Evaluating the Safety Profile of Non-Active Implantable Medical Devices Compared with Medicines

Abstract

Recent safety issues involving non-active implantable medical devices (NAIMDs) have highlighted the need for better pre-market and post-market evaluation. Some stakeholders have argued that certain features of medicine safety evaluation should also be applied to medical devices. Our objectives were to compare the current processes and methodologies for the assessment of NAIMD safety profiles with those for medicines, identify potential gaps, and make recommendations for the adoption of new methodologies for the ongoing benefit–risk monitoring of these devices throughout their entire life cycle. A literature review served to examine the current tools for the safety evaluation of NAIMDs and those for medicines. We searched MEDLINE using these two categories. We supplemented this search with Google searches using the same key terms used in the MEDLINE search. Using a comparative approach, we summarized the new product design, development cycle (preclinical and clinical phases), and post-market phases for NAIMDs and drugs. We also evaluated and compared the respective processes to integrate and assess safety data during the life cycle of the products, including signal detection, signal management, and subsequent potential regulatory actions. The search identified a gap in NAIMD safety signal generation: no global program exists that collects and analyzes adverse events and product quality issues. Data sources in real-world settings, such as electronic health records, need to be effectively identified and explored as additional sources of safety information, particularly in some areas such as the EU and USA where there are plans to implement the unique device identifier (UDI). The UDI and other initiatives will enable more robust follow-up and assessment of long-term patient outcomes. The safety evaluation system for NAIMDs differs in many ways from those for drugs, but both systems face analogous challenges with respect to monitoring real-world usage. Certain features of the drug safety evaluation process could, if adopted and adapted for NAIMDs, lead to better and more systematic evaluations of the latter.

EU postmarket surveillance plans for medical devices

“…Today, many medical device manufacturers have a “reactive” PMS system that is based on the collection of postmarket data received from spontaneous reporting of complaints and incidents. Unfortunately, there are few proactive PMS processes designed to actively gain knowledge on the safety and performance of the medical device through external sources like registries, electronic healthcare records, safety evaluation sites, claim databases, social networks, and literature …”

“…Unfortunately, there are few proactive PMS processes designed to actively gain knowledge on the safety and performance of the medical device through external sources like registries, electronic healthcare records, safety evaluation sites, claim databases, social networks, and literature. 8 The new EU Regulation aims to reinforce key elements of the existing regulatory approach, including vigilance and market surveillance, at the same time ensuring transparency and traceability, to improve health and safety. 5 The objective of this article is to describe the new EU Regulation on PMS of medical devices, to compare it with our experience in the drug area, and to provide recommendations for implementation.…”

Medical device active surveillance of spontaneous reports: A literature review of signal detection methods

“…Device alone (n = 8, 8%) is defined as a study examining outcomes for specific device(s) or device class(es). The PV category is assigned to PV articles, while the Safety category was created for Pane's review of safety evaluation approaches for implantable medical devices …”

“…Third, there is little published literature on handling known signaling factors when performing MDV. These factors include learning curves, user errors, and device design changes . Furthermore, medical devices encompass an extremely diverse range of products.…”

Descriptive analysis of postmarket surveillance data for hip implants

“…Given the large use of hip implants and the need to improve medical device vigilance, we performed a case study and conducted a descriptive analysis of the PMS data from one of the most important publicly available spontaneous reports database, the Food and Drug Administration's (FDA) Manufacturer and User Facility Device Experience (MAUDE) database, to assess the quality and the quantity of these spontaneous reports using hip implants as a proof of concept, but our aim was not to investigate and compare the safety of individual (or specific) implants.…”