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Annales de Biologie Clinique Oct 2019In order to achieve regulatory compliance and acquire authorisation for sale in Europe, each medical device must be supported by a clinical evaluation report (CER) which... (Review)
Review
In order to achieve regulatory compliance and acquire authorisation for sale in Europe, each medical device must be supported by a clinical evaluation report (CER) which documents the clinical evaluation process in its entirety. This is not a new requirement but highly publicised scandals caused by defective medical devices increased scrutiny of notified bodies (the organisations designated by the European Union to evaluate medical device compliance) meaning they are more liable and must strengthen their inspections of medical device manufacturers. Manufacturers are already under increased pressure due to the new EU Medical device regulation published in 2017. The scope of the new regulation requires many manufacturers to evaluate the documentation for their whole product portfolio. CERs are an important part of regulatory compliance and are also one of the biggest challenges for manufacturers who do not have sufficient resources and do not dedicate enough time to this task. This article examines the background of this requirement while offering medical device manufacturers advice for successful clinical evaluation reports.
Topics: Documentation; Equipment Safety; Equipment and Supplies; European Union; Guideline Adherence; Humans; Manufacturing Industry; Medical Device Legislation; Patient Safety
PubMed: 31466939
DOI: 10.1684/abc.2019.1473 -
Yakugaku Zasshi : Journal of the... 2016In this presentation, as a member of the Harmonization by Doing (HBD) project, I discuss the significance of regulatory science in global medical device development and... (Review)
Review
In this presentation, as a member of the Harmonization by Doing (HBD) project, I discuss the significance of regulatory science in global medical device development and our experience in the international collaboration process for medical devices. In Japan, most innovative medical therapeutic devices were previously developed and exported by foreign-based companies. Due to this device lag, Japanese had minimal opportunities for receiving treatment with innovative medical devices. To address this issue, the Japanese government has actively accepted foreign clinical trial results and promoted global clinical trials in projects such as HBD. HBD is a project with stakeholders from academia, regulatory authorities, and industry in the US and Japan to promote global clinical trials and reduce device lags. When the project started, medical device clinical trials were not actively conducted in Japan at not just hospitals but also at medical device companies. We started to identify issues under the concept of HBD. After 10 years, we have now become key members in global clinical trials and able to obtain approvals without delay. Recently, HBD has started promoting international convergence. Physicians and regulatory authorities play central roles in compiling guidelines for the clinical evaluation of medical device development, which will be a more active field in the near future. The guidelines compiled will be confirmed with members of academia and regulatory authorities in the United Sates.
Topics: Clinical Trials as Topic; Device Approval; Equipment Design; Equipment Safety; Equipment and Supplies; Guidelines as Topic; Internationality; Japan; United States
PubMed: 27040333
DOI: 10.1248/yakushi.15-00224-1 -
Trials Sep 2017Medical devices play an important role in the diagnosis, prevention, treatment and care of diseases. However, compared to pharmaceuticals, there is no rigorous formal... (Review)
Review
BACKGROUND
Medical devices play an important role in the diagnosis, prevention, treatment and care of diseases. However, compared to pharmaceuticals, there is no rigorous formal regulation for demonstration of benefits and exclusion of harms to patients. The medical device industry argues that the classical evidence hierarchy cannot be applied for medical devices, as randomised clinical trials are impossible to perform. This article aims to identify the barriers for randomised clinical trials on medical devices.
METHODS
Systematic literature searches without meta-analysis and internal European Clinical Research Infrastructure Network (ECRIN) communications taking place during face-to-face meetings and telephone conferences from 2013 to 2017 within the context of the ECRIN Integrating Activity (ECRIN-IA) project.
RESULTS
In addition to the barriers that exist for all trials, we identified three major barriers for randomised clinical trials on medical devices, namely: (1) randomisation, including timing of assessment, acceptability, blinding, choice of the comparator group and considerations on the learning curve; (2) difficulties in determining appropriate outcomes; and (3) the lack of scientific advice, regulations and transparency.
CONCLUSIONS
The present review offers potential solutions to break down the barriers identified, and argues for applying the randomised clinical trial design when assessing the benefits and harms of medical devices.
Topics: Endpoint Determination; Equipment and Supplies; Humans; Randomized Controlled Trials as Topic; Research Design; Risk Assessment; Time Factors; Treatment Outcome
PubMed: 28903769
DOI: 10.1186/s13063-017-2168-0 -
Journal of Biomedical Optics Dec 2017The process of medical device innovation involves an iterative method that focuses on designing innovative, device-oriented solutions that address unmet clinical needs....
The process of medical device innovation involves an iterative method that focuses on designing innovative, device-oriented solutions that address unmet clinical needs. This process has been applied to the field of biophotonics with many notable successes. Device innovation begins with identifying an unmet clinical need and evaluating this need through a variety of lenses, including currently existing solutions for the need, stakeholders who are interested in the need, and the market that will support an innovative solution. Only once the clinical need is understood in detail can the invention process begin. The ideation phase often involves multiple levels of brainstorming and prototyping with the aim of addressing technical and clinical questions early and in a cost-efficient manner. Once potential solutions are found, they are tested against a number of known translational factors, including intellectual property, regulatory, and reimbursement landscapes. Only when the solution matches the clinical need, the next phase of building a "to market" strategy should begin. Most aspects of the innovation process can be conducted relatively quickly and without significant capital expense. This white paper focuses on key points of the medical device innovation method and how the field of biophotonics has been applied within this framework to generate clinical and commercial success.
Topics: Equipment and Supplies; Inventions; Optics and Photonics
PubMed: 29243414
DOI: 10.1117/1.JBO.23.2.021102 -
BioMed Research International 2015The implementation of an effective quality management system has always been considered a principal method for a manufacturer to maintain and improve its product and... (Review)
Review
The implementation of an effective quality management system has always been considered a principal method for a manufacturer to maintain and improve its product and service quality. Globally many regulatory authorities incorporate quality management system as one of the mandatory requirements for the regulatory control of high-risk medical devices. The present study aims to analyze the GMP enforcement experience in Taiwan between 1998 and 2013. It describes the regulatory implementation of medical device GMP requirement and initiatives taken to assist small and medium-sized enterprises in compliance with the regulatory requirement. Based on statistical data collected by the competent authority and industry research institutes, the present paper reports the growth of Taiwan local medical device industry after the enforcement of GMP regulation. Transition in the production, technologies, and number of employees of Taiwan medical device industry between 1998 and 2013 provides the competent authorities around the world with an empirical foundation for further policy development.
Topics: Equipment and Supplies; Humans; Manufacturing Industry; Quality Control; Taiwan
PubMed: 26075255
DOI: 10.1155/2015/670420 -
International Wound Journal Apr 2020Few studies, especially among developing countries such as Iran, have been conducted on the incidence and risk factors for medical device-related pressure ulcers...
Few studies, especially among developing countries such as Iran, have been conducted on the incidence and risk factors for medical device-related pressure ulcers (MDRPUs). Given the importance of this issue and the lack of previous studies, the present study aimed to investigate the incidence and risk factors for MDRPUs in Iran. The present descriptive-analytical study was conducted at three hospitals in Qazvin, Iran, from June 1, 2019, to September 1, 2019. Data collection took approximately 3 months from July to September 2019. Sampling was carried out through a convenience sampling method, and the samples consisted of 404 patients. For data collection, a checklist for demographic variables, a checklist for patient-connected medical devices, Braden Scale, Glasgow Coma Scale, National Pressure Ulcer Advisory Panel Pressure Grading Scale, and Nutrition Risk Screening 2002 were used. Of the 404 patients studied, 20.54% (n = 83) developed some degree of MDRPUs. From those, 61 (70.11%) were in stage I, 17 (19.5%) were in stage II, and 9 (10.34%) were in stage III. Among the nine medical devices that caused pressure ulcers, the most commonly reported ones were nasal oxygen tubes (31 cases), oxygen face masks (23 cases), and endotracheal tubes (17 cases). The mean score of Braden Scale (P = .004), the mean score of NRS 2002 (P = .037), older age (P = .007), male gender (P = .002), the average length of stay in hospitals (P = .001), and having pressure ulcers in body (P = .025) significantly increased the possibility of occurring MDRPUs. In the present study, the incidence of MDRPUs was high. Taking the necessary measures into consideration in order to prevent the MDRPUs is essential in Iranian hospitals. Further studies in this regard are strongly recommended.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Child; Equipment and Supplies; Female; Hospitals; Humans; Incidence; Iran; Male; Middle Aged; Pressure Ulcer; Retrospective Studies; Risk Assessment; Risk Factors; Young Adult
PubMed: 31854116
DOI: 10.1111/iwj.13290 -
Health Economics Feb 2017Much criticism has been directed at the licencing requirements for medical devices (MDs) as they often result in a lack of robust evidence to inform health technology... (Review)
Review
Much criticism has been directed at the licencing requirements for medical devices (MDs) as they often result in a lack of robust evidence to inform health technology assessment (HTA) decisions. To better understand the current international decisional framework on MD technologies, we undertook three linked research studies: a review of the device regulatory procedures, a survey of current HTA practices and an empirical comparison of HTA reports of drugs versus MDs. Our review confirms that current device regulatory processes across the globe are substantially less stringent than drugs. As a result, international HTA agencies report that they face a number of challenges when assessing MDs, including reliance on suboptimal data to make clinical and cost-effectiveness decisions. Whilst many HTA agencies have adapted their processes and procedures to handle MD technology submissions, in our comparison of HTA reports we found little evidence of the application of methodologies that take account of device-specific issues, such as incremental development. Overall, our research reinforces the need for better linkage between licencing and HTA and the development and application of innovative HTA methodologies with the objective of securing faster patient access for those technologies that can be shown to represent good value for money. © 2017 The Authors. Health Economics Published by John Wiley & Sons, Ltd.
Topics: Cardiac Rehabilitation; Cardiovascular Diseases; Cost-Benefit Analysis; Equipment and Supplies; European Union; Humans; Licensure; Outcome Assessment, Health Care; Patents as Topic; Reimbursement Mechanisms; Technology Assessment, Biomedical
PubMed: 28139087
DOI: 10.1002/hec.3479 -
PloS One 2021In the United States, medical devices are regulated and subject to review by the Food and Drug Administration (FDA) before they can be marketed. Low-to-medium risk novel...
BACKGROUND
In the United States, medical devices are regulated and subject to review by the Food and Drug Administration (FDA) before they can be marketed. Low-to-medium risk novel medical devices can be reviewed under the De Novo umbrella before they can proceed to market, and this process can be fairly cumbersome, expensive, and time-consuming. An alternate faster and less-expensive pathway to going to market is the 510(k) pathway. In this approach, if the device can be shown to be substantially equivalent in safety and effectiveness to a pre-existing FDA-approved marketed device (or "predicates"), it can be cleared to market. Due to the possibility of daisy-chaining predicate devices, it can very quickly be difficult to unravel the logic and justification of how a particular medical device's equivalence was established. From patients' perspective, this minimizes transparency in the process. From a vendor perspective, it can be difficult to determine the right predicate that applies to their device.
METHODS
We map the connectivity of various predicates in the medical device field by applying text mining and natural language processing (NLP) techniques on data publicly made available by the FDA 78000 device summaries were scraped from the US FDA 510(k) database, and a total of 2,721 devices cleared by the 510(k) regulatory pathway in 2020 were used as a specific case study to map the genealogy of medical devices cleared by the FDA. Cosine similarity was used to gauge the degree of substantial equivalence between two medical devices by evaluating their device descriptions and indications for use. Recalls and complaints for predicate devices were extracted from the FDA's Total Product Life Cycle database using html scraping and web page optical character recognition to determine the similarity between class 1 recalled devices (the most severe form of device recall) and other substantially equivalent devices. A specific product code was used to illustrate the mapping of the genealogy from a De Novo device.
RESULTS AND DISCUSSION
The ancestral tree for the medical devices cleared in 2020 is vast and sparse, with a large number of devices having only 1-2 predicates. Evaluation of substantial equivalence data from 2003-2020 shows that the standard for substantial equivalence has not changed significantly. Studying the recalls and complaints, shows that the insulin infusion pump had the highest number of complaints, yet none of the recalled devices bore significant degree of text similarity to currently marketed devices. The mapping from the De Novo device case study was used to develop an ancestry map from the recalled predicate (recalled due to design flaws) to current substantially equivalent products in the market.
CONCLUSIONS
Besides enabling a better understanding of the risks and benefits of the 510(k) process, mapping of connectivity of various predicates could help increase consumer confidence in the medical devices that are currently in the marketplace.
Topics: Databases as Topic; Device Approval; Equipment and Supplies; Medical Device Recalls; United States
PubMed: 34618861
DOI: 10.1371/journal.pone.0258153 -
Journal of Medical Economics 2015The only acceptable modeled claims for costs and outcomes are those that are testable and can be validated in a timeframe that is acceptable to a formulary committee....
The only acceptable modeled claims for costs and outcomes are those that are testable and can be validated in a timeframe that is acceptable to a formulary committee. This issue provides four papers which explore the methodological issues in validation, the UK experience with NICE, the questions a formulary committee should ask of modeled claims, and the role of Big Data in validating modeled claims.
Topics: Equipment and Supplies; Formularies as Topic; Humans; Models, Theoretical; State Medicine; Technology Assessment, Biomedical; United Kingdom
PubMed: 26549706
DOI: 10.3111/13696998.2015.1108920 -
EBioMedicine Sep 2015Marketing authorization holders (MAHs) are obligated to report adverse events (AEs) within 15 days (some cases 30 days) to the Pharmaceuticals and Medical Devices...
BACKGROUND
Marketing authorization holders (MAHs) are obligated to report adverse events (AEs) within 15 days (some cases 30 days) to the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan.
METHODS
To analyze the timeliness of AE reporting to the PMDA, 6610 reports for five categories of cardiovascular devices were retrieved. Two durations were calculated: (1) time from the date the AE occurred to that when the MAH captured it (DOC: days); and (2) time from the date of MAH capture to that of MAH report (DCR: days). Number of DOC > 15 days (DOC15) and delayed reports (DCR > 15 or 30 days) were also calculated.
RESULTS
AEs included 9.2% deaths and 7.5% non-recoveries. DOC15 and delayed reports were 51.0% and 10.9%, respectively. By multivariate analysis, DOC15 was associated with foreign AE, device category, MAH, patient outcome, event category, and AE that had to be reported within 15 or 30 days (AE15/30). Delayed report was associated with device category, MAH, patient outcome, event category, and AE15/30.
COMMENTS
Although Japanese MAHs complied with the obligation to report AEs, they often failed to share AEs with healthcare providers. Registry may be a potential solution, although the cooperation of healthcare providers to input data is essential.
Topics: Cardiovascular System; Equipment and Supplies; Humans; Japan; Logistic Models; Organizations; Pharmaceutical Preparations; Research Report
PubMed: 26501120
DOI: 10.1016/j.ebiom.2015.07.011