Regulación actual de los productos sanitarios: ¿es suficiente? / Current medical device regulation: Is that enough?

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[Medical devices industry: the problem of clinical evaluation reports]. / L'industrie des dispositifs médicaux : la problématique des rapports d'évaluation clinique.

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.

The changing regulatory landscape for biomedical implants and its relationship to withdrawal of some vaginal mesh products.

PURPOSE OF REVIEW: Advancements in biomedical engineering and advanced therapies including tissue engineering products necessitate revisions to the regulation and governance of their production and use to ensure patient safety. In this review, the current regulations and recent improvements on the governance of biomedical devices are reviewed. RECENT FINDINGS: Current regulations on approval of biomedical devices failed to address some important aspects related to the definition of biocompatibility of medical implants. The main issue was that the failure to establish design requirements for a specific application - in this case, the pelvic floor. Another issue was the lack of knowledge on disease mechanisms leading to an inability to define clear targets for surgical treatment. A clear example of this is the recent vaginal mesh scandal. SUMMARY: Surgical innovations are inherently challenging. It is no surprise that the regulatory landscape lags behind advancements in biomedical technologies. Very recent modifications to the available regulations particularly in Europe aim to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices, which ensures patient safety while supporting innovation.

New European medical device regulation: How the French ecosystem should seize the opportunity of the EUDAMED and the UDI system, while overcoming the constraints thereof.

The European regulation governing the placing on the market of medical devices (MD) provides for the gradual and mandatory phasing-in, within the European Union, of a unique device identification (UDI) system and a European database (EUDAMED) aimed at improving traceability and transparency of the market. The deployment of these tools will have a significant impact on the stakeholders of the medical device world (companies, health institutions, healthcare professionals, competent authorities, etc.). A strengths/weaknesses/opportunities/threats (SWOT) analysis conducted among the think tank participants shows real support for the objectives but also distinguishes a great deal of issues relating to the implementation of these tools. An inventory of the current traceability tools and databases used in France was then carried out to measure the gaps between the requirements of the European regulation and the current situation revealing that EUDAMED and the UDI system will ultimately have to slot into a complex and poorly interoperable ecosystem. An essential first step to facilitate this integration will be to increase the number of educational, awareness-raising and information initiatives for the stakeholders concerned. Several other recommendations were put forward to support the implementation of EUDAMED and the UDI system in France and thus enable their promises to crystallise in the future.

Case distribution and complications of mid-urethral sling surgery in a Canadian city before and after the Health Canada advisory on pelvic floor mesh.

INTRODUCTION AND HYPOTHESIS: Increased incidences of complications related to the use of mid-urethral slings (MUS) for the treatment of stress urinary incontinence resulted in both the Food and Drug Administration (FDA) and Health Canada issuing advisories in 2008 and 2010 respectively. The purpose of this study was to assess the effect these advisories had on the number of surgeons performing MUS surgery and post-surgical complications in Calgary, Canada. METHODS: In this study, we conducted a retrospective analysis of administrative data between 2006 and 2011. Post-surgical complications were identified using diagnostic codes. All rates were adjusted for the increase in the female population in Calgary during the study period. An interrupted time series model was used to evaluate any changes in the number of surgeons performing MUS surgery and any post-surgical changes from the period before and that after the advisories. RESULTS: The number of surgeons performing MUS surgery and the number of surgeries performed decreased over the study period, although neither of these was significantly related to the advisories. In terms of complications, we did not observe a significant change in the rate of repeat MUS surgeries, inpatient admissions, emergency department visits, or ambulatory care visits within 2 years of initial surgery. CONCLUSION: The FDA and Health Canada advisories had no effect on the use of MUS in Calgary. This suggests either that they bear little influence on local surgeons' practices, or that safety was already at such a high level that improvements were not possible.

UK medicines regulation: responding to current challenges.

The medicines regulatory environment is evolving rapidly in response to the changing environment. Advances in science and technology have led to a vast field of increasingly complicated pharmaceutical and medical device products; increasing globalization of the pharmaceutical industry, advances in digital technology and the internet, changing patient populations, and shifts in society also affect the regulatory environment. In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices and blood products to protect and improve public health, and supports innovation through scientific research and development. It works closely with other bodies in a single medicines network across Europe and takes forward UK health priorities. This paper discusses the range of initiatives in the UK and across Europe to support innovation in medicines regulation. The MHRA leads a number of initiatives, such as the Innovation Office, which helps innovators to navigate the regulatory processes to progress their products or technologies; and simplification of the Clinical Trials Regulations and the Early Access to Medicines Scheme, to bring innovative medicines to patients faster. The Accelerated Access Review will identify reforms to accelerate access for National Health Service patients to innovative medicines and medical technologies. PRIME and Adaptive Pathways initiatives are joint endeavours within the European regulatory community. The MHRA runs spontaneous reporting schemes and works with INTERPOL to tackle counterfeiting and substandard products sold via the internet. The role of the regulator is changing rapidly, with new risk-proportionate, flexible approaches being introduced. International collaboration is a key element of the work of regulators, and is set to expand.

A study of medical device regulation management model in Asia.

INTRODUCTION: With the aging of the post-war baby boomer generation, the increasing demands for healthcare are driving the growth of medical industry and development of new products in order to meet the immense needs from the aging population. However, medical devices are designed to maintain the health and safety of people, therefore, medical devices are undergoing rigorous management by competent health authorities in all countries. In recent years, Asian countries have been reforming their regulations and standards for medical devices with substantial changes. AREAS COVERED: The study is a summary of the framework of medical device regulations in Asian countries, including Asian Harmonization Working Party (AHWP), Japan, China, Taiwan, South Korea, India and Singapore. Expert commentary: Asian countries are constantly reforming their medical device regulations. The emergence of brand-new technology and quality management issues arose by global manufacturing have imposed difficulties in harmonizing and reaching consensus between countries. The third-party conformity assessment system for medical devices can reduce the costs for competent health authorities and shorten the review time, which could facilitate the feasibility of harmonization of medical device regulations.

The practices of do-it-yourself brain stimulation: implications for ethical considerations and regulatory proposals.

Scientists and neuroethicists have recently drawn attention to the ethical and regulatory issues surrounding the do-it-yourself (DIY) brain stimulation community, which comprises individuals stimulating their own brains with transcranial direct current stimulation (tDCS) for self-improvement. However, to date, existing regulatory proposals and ethical discussions have been put forth without engaging those involved in the DIY tDCS community or attempting to understand the nature of their practices. I argue that to better contend with the growing ethical and safety concerns surrounding DIY tDCS, we need to understand the practices of the community. This study presents the results of a preliminary inquiry into the DIY tDCS community, with a focus on knowledge that is formed, shared and appropriated within it. I show that when making or acquiring a device, DIYers (as some members call themselves) produce a body of knowledge that is completely separate from that of the scientific community, and share it via online forums, blogs, videos and personal communications. However, when applying tDCS, DIYers draw heavily on existing scientific knowledge, posting links to academic journal articles and scientific resources and adopting the standardised electrode placement system used by scientists. Some DIYers co-opt scientific knowledge and modify it by creating their own manuals and guides based on published papers. Finally, I explore how DIYers cope with the methodological limitations inherent in self-experimentation. I conclude by discussing how a deeper understanding of the practices of DIY tDCS has important regulatory and ethical implications.

[3D printing in health care facilities: What legislation in France?]. / L'impression 3D à l'hôpital: quelle réglementation en France ?

Health care facilities more and more use 3D printing, including making their own medical devices (MDs). However, production and marketing of MDs are regulated. The goal of our work was to clarify what is the current French regulation that should be applied concerning the production of custom-made MDs produced by 3D printing in a health care facility. MDs consist of all devices used for diagnosis, prevention, or treatment of diseases in patients. Prototypes and anatomic models are not considered as MDs and no specific laws apply to them. Cutting guides, splints, osteosynthesis plates or prosthesis are MDs. In order to become a MD manufacturer in France, a health care facility has to follow the requirements of the 93/42/CEE directive. In addition, custom-made 3D-printed MDs must follow the annex VIII of the directive. This needs the writing of a declaration of conformity and the respect of the essential requirements (proving that a MD is secure and conform to what is expected), the procedure has to be qualified, a risk analysis and a control of the biocompatibility of the material have to be fulfilled. The documents proving that these rules have been respected have to be available. Becoming a regulatory manufacturer of MD in France is possible for a health care facility but the specifications have to be respected.

How many testers are needed to assure the usability of medical devices?

Before releasing a product, manufacturers have to follow a regulatory framework and meet standards, producing reliable evidence that the device presents low levels of risk in use. There is, though, a gap between the needs of the manufacturers to conduct usability testing while managing their costs, and the requirements of authorities for representative evaluation data. A key issue here is the number of users that should complete this evaluation to provide confidence in a product's safety. This paper reviews the US FDA's indication that a sample composed of 15 participants per major group (or a minimum of 25 users) should be enough to identify 90-97% of the usability problems and argues that a more nuanced approach to determining sample size (which would also fit well with the FDA's own concerns) would be beneficial. The paper will show that there is no a priori cohort size that can guarantee a reliable assessment, a point stressed by the FDA in the appendices to its guidance, but that manufacturers can terminate the assessment when appropriate by using a specific approach - illustrated in this paper through a case study - called the 'Grounded Procedure'.

Current challenges for clinical trials of cardiovascular medical devices.

Several features of cardiovascular devices raise considerations for clinical trial conduct. Prospective, randomized, controlled trials remain the highest quality evidence for safety and effectiveness assessments, but, for instance, blinding may be challenging. In order to avoid bias and not confound data interpretation, the use of objective endpoints and blinding patients, study staff, core labs, and clinical endpoint committees to treatment assignment are helpful approaches. Anticipation of potential bias should be considered and planned for prospectively in a cardiovascular device trial. Prospective, single-arm studies (often referred to as registry studies) can provide additional data in some cases. They are subject to selection bias even when carefully designed; thus, they are generally not acceptable as the sole basis for pre-market approval of high risk cardiovascular devices. However, they complement the evidence base and fill the gaps unanswered by randomized trials. Registry studies present device safety and effectiveness in day-to-day clinical practice settings and detect rare adverse events in the post-market period. No single research design will be appropriate for every cardiovascular device or target patient population. The type of trial, appropriate control group, and optimal length of follow-up will depend on the specific device, its potential clinical benefits, the target patient population and the existence (or lack) of effective therapies, and its anticipated risks. Continued efforts on the part of investigators, the device industry, and government regulators are needed to reach the optimal approach for evaluating the safety and performance of innovative devices for the treatment of cardiovascular disease.

Swimming upstream: developing and commercializing diabetes products in a patent protected world.

Many, if not most, commercially available diabetes treatment products are protected by some form of intellectual property. This article discusses the development and commercialization of products in view of the state of intellectual property for the diabetes treatment market, with respect to possible discouragement, for some, from seeking patent protection or commercializing a new product under the belief that patent protection is either unavailable or difficult to come by, or for fear of infringing existing patents. Upon closer investigation, the evolution of technology almost always creates opportunities for new improvements, which likely can be patent protected. Furthermore, while avoiding the claims of existing patents is sometimes challenging and opinion based, and thus not a guarantee of avoiding a patent litigation, patent litigation may be delayed and is often settled early on.