. Quality was assessed using the Consensus Health Economic Criteria checklist.

Results: Overall, 15 cost-effectiveness analyses were included. All studies were performed in Western countries, mainly Europe, and had primarily a male participant population. Of the 15 studies, 3 (20%) calculated the incremental cost-effectiveness ratio, 1 (7%) the cost-utility ratio, and 11 (73%) the health and cost impact of telemonitoring. In total, 73% (11/15) of the studies indicated that telemonitoring of patients with implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy ICDs was cost-effective and cost-saving, both from a health care and patient perspective. Cost-effectiveness results for telemonitoring of patients with pacemakers were inconclusive. The key drivers for cost reduction from a health care perspective were hospitalizations and scheduled in-office visits. Hospitalization costs were reduced by up to US $912 per patient per year. Scheduled in-office visits included up to 61% of the total cost reduction. Key drivers for cost reduction from a patient perspective were loss of income, cost for scheduled in-office visits and transport. Finally, of the 15 studies, 8 (52%) reported improved quality of life, with statistically significance in only 1 (13%) study ( P =.03).

Conclusions: From a health care and patient perspective, telemonitoring of patients with an ICD or a cardiac resynchronization therapy ICD is a cost-effective and cost-saving alternative to standard care. Inconclusive results were found for patients with pacemakers. However, telemonitoring can lead to a decrease in providers’ income, mainly due to a lack of reimbursement. Introducing appropriate reimbursement could make telemonitoring sustainable for providers while still being cost-effective from a health care payer perspective.

Trial Registration: PROSPERO CRD42022322334; https://tinyurl.com/puunapdr

Introduction

The implantation rates of cardiac implantable electronic devices (CIEDs), including pacemakers and implantable cardioverter-defibrillators (ICDs), have increased over the last decades due to expanded indications and a progressively aging population [ 1 ]. To evaluate the clinical status of the patient and device functioning, current guidelines recommend that older patients with pacemakers should be evaluated every 3 to 12 months and patients with ICDs should be evaluated every 3 to 6 months [ 2 ]. This regimen imposes a considerable burden on patients and physicians if the patient is required to be seen in person.

Telemonitoring, referring to the process of using telecommunication and information technology to monitor the health status of a patient and device function from a distance, can reduce this burden by replacing some in-office visits with transmissions from the patients’ home [ 3 ]. Existing research indicated that telemonitoring is safe (eg, experiencing equal major adverse events to standard care) [ 4 , 5 ]. The advantages of telemonitoring include fewer inappropriate shocks for patients with ICDs [ 4 , 6 ] and fewer hospitalizations for patients with atrial arrhythmias and strokes [ 4 , 6 , 7 ]. Moreover, there is a rapid detection of cardiovascular events and device malfunction [ 5 , 7 ], leading to a time reduction between clinical decision and intervention [ 8 ].

Besides the effectiveness of telemonitoring, patient experience is essential in high-quality health care services. Overall, patients with pacemakers on telemonitoring reported positive experiences comparable to the experience of patients with in-hospital monitoring [ 9 ]. Telemonitored patients with pacemakers tended to receive less information about their diagnosis but no significant differences were found in other items, such as confidence in clinicians, treatment decision involvement, treatment satisfaction, and waiting time before admission [ 9 ]. Another study indicated that telemonitoring of patients with a cardiac resynchronization therapy defibrillator (CRT-D) was time-saving for both patients and physicians [ 10 ].

Cost-effectiveness analyses are important to quantify the value of new interventions, informing both medical decision-making and public policy [ 11 ]. However, cost-effectiveness analyses depend on the perspective considered. The different perspectives are the health care payer perspective (eg, Medicare or Medicaid and British National Health Service), the patient perspective, the provider perspective (eg, physician), and the society perspective. The health care payer and societal perspectives differ from each other as the societal perspective includes indirect nonmedical costs (eg, transport) [ 12 ].

As cost-effectiveness analyses have shown heterogeneous results, it is still debatable whether telemonitoring is worth the investment relative to standard care. However, data on cost-effectiveness are important for health care payers to make decisions on the reimbursement of telemonitoring. Lack of reimbursement can be an important adoption barrier for new technology [ 13 , 14 ]. For these 2 reasons, this paper reviews the cost-effectiveness of telemonitoring, reviews how the results differ from different perspectives, and describes the key drivers of the cost-effectiveness of telemonitoring.

The review protocol was published by PROSPERO (International Prospective Register of Systematic Reviews; CRD42022322334). This systematic review was carried out in accordance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) reporting guideline of 2020 [ 15 ], and the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) [ 16 ], which can be found in the Multimedia Appendix 1 . Guidelines for preparing a systematic review of health economic evaluations were followed [ 17 ].

Literature Search

For this review, PubMed, Embase, EconLit, and Web of Science Core Collection were systematically searched. The last search was performed on July 7, 2022. No filters (eg, publication date or type of study) were applied. Search strategies for all electronic databases can be found in Multimedia Appendix 2 .

Search strings were developed based on explorations of databases and previous reviews. The following key concepts were translated into strings: (1) CIEDs, (2) telemonitoring, and (3) economic evaluations (eg, cost-effectiveness analyses and cost-utility analyses). The latter was based on a validated search filter, designed to identify economic evaluations, and was broadened for this study to maximize sensitivity [ 18 ]. The search terms for CIEDs and telemonitoring were based on existing reviews [ 19 - 21 ].

Study Selection

Studies were included if their primary focus was on the cost-effectiveness of telemonitoring patients with a CIED. The eligibility criteria were defined a priori for study selection ( Textbox 1 ). The population, intervention, comparator, and outcome strategy was applied to describe the criteria. Only complete and peer-reviewed studies were included. Specific exclusion criteria included partial economic evaluations, systematic reviews or reports, and studies without standard care as a control group. Only studies published in English, Dutch, French, or German were eligible for inclusion. The reference lists of the included studies were searched manually to identify relevant studies. Two reviewers (SR and AP) independently screened the titles and abstracts of all records using Rayyan (Rayyan Systems Inc) [ 22 ]. After the initial screening, full texts were retrieved and screened for a second time. The second screening round was independently performed by 2 reviewers (SR and AP). Reasons for exclusion were documented ( Figure 1 ). For both screening rounds, reviewers were blinded from each other’s decision, and disagreements were resolved through discussion.

Inclusion criteria

• Cardiac implantable electronic devices: pacemaker, implantable cardioverter-defibrillator, cardiac resynchronization therapy defibrillator, cardiac resynchronization therapy pacemaker, and loop recorder
• Standard care
• Complete health economic evaluations (within-trial and model-based)
• All settings
• English, French, German, or Dutch

Exclusion criteria

• Implantable pulmonary artery pressure monitor
• Partial health economic evaluations (outcomes related to costs or effectiveness only)
• Systematic reviews, reports, commentaries, congress abstracts, protocols, and animal studies

Quality Assessment

Two researchers (SR and AP) independently evaluated the original papers using the Consensus Health Economic Criteria (CHEC) checklist to assess the risk of bias [ 23 ]. The CHEC checklist included 19 items. Any disagreement was resolved by discussion and consensus. Interpretation of the CHEC list can be found in Multimedia Appendix 3 . The included studies were classified into 4 quality categories: excellent (score of 100%), good quality (score between 75% and 100%), moderate quality (score between 50% and 75%), and low quality (score <50%) [ 24 ].

Synthesis of Results

The study characteristics and main outcomes of the original papers are presented in the Results section. SR extracted all data. A data extraction sheet was developed using an existing template [ 17 ]. The following information was extracted from the included studies: study identification, general study characteristics, results, and authors’ conclusion. The principal outcome measures were health outcomes, cost or income outcomes (eg, the impact on total cost or income, cost or income drivers, cost or income drivers per patient, and cost or income drivers as a percentage of the total cost impact), and incremental cost-effectiveness ratios (ICERs) or cost-utility ratios.

To facilitate comparison across studies, the following adjustments and interpretations were made. First, the cost or income outcomes were presented per patient per year, and different currencies were converted to US Dollar (reference year: 2019 and reference country: United States) [ 25 ]. Second, perspectives were categorized into the health care payer perspective, patient perspective, provider perspective, and societal perspective. For the purpose of our study, the provider includes physicians who are directly involved in the care of patients with CIED.

The selection process is shown in Figure 1 . From a total of 3305 publications, 15 (0.45%) unique publications were reviewed. Studies were excluded because one of the following reasons: (1) intervention: the paper did not describe telemonitoring patients with a CIED; (2) outcome: the paper contained only a cost analysis and not a cost-effectiveness analysis; and (3) study design or publication: the paper was a partial health economic evaluation, congress abstract, protocol, systematic review, animal study, or with no peer review.

Characteristics of the included studies can be found in Table 1 . All 15 (100%) studies had a primarily male population, except for the Nordland study, which had an almost equal sex distribution ( Table 1 ) [ 26 ]. The mean age of the population with pacemakers was between 75 (SD 24.64) and 81 (SD 6.47) years. The mean age of patients with an ICD or CRT-D was between 61 (SD 12.6) and 69 (SD not calculated) years, except for the PREDICT RM study, where >50% of the population was aged >75 years [ 27 ]. Furthermore, of the 15 studies, 1 (7%) included only older patients (with a mean age of 81 years) with pacemakers [ 28 ], and 2 (13%) ICD or CRT-D studies only included patients with heart failure [ 11 , 29 ].

a CIED: cardiac implantable electronic device.

b N/A: not applicable.

c Age was a discrete variable in this study (higher of lower than 75 years old).

d ICD: implantable cardioverter-defibrillator.

e TARIFF: Health Economics Evaluation Registry for Remote Follow-Up.

f CRT-D: cardiac resynchronization therapy defibrillator.

g EVOLVO: Evolution of Management Strategies of Heart Failure Patients With Implantable Defibrillators.

h MORE-CARE: Monitoring Resynchronization Devices and Cardiac Patients.

i CONNECT: Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision.

j ECOST: Effectiveness and Cost of ICD Follow-Up Schedule With Telecardiology.

k EuroEco: European Health Economic Trial on Home Monitoring in ICD Patients.

l VVI-ICD: single-chamber ICD.

m DDD-ICD: dual-chamber ICD.

n SAVE-HM: Socio-Economic Effects and Cost Saving Potential of Remote Patient Monitoring.

Study Designs

Tables 2 and 3 show the summary table of results. Of 15 studies, 11 (73%) were conducted in Europe [ 11 , 26 , 28 - 32 , 34 , 35 , 37 ], 3 (20%) in the United States [ 27 , 33 , 38 ], and 1 (7%) in Canada [ 36 ]. Of the 15 studies, 3 (20%) calculated the ICER [ 26 - 28 ], 1 (7%) calculated the cost-utility ratio [ 11 ], and 11 (73%) calculated the cost impact of telemonitoring. All studies analyzed the health care payer perspective, with 33% (5/15) analyzing the patient perspective [ 11 , 28 , 30 , 32 , 34 ], 13% (2/15) analyzing the societal perspective [ 33 , 35 ], and 13% (2/15) analyzing the provider perspective [ 13 , 30 ].

b RCT: randomized controlled trial.

c QALY: quality-adjusted life year.

d ICER: incremental cost-effectiveness ratio.

e SAVE-HM: Socio-Economic Effects and Cost Saving Potential of Remote Patient Monitoring.

f N/A: not applicable.

g ICD: implantable cardioverter-defibrillator.

h CRT-D: cardiac resynchronization therapy defibrillator.

i TARIFF: Health Economics Evaluation Registry for Remote Follow-Up.

j EVOLVO: Evolution of Management Strategies of Heart Failure Patients With Implantable Defibrillators.

k The values are statistically significant.

l MORE-CARE: Monitoring Resynchronization Devices and Cardiac Patients.

m QOL: quality of life.

n CONNECT: Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision.

o ECOST: Effectiveness and Cost of ICD Follow-Up Schedule With Telecardiology.

p SF-36: The 36-Item Short Form Survey.

q EuroEco: European Health Economic Trial on Home Monitoring in ICD Patients.

a If the perspective is health care system or patient, then cost and if the perspective is provider, then income .

b pp: per patient (in health care and patient perspectives) or per physician (in provider perspective).

c The values are statistically significant.

d SAVE-HM: Socio-Economic Effects and Cost Saving Potential of Remote Patient Monitoring.

e ED: emergency department.

f ICD: implantable cardioverter-defibrillator.

g CRT-D: cardiac resynchronization therapy defibrillator.

h TARIFF: Health Economics Evaluation Registry for Remote Follow-Up.

i EVOLVO: Evolution of Management Strategies of Heart Failure Patients With Implantable Defibrillators.

j MORE-CARE: Monitoring Resynchronization Devices and Cardiac Patients.

k Costs were recalculated per patient.

l CONNECT: Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision.

m ECOST: Effectiveness and Cost of ICD Follow-Up Schedule With Telecardiology.

n EuroEco: European Health Economic Trial on Home Monitoring in ICD Patients.

Intervention and Comparator

Telemonitoring entailed data transmission and data review. Table 4 shows the frequencies of data transmission, review, and in-office visits of the included studies. In 47% (7/15) of the studies, data were transmitted continuously or daily [ 26 , 28 , 30 , 31 , 34 , 35 ]; in 20% (3/15) studies, data were transmitted after a device alert [ 8 , 11 , 29 ]; and in 13% (2/15) studies, data were transmitted every 3 months [ 32 , 33 ]. In 20% (3/15) of the studies, data review was performed daily [ 28 , 34 , 35 ]; however, in 40% (6/15) of the studies, it was performed after a device alert was received [ 8 , 11 , 26 , 29 - 31 ]. Besides data transmission and review, telemonitoring included scheduled in-office visits. In 33% (5/15) of the studies, all scheduled in-office visits were based on the protocol [ 11 , 13 , 29 , 30 , 35 ]. In 7% (1/15) of the studies, at least 1 scheduled in-office visit was protocol based [ 37 ]. In 3 (20%) of the 15 studies, only 1 scheduled in-office visit was protocol based [ 32 - 34 ]. Protocol-based in-office visits are described in Table 4 .

b pp: per patient.

c TARIFF: Health Economics Evaluation Registry for Remote Follow-Up.

d EVOLVO: Evolution of Management Strategies of Heart Failure Patients With Implantable Defibrillators.

e MORE-CARE: Monitoring Resynchronization Devices and Cardiac Patients.

g ECOST: Effectiveness and Cost of ICD Follow-Up Schedule With Telecardiology.

h EuroEco: European Health Economic Trial on Home Monitoring in ICD Patients.

i Save-HM: Socio-Economic Effects and Cost Saving Potential of Remote Patient Monitoring.

j ICD: implantable-cardioverter defibrillator.

k N/A: not applicable.

Effectiveness

Effectiveness results of telemonitoring can be found in Table 2 . Of the 15 studies, 9 (60%) investigated a quality-adjusted life year (QALY) or quality of life (QOL) difference [ 11 , 26 - 30 , 33 , 34 ]. A total of 53% (8/15) of studies reported an increase in QALY or QOL [ 11 , 26 - 28 , 30 , 33 , 34 , 39 ], but the QALY or QOL increase was only statistically significant in 1 (13%; P =.03) of the 8 studies [ 26 - 28 , 30 , 33 , 34 ]. In contrast, only 1 (11%) of the 9 studies investigating QOL or QALY reported a significant decrease in QOL [ 29 ]. Comparing all studies, QALY differences ranged from 0.03 to 0.27 in patients with pacemakers and ranged from −1 to 0.64 in patients with ICD or CRT-D.

Besides QALY or QOL, several studies reported other health outcomes. Chew et al [ 36 ] indicated that the risk of death was lower with telemonitoring. Al-Khatib et al [ 33 ] reported that mortality and general patient satisfaction with telemonitoring were equal to those of standard care. Crossley et al [ 8 ] reported that the time between the clinical event and the clinical decision was 17.4 days shorter in patients with an ICD or CRT-D on telemonitoring than in those on standard care ( P <.001). Burri et al [ 31 ] indicated that telemonitoring patients with ICD or CRT-D led to fewer inappropriate shocks (−51%) and a reduction in battery exhaustion (−7%). Raatikainen et al [ 32 ] indicated that telemonitoring patients with an ICD reduced the average total time spent on device follow-up, with 17 minutes per patient per follow-up for physicians and 175 minutes per patient per follow-up for patients. Similarly, Dario et al [ 37 ] indicated that the time spent by physicians to treat the patient reduced by an average of 4.1 minutes per follow-up in patients with pacemakers and an average of 13.7 minutes per follow-up in patients with an ICD (SD was not reported).

Economic Impact

The results of the economic impact of telemonitoring are presented in Table 2 . Of the 15 studies, 4 (27%) investigated the cost impact of telemonitoring in patients with pacemakers [ 26 , 28 , 35 , 37 ]. From a health care payer perspective, 1 (25%) of the 4 pacemaker studies indicated that telemonitoring increased costs with US $2183 per patient per year (not statistically significant) mainly because of increased hospitalization costs [ 26 ]. A total of 2 (50%) of the 4 pacemaker studies indicated that telemonitoring reduced costs by US $8.9 and US $1054 per patient per year mainly because of a reduction in hospitalization and staff costs, respectively [ 28 , 37 ]. Therefore, hospitalizations reduced costs in the study by Dario et al [ 37 ] but increased costs in the study by Lopez-Villegas et al [ 26 ]. From a patient and societal perspective, the results indicated that telemonitoring reduced costs by US $11 and US $1113 per patient per year, respectively, mainly because of lower transport costs [ 28 , 35 ].

Of the 15 studies, 13 (87%) investigated the cost or income impact of telemonitoring in patients with an ICD or CRT-D [ 8 , 11 , 13 , 27 , 29 - 37 ]. A total of 11 (85%) of the 13 ICD or CRT-D studies investigated the cost impact of telemonitoring from a health care payer perspective, all indicating that telemonitoring reduced costs for patients with an ICD or CRT-D [ 8 , 11 , 13 , 27 , 29 - 32 , 34 , 36 , 37 ]. A total of 9 (82%) of the 11 health care payer perspective studies indicated that hospitalization was the largest driver for cost reduction for patients with an ICD or CRT-D [ 8 , 11 , 13 , 27 , 29 , 30 , 34 , 36 , 37 ]. The hospitalization cost reduced by up to US $912.3 per patient per year [ 34 ]. In addition, scheduled in-office visits were reported as a driver for cost reduction in 5 (45%) of the 11 health care payer perspective studies, as up to 61% of the total cost reduction was due to a decrease in the number of scheduled in-office visits [ 11 , 29 , 30 , 32 , 34 ]. Besides cost drivers that reduced costs, there were also drivers that increased costs. In 3 (27%) of the 11 health care payer perspective studies, unscheduled visits increased the total cost impact of telemonitoring [ 11 , 13 , 29 , 30 , 33 ]. A total of 3 (20%) of the 15 studies indicated that the cost reduction for scheduled in-office visits outweighed the cost increase for unscheduled in-office visits (−US $81.4 vs US $15.6, −US $45.4 vs US $7.8, and −US $44.1 vs US $14/patient/year) [ 11 , 29 , 30 ].

The results of 4 (31%) of the 13 ICD or CRT-D studies that investigated the cost impact of telemonitoring from the patients’ perspective [ 11 , 30 , 32 , 34 ] indicated that patient and caregiver loss of work or activity [ 30 ], scheduled in-office visits [ 11 ], and transport [ 34 ] were the largest drivers for cost reduction. The results of 2 (15%) of the 13 ICD or CRT-D studies that investigated the income impact of telemonitoring from a provider perspective indicated that the loss of reimbursed (scheduled) in-office visits was the most important factor for income loss due to telemonitoring [ 13 , 30 ], reducing income by up to €72.7 (US $77.21) per patient per year [ 30 ].

ICER and Cost-Utility Ratio

Results on ICER and the cost-utility ratio are presented in Table 2 . Of the 15 studies, 3 (20%) calculated the ICER from a health care payer perspective [ 26 - 28 ] and 1 (7%) calculated the cost-utility ratio from a health care payer perspective [ 11 ]. Of the 15 studies, 2 (13%) calculating ICER were conducted with patients with pacemakers [ 26 , 28 ]. Notably, of the 2 studies, 1 (50%) indicated that telemonitoring was cost-effective (ICER: US $270.09/QALY) [ 28 ], and 1 (50%) indicated that telemonitoring was not cost-effective (ICER: US $64,410/QALY) [ 26 ]. For patients with an ICD or CRT-D, of the 2 studies, 1 (50%) indicated that telemonitoring was cost-effective (ICER: US $12,069/QALY) [ 27 ] and 1 (50%) indicated that telemonitoring was dominant [ 11 ].

Critical Appraisal

The critical appraisal of the individual studies is provided in Tables 5 and 6 . Of the 15 studies, 1 (7%) was classified as excellent (score of 100%) [ 13 ], 8 (53%) had a good quality score (100%<score>75%) [ 26 , 28 , 30 , 31 , 33 , 34 , 36 , 37 ], and 6 (40%) had a moderate quality score (75%<score>50%) [ 8 , 11 , 27 , 29 , 32 , 35 ]. A total of 3 (20%) of the 15 studies scored the lowest, with 59% each [ 8 , 29 , 32 ]. More than 50% (>8/15) of the studies scored low for the items cost valuation (item 9) [ 11 , 27 - 32 , 34 , 35 , 37 ], discounting (item 14) [ 8 , 11 , 29 , 30 , 32 , 34 , 35 , 37 ], and no conflict of interest (item 18) [ 8 , 11 , 27 , 29 , 30 , 32 , 34 , 35 ]. All studies scored high on the items study population (item 1), study design (item 4), time horizon (item 10), outcome identification (item 11), outcome measurement (item 12), and ethics (item 19).

a EuroEco: European Health Economic Trial on Home Monitoring in ICD patients.

b TARIFF: Health Economics Evaluation Registry for Remote Follow-Up.

c ECOST: Effectiveness and Cost of ICD Follow-Up Schedule With Telecardiology.

d Sufficient attention was given to this aspect.

e Insufficient attention was given to this aspect.

a Save-HM: Socio-Economic Effects and Cost Saving Potential of Remote Patient Monitoring.

b EVOLVO: Evolution of Management Strategies of Heart Failure Patients With Implantable Defibrillators.

c MORE-CARE: Monitoring Resynchronization Devices and Cardiac Patients.

d CONNECT: Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision.

e Sufficient attention is given to this aspect.

f Insufficient attention is given to this aspect.

g N/A: not applicable.

Principal Findings and Comparison With Prior Work

The primary aim of this study was to investigate the cost-effectiveness of telemonitoring patients with an ICD or CRT-D and a pacemaker from different perspectives.

From a health care payer perspective, most studies indicated that telemonitoring was a cost-saving and effective alternative to standard care. The most important driver for cost reduction was hospitalizations, both in patients with a pacemaker and those with an ICD or CRT-D. The cost of hospitalizations was reduced by up to US $912.3 per patient per year [ 34 ]. Moreover, the reduction of scheduled in-office visits was the second most important cost-saving factor in most ICD or CRT-D studies, with up to 61% of the total cost reduction. Previous research indicated that up to 55% of the device follow-ups were routine checks with no actionable events or device programming [ 35 , 40 , 41 ]. Several researchers pointed out that most scheduled in-office visits could be replaced by telemonitoring without affecting the quality of care [ 7 , 34 ] and with potentially diagnosing >99.5% of arrhythmia and device problems [ 41 ]. Although scheduled in-office visits decreased, our results show that unscheduled in-office visits increased because of telemonitoring patients with an ICD or CRT-D, probably because of the possible faster detection of arrhythmia and device malfunction by telemonitoring [ 8 ]. However, in all studies analyzing both scheduled and unscheduled in-office visits, the cost reduction for scheduled in-office visits outweighed the cost increase for unscheduled in-office visits [ 11 , 29 , 30 ].

From a patient perspective, our results indicated that the reduction of professional activity, transport time, and costs due to scheduled in-office visits are the most important factors for cost reduction.

The provider perspective was investigated less frequently in the included studies, although it is very relevant. Owing to the reduction of scheduled in-office visits, providers will lose income with telemonitoring if no reimbursement exists for telemonitoring but only for in-office visits. As a result, providers will be stimulated to maintain the classic follow-up instead of telemonitoring. Of the 15 studies, 1 (7%) observed that the total cost for insurance payers does not increase in countries where telemonitoring is reimbursed [ 13 ]. As telemonitoring decreases the overall costs from a health care payer perspective, there is room for proper compensation for providers to transition from in-office care to remote care. Hence, correct compensation (which is possible while still saving on the overall health care cost) will stimulate providers to switch to telemonitoring as the desired care path for patients with a CIED.

All studies reported the effectiveness of telemonitoring. Of the 15 studies, 9 (60%) indicated a QALY or QOL difference. Furthermore, 89% (8/9) of these studies indicated an increase in QALYs or QOL for telemonitoring patients with pacemakers or ICD or CRT-D, ranging from −1 to 0.64. Some studies (3/9, 33%) indicated this QALY or QOL increase was the result of the reduced routine in-office visits [ 7 , 34 ]. However, the QALY or QOL increase was only statistically significant (and positive) in 1 (11%) of the 9 studies [ 11 ]. Nevertheless, patient questionnaires have demonstrated a high acceptance of telemonitoring among patients with pacemakers and those with ICDs [ 39 ]. Moreover, telemonitoring is reported to lead to an increased sense of security [ 39 ]. Furthermore, the results indicated that telemonitoring leads to fewer inappropriate shocks, an important determinant of QALY, in patients with an ICD or CRT-D [ 31 ].

The cost-effectiveness analyses may be sensitive to the heterogeneity among the organization of telemonitoring in different hospitals. This may include different devices, the number of transmissions, the configuration of alerts, and hospital visit scheduling [ 26 ]. It seems reasonable to expect that the efficiency of telemonitoring not only depends on the technology but also on the organization of the service. If hospitals see telemonitoring as an additional service, on top of standard care, less cost-savings may be seen than if hospitals see telemonitoring as a substitute for standard care. A radical organizational change could lead to larger cost-savings, as suggested by an observational study by Facchin et al [ 42 ]. Moreover, such radical change may include a strategy involving other physicians, such as general practitioners, and referring cardiologists, that is, an integrated health care delivery [ 37 ].

Furthermore, the comparison between studies is challenged by differences in study design. The Poniente study by Bautista-Mesa et al [ 28 ] followed up patients with pacemakers for 12 months and indicated a QALY increase of 0.09 for telemonitoring. However, after 5 years of follow-up, the results indicated a QALY decrease of 0.20 for telemonitoring. Bautista-Mesa et al [ 28 ] indicated that some of the telemonitoring benefits (eg, reduction of in-office visits) may not be appreciated in the long term. Therefore, the evolution of utilities may be different depending on the follow-up time. In addition, the results indicated that hospitalizations reduced costs in the study by Dario et al [ 37 ] but increased costs in the study by Lopez-Villegas et al [ 26 ]. This discrepancy might be explained because significantly fewer patients were included in the study by Lopez-Villegas et al (50 vs 2101 patients). None of the 25 patients in the conventional follow-up group were hospitalized, whereas 12% (3/25) of the patients were hospitalized in the remotely monitored group (all for pacemaker problems) [ 26 ]. Furthermore, the included studies relied disproportionally on male participants, except for the Nordland study [ 26 ]. This may be explained by the significant sex disparity in ICD implantation rates, pointed out by Ingelaere et al [ 43 ]. Ingelaere et al [ 43 ] could not completely explain these differences by prevalence differences of cardiomyopathies and imply a possible undertreatment of women. Another study [ 44 ] observed an undertreatment of women with coronary heart disease, as they are less likely to undergo coronary angiography. Therefore, men may undergo more expensive treatments than women. This can explain why the included cost-effectiveness studies may present an overly positive result. In addition, time differences may impact the quality and cost-effectiveness of telemonitoring, as telemonitoring may evolve over time. However, our results did not provide meaningful insights in this respect.

The cost-effectiveness analyses may be sensitive to the heterogeneity among health care systems. From a provider perspective, our results indicated that telemonitoring generates lesser profit than standard care in the absence of reimbursement. Therefore, the lack of reimbursement is generally perceived as a major implementation barrier to telemonitoring, affecting 80% of the centers [ 45 ]. Consequently, providers tend to continue with standard care instead of telemonitoring. However, from a health care payer perspective, our results indicated that telemonitoring was still cost-saving even with reimbursement [ 13 , 34 ]. To stimulate providers to use telemonitoring, provider compensation should be provided based on overall health care cost-savings, making telemonitoring possible if it is preferred as the way to deliver CIED follow-up care.

Limitations

Because of the large discrepancies between health care systems’ organization, costs, access, delivery, quality, and reimbursement of cardiac care, any generalization may be perceived as inaccurate [ 37 , 46 ]. For instance, the included studies were mainly performed in Western countries. The results may not be generalizable to non-Western countries. Therefore, the cost-effectiveness results are contingent on the context in which they were analyzed [ 46 ]. Another limitation of this research is that 40% (6/15) of the included studies are not randomized controlled trials. These studies may have unobserved confounding factors that cannot be controlled for. Finally, cost analyses were excluded in this study because of our research objective. However, future cost analyses could draw a lot of information from analyzing these excluded studies.

Conclusions

Telemonitoring patients with CIED may be a cost-effective alternative to standard follow-up. Moreover, telemonitoring may lead to a cost reduction from a health care and patient perspective, mainly by the reduction of hospitalizations and scheduled in-office visits. Owing to the reduction in scheduled in-office visits, providers’ income tends to decrease when implementing telemonitoring without proper reimbursement. Introducing appropriate reimbursement could make telemonitoring sustainable for providers, while still being cost-effective from a health care payer perspective.

Acknowledgments

The authors would like to thank Dr Ingrid Kremer of Maastricht University for her help in the manuscript review. This work was supported by the Fund for Scientific Research Flanders (Fonds Wetenschappelijk Onderzoek Vlaanderen, grant 1SC9322N, 2021). RW is supported as a postdoctoral clinical researcher by the Fund for Scientific Research Flanders (Fonds Wetenschappelijk Onderzoek Vlaanderen).

Data Availability

All data generated or analyzed during this study are included in this published article and its multimedia appendices.

Authors' Contributions

SR and LA were responsible for the conceptualization of the manuscript. SR, LA, RW, and HH acquired the financial support necessary for this paper and developed the methodology. SR analyzed and investigated the data. AP, LA, RW, and HH validated the results. SR was responsible for the first and final drafts. LA, RW, and HH were involved in editing the drafts. All authors approved the final manuscript.

Conflicts of Interest

RW reports research funding from Abbott, Biotronik, Boston Scientific, and Medtronic and speakers and consultancy fees from Medtronic, Boston Scientific, Biotronik, and Abbott. None of these payments were personal; all were handled through the University of Leuven. HH received personal lecture and consultancy fees from Abbott, Biotronik, Daiichi-Sankyo, Pfizer-BMS, Medscape, and Springer Healthcare Limited. He received unconditional research grants through the University of Antwerp and the University of Hasselt from Abbott, Bayer, Biotronik, Biosense Webster, Boston Scientific, Boehringer Ingelheim, Daicchi-Sankyo, Fibricheck or Qompium, Medtronic, and Pfizer-BMS, all outside the scope of this work. All other authors declare no other conflicts of interest.

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Abbreviations

Edited by T Leung; submitted 28.03.23; peer-reviewed by P Jeurissen, B Dechert; comments to author 07.09.23; revised version received 13.09.23; accepted 13.02.24; published 19.04.24.

©Sarah Raes, Andrea Prezzi, Rik Willems, Hein Heidbuchel, Lieven Annemans. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 19.04.2024.

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