Informed consent and compulsory medical device registries: ethics and opportunities

2021 ◽  
pp. medethics-2020-107031
Author(s):  
Daniel B. Kramer ◽  
Efthimios Parasidis
Keyword(s):  
Informed Consent ◽  
High Risk ◽  
Medical Device ◽  
Clinical Evaluation ◽  
Medical Devices ◽  
Marketing Approval ◽  
Legal Requirements ◽  
Ethical Obligation ◽  
Cardiovascular Devices ◽  
The Usa

Many high-risk medical devices earn US marketing approval based on limited premarket clinical evaluation that leaves important questions unanswered. Rigorous postmarket surveillance includes registries that actively collect and maintain information defined by individual patient exposures to particular devices. Several prominent registries for cardiovascular devices require enrolment as a condition of reimbursement for the implant procedure, without informed consent. In this article, we focus on whether these registries, separate from their legal requirements, have an ethical obligation to obtain informed consent from enrolees, what is lost in not doing so, and the ways in which seeking and obtaining consent might strengthen postmarket surveillance in the USA.

The Medical Device Regulation of the European Union Intensifies Focus on Clinical Benefits of Devices

2019 ◽  
pp. 216847901987073 ◽  
Author(s):  
Beata Wilkinson ◽  
Robert van Boxtel
Keyword(s):  
European Union ◽  
Medical Device ◽  
Clinical Evaluation ◽  
Medical Devices ◽  
Real World ◽  
The European Union ◽  
Clinical Investigations ◽  
Clinical Benefits ◽  
The Eu ◽  
Medical Device Regulation

This article comments on the new approach to the clinical evaluation of medical devices in the European Union (EU), which adds consideration of intended clinical benefits to the traditional focus on safety and performance. The article also discusses types of clinical benefits that may be claimed and how evidence for them may be generated. In the EU, determining the benefit-risk profile is an existing core requirement of the clinical evaluation performed according to MEDDEV 2.7/1 Rev 4 guidelines, but under the new Medical Device Regulation (MDR), “intended” clinical benefits must be determined first. The MDR sets high standards for ensuring reliable data are generated from clinical investigations. It stipulates that the endpoints of clinical investigations should include clinical benefits. However, many clinical-use questions arise only after a device is made widely available to patients. For all medical devices, particularly for on-the-market devices never subjected to randomized controlled trials and for new devices developed when these trials were inappropriate/impossible, the postmarket phase of the device is a valuable source of clinical-benefit data. Postmarket clinical follow-up can corroborate and refine predictions of clinical benefits over time. Indirect clinical effects, which may affect treatment adherence and influence patients’ well-being, may surface in the postmarket phase. Real-world clinical data will improve the manufacturer’s understanding of their device’s clinical benefits, potentially changing claims of intended clinical benefits in subsequent clinical evaluations. A paradigm change in clinical evaluation of medical devices in the EU will ensue when manufacturers ensure that their devices deliver real-world clinical benefits.

Regulation of Medical Devices and their Clinical Trials Studies in the USA: An Update

2020 ◽  
Vol 13 (2) ◽  
pp. 94-109
Author(s):  
Manita ◽  
Aakash Deep ◽  
Vikram ◽  
A.C. Rana ◽  
Monu Yadav ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Medical Device ◽  
Medical Devices ◽  
Clinical Studies ◽  
Healthcare Sector ◽  
Regulatory Body ◽  
Class Iii ◽  
General Control ◽  
Dental Floss ◽  
The Usa

Background: Need for Medical devices is very important in the healthcare sector and related processes for global regulation. Medical devices are the apparatus or instruments which are specifically used for diagnostics and therapeutic applications. In the USA, a regulatory body known as FDA (Food and Drug Administration) has its unit called CDRH which looks the manufacture, packaging and use of medical devices in the USA. Objective: In USA, Medical devices are classified into 3 classes: class I which look for the medical devices used for the general control as dental floss and bandages, etc., class II which regulate the medical devices used for the general control as well as special control as powered wheelchairs and pregnancy kits. Class III medical devices look the general control. PMA (Premarket Approval) and Premarket Notification application has been filed to FDA for seeking the market authorization of medical devices. We perform clinical trials for medical device which are quite different from the clinical trials performed for drug analysis. These trials are performed on various age groups such as on paediatrics, adult and old age group commonly called phase 1,2,3,4. Regulatory approval of high-risk medical device is based on clinical studies submitted with pre-market approval. The main objective of this article is to make the researcher aware of the regulation and clinical trials of medical devices in the USA. Conclusion: Every medical device should comply with FDA, QMS and QSR for marketing in the USA. The present article has focused on the regulation of medical devices, clinical trial phases and clinical studies on medical devices.

The frequency, types and causes of medical device-related errors reported in the literature: a Rapid Review (Preprint)

2020 ◽  
Author(s):  
Emilia Anderson ◽  
Simon Poon ◽  
Jonathan Penm
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Improve Patient Safety ◽  
Near Miss ◽  
Rapid Review ◽  
Future Research ◽  
Surgical Equipment ◽  
Cardiovascular Devices ◽  
Automated External Defibrillators ◽  
Design Error

BACKGROUND The use of medical devices is rapidly expanding. Despite this, there is a huge gap in the literature surrounding the use of devices in healthcare and the adverse events occurring. Given that these errors can be life-threatening, it is imperative to have a thorough understanding of the problem in order to improve patient safety. OBJECTIVE To conduct a Rapid Review to identify the frequency, types and causes of medical device-related errors which are reported in published peer-reviewed literature. METHODS Following PRISMA guidelines, a literature search strategy was developed. Databases searched until 23 February 2018 included Pubmed, International Pharmaceutical Abstracts and Cinahl. Articles were included if they: defined medical devices, reported the frequency, causes and types of errors, were published in peer-reviewed literature. Articles were screened and discussed by two authors. RESULTS Database searching yielded 7,559 unduplicated articles. After two rounds of screening, 24 articles were included in the Review. Device types included cochlear implants, defibrillator leads, anaesthetic & intensive care devices, surgical equipment, automated external defibrillators, radiation oncology devices, ambulance stretchers, breast pumps, cardiovascular devices, orthopaedic devices, and patient controlled analgesia devices. The frequency of errors was 3.83-33.0%. The most common causes were user error, malfunction and design error. CONCLUSIONS This Review identified a range of device types associated with errors. The frequency of errors was lower than published literature. User error was confirmed as a leading cause, alongside malfunction and design error. Future research should examine near-miss events and expand the device types studied.

Trends in software as a medical device (Preprint)

2020 ◽  
Author(s):  
Aaron Ceross ◽  
Jeroen Bergmann
Keyword(s):  
Health Care ◽  
Data Analysis ◽  
High Risk ◽  
Adverse Events ◽  
Medical Device ◽  
Empirical Analysis ◽  
Medical Devices ◽  
Digital Revolution ◽  
The Us ◽  
Software Registration

UNSTRUCTURED Software-as-a-medical-device (SaMD) has gained popularity as a type of medical device. However, to date, empirical analysis of SaMD trends have been lacking. Using databases managed by the US medical device regulator (the Food and Drug Administration), we map the path SaMD takes towards classification and recorded adverse events. The findings show that while SaMD has been identified in literature as an area of development, the data analysis suggests that this growth has been modest. These devices are overwhelming classified as moderate to high risk and they take a very particular path to that classification. The digital revolution in health care is less pronounced when evidence is considered of SaMD. In general, the trend for software registration mimics that of medical devices.

scholarly journals Did the Individual Consent to the Risk of Harm? A Comparative Jurisdictional Analysis of Consent in Cases of Sexual Transmission/Exposure to HIV

2018 ◽  
Vol 82 (1) ◽  
pp. 76-105
Author(s):  
David Hughes
Keyword(s):  
Informed Consent ◽  
High Risk ◽  
Sexual Intercourse ◽  
Sexual Transmission ◽  
Unprotected Sexual Intercourse ◽  
Hiv Virus ◽  
The Usa ◽  
Legislative Framework ◽  
Consent Requirement ◽  
The Individual

This article considers the necessary ingredients for an individual to consent to running the risk of the HIV virus being transmitted through high-risk unprotected sexual intercourse. In order to achieve this aim, an assessment of what should equate to a fully informed consent is evaluated. The article will provide a comparative jurisdictional analysis of the consent requirement in three particularised jurisdictions: England, Canada and the USA. A comparison of relational judicial precepts will follow the discussion of extant law in each country. It will be established that few jurisdictions fully consider the requirements of a fully informed consent. The final part of the article will suggest a bespoke new legislative framework that will account for the circumstances that are necessary for an individual to provide a fully informed consent to the risk of acquiring the virus.

Physician-Developer Interaction in Medical Device Design

2010 ◽  
Author(s):  
Lauren A. Shluzas ◽  
Larry J. Leifer
Keyword(s):  
High Risk ◽  
Medical Device ◽  
Medical Devices ◽  
Early Stage ◽  
End Users ◽  
Device Design ◽  
Financial Outcomes ◽  
Medical Device Design ◽  
Medical Products

Industry-physician relationships have been widely reported throughout the medical device community. However, there is limited research that describes how device developers effectively interact with physicians throughout the development of new medical products. There is also limited research regarding how the process of physician-developer interaction influences the clinical and financial outcomes of early stage companies. Knowledge of such interaction is particularly relevant to the large and growing number of complex and high-risk medical devices, in which physicians are the primary end users and patients are the recipients of care.

scholarly journals Improved clinical investigation and evaluation of high-risk medical devices: the rationale and objectives of CORE-MD (Coordinating Research and Evidence for Medical Devices)

2021 ◽  
Author(s):  
A G Fraser ◽  
R G H H Nelissen ◽  
P Kjærsgaard-Andersen ◽  
P Szymański ◽  
T Melvin ◽  
...  
Keyword(s):  
High Risk ◽  
Medical Device ◽  
Medical Devices ◽  
Real World ◽  
Clinical Investigation ◽  
Pharmaceutical Products ◽  
European Medicines Agency ◽  
European Federation ◽  
The European Union ◽  
Clinical Investigations

Abstract In the European Union (EU) the delivery of health services is a national responsibility but there are concerted actions between member states to protect public health. Approval of pharmaceutical products is the responsibility of the European Medicines Agency, whereas authorizing the placing on the market of medical devices is decentralized to independent ‘conformity assessment’ organizations called notified bodies. The first legal basis for an EU system of evaluating medical devices and approving their market access was the medical device directives, from the 1990s. Uncertainties about clinical evidence requirements, among other reasons, led to the EU Medical Device Regulation (2017/745) that has applied since May 2021. It provides general principles for clinical investigations but few methodological details—which challenges responsible authorities to set appropriate balances between regulation and innovation, pre- and post-market studies, and clinical trials and real-world evidence. Scientific experts should advise on methods and standards for assessing and approving new high-risk devices, and safety, efficacy, and transparency of evidence should be paramount. The European Commission recently awarded a Horizon 2020 grant to a consortium led by the European Society of Cardiology and the European Federation of National Associations of Orthopaedics and Traumatology, that will review methodologies of clinical investigations, advise on study designs, and develop recommendations for aggregating clinical data from registries and other real-world sources. The CORE-MD project (Coordinating Research and Evidence for Medical Devices) will run until March 2024; here we describe how it may contribute to the development of regulatory science in Europe.

scholarly journals Pattern of Medical Device Adverse Events in a Tertiary Level Hospital in Northern India: An Ambispective Study

2021 ◽  
Author(s):  
Saifuddin PK ◽  
Ajay Prakash ◽  
Ram Samujh ◽  
SK Gupta ◽  
Vanita Suri ◽  
...  
Keyword(s):  
Retrospective Study ◽  
High Risk ◽  
Adverse Events ◽  
Prospective Study ◽  
Medical Device ◽  
Medical Devices ◽  
Tertiary Level ◽  
Risk Class ◽  
Northern India ◽  
Class B

Abstract Background: This is the first study to evaluate the pattern of adverse events related to medical devices in India. We aimed to evaluate medical device adverse events (MDAEs) reported at a tertiary level teaching hospital in northern India.Methods: This descriptive study was conducted ambispectively at PGIMER, Chandigarh. We used the medical device risk classification given by the Indian regulatory authority which was framed in line with the recommendation of the Global Harmonization Task Force. The prospective study (PS) was done from January 2020 to December 2020 with a concurrent retrospective study (RS) proceeding to three years so as to learn more about the reporting culture, demographics, risk class of devices and the type of adverse events.Result. We obtained 224 MDAE in the prospective study and identified 413 MDAE in retrospective study. Reporting culture of retrospective adverse events to the national materiovigilance programme of India (MvPI) was negligible. Marginally increased incidence of MDAE reported among male patients (PS; 52%, RS; 57%) and age group between 21-30 years (PS; 19.1%, RS; 23.2%) in both studies. Fewer number of MDAEs were also reported from infants (7.5%) and the elderly (6.9%) population. Regarding risk class, MDAEs were frequent in low to moderate risk devices (Class B: 66%) in the prospective study, while it was documented only for high-risk devices (Class C: 51% & Class D: 49%) in the retrospective study. However, serious adverse events (SAEs) were equally prevalent among moderate to high-risk devices (Class B: 33%, C: 34% &D: 33%). An increased frequency of SAE was observed among non-notified medical devices (60.4%). Concerning reporting culture, nurses reported the majority of MDAEs (65%). Overall 14% of the incidents were documented as near-miss events.Conclusion: Medical devices elicit adverse events irrespective of their risk class, notification status and patient demographic factors. Escalated reporting of MDAEs by surgeons and biomedical engineers is recommended at India.

scholarly journals Improved clinical investigation and evaluation of high-risk medical devices: the rationale and objectives of CORE–MD (Coordinating Research and Evidence for Medical Devices)

2021 ◽  
Vol 6 (10) ◽  
pp. 839-849
Author(s):  
Alan G. Fraser ◽  
Rob G.H.H. Nelissen ◽  
Per Kjærsgaard-Andersen ◽  
Piotr Szymański ◽  
Tom Melvin ◽  
...  
Keyword(s):  
High Risk ◽  
Medical Device ◽  
Medical Devices ◽  
Real World ◽  
Clinical Investigation ◽  
Pharmaceutical Products ◽  
European Medicines Agency ◽  
European Federation ◽  
The European Union ◽  
Clinical Investigations

In the European Union (EU), the delivery of health services is a national responsibility but there are concerted actions between member states to protect public health. Approval of pharmaceutical products is the responsibility of the European Medicines Agency, while authorising the placing on the market of medical devices is decentralised to independent ‘conformity assessment’ organisations called notified bodies. The first legal basis for an EU system of evaluating medical devices and approving their market access was the Medical Device Directive, from the 1990s. Uncertainties about clinical evidence requirements, among other reasons, led to the EU Medical Device Regulation (2017/745) that has applied since May 2021. It provides general principles for clinical investigations but few methodological details – which challenges responsible authorities to set appropriate balances between regulation and innovation, pre- and post-market studies, and clinical trials and real-world evidence. Scientific experts should advise on methods and standards for assessing and approving new high-risk devices, and safety, efficacy, and transparency of evidence should be paramount. The European Commission recently awarded a Horizon 2020 grant to a consortium led by the European Society of Cardiology and the European Federation of National Associations of Orthopaedics and Traumatology, that will review methodologies of clinical investigations, advise on study designs, and develop recommendations for aggregating clinical data from registries and other real-world sources. The CORE–MD project (Coordinating Research and Evidence for Medical Devices) will run until March 2024. Here, we describe how it may contribute to the development of regulatory science in Europe. Cite this article: EFORT Open Rev 2021;6:839-849. DOI: 10.1302/2058-5241.6.210081

scholarly journals Registration, Publication, and Outcome Reporting among Pivotal Clinical Trials that Supported FDA Approval of High-Risk Medical Devices Before and After FDAAA

2021 ◽  
Author(s):  
Matthew J. Swanson ◽  
James L. Johnston ◽  
Joseph S. Ross
Keyword(s):  
Clinical Trials ◽  
High Risk ◽  
Medical Devices ◽  
Primary Efficacy ◽  
Cardiovascular Devices ◽  
Primary Efficacy Outcome ◽  
Outcome Reporting ◽  
Fda Approval ◽  
Efficacy Outcome ◽  
Before And After

ABSTRACTBackgroundSelective registration, publication, and outcome reporting of clinical trials distorts the primary clinical evidence that is available to patients and clinicians regarding the safety and efficacy of FDA-approved medical devices. The purpose of this study is to compare registration, publication, and outcome reporting among pivotal clinical trials that supported FDA approval of high-risk (Class III) medical devices before and after the U.S. Food and Drug Administration (FDA) Amendment Act (FDAAA) was enacted in 2007.MethodsUsing publicly available data from ClinicalTrials.gov, FDA summaries, and PubMed, we determined registration, publication, and reporting of findings for all pivotal clinical studies supporting FDA approval of new high-risk cardiovascular devices between 2005 and 2020, before and after FDAAA. For published studies, we compared both the primary efficacy outcome with the PMA primary efficacy outcome and the published interpretation of findings with the FDA reviewer’s interpretation (positive, equivocal, or negative).ResultsBetween 2005 and 2020, the FDA approved 156 high-risk cardiovascular devices on the basis of 165 pivotal trials, 48 (29%) of which were categorized as pre-FDAAA and 117 (71%) as post-FDAAA. Post-FDAAA, pivotal clinical trials were more likely to be registered (115 of 117 (98%) vs 24 of 48 (50%); p < 0.001), to report results (98 of 115 (85%) vs 7 of 24 (29%); p < 0.001) on ClinicalTrials.gov, and to be published (100 or 117 (85%) vs 28 of 48 (58%); p < 0.001) in peer-reviewed literature when compared to pre-FDAAA. Among published trials, rates of concordant primary efficacy outcome reporting were not significantly different between pre-FDAAA trials and post-FDAAA trials (24 of 28 (86%) vs 96 of 100 (96%); p = 0.07), nor were rates of concordant trial interpretation (27 of 28 (96%) vs 93 of 100 (93%); p = 0.44).ConclusionsFDAAA was associated with increased registration, results reporting, and publication for trials supporting FDA approval of high-risk medical devices. Among published trials, rates of accurate primary efficacy outcome reporting and trial interpretation were high and no different post-FDAAA.

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