Post-market surveillance of medical devices: A review

Abstract

BACKGROUND: Medical devices (MDs) represent the backbone of the modern healthcare system. Considering their importance in daily medical practice, the process of manufacturing, marketing and usage has to be regulated at all levels. Harmonized evidence-based conformity assessment of MDs during PMS relying on traceability of medical device measurements can contribute to higher reliability of MD performance and consequently to higher reliability of diagnosis and treatments. OBJECTIVE: This paper discusses issues within MD post-market surveillance (PMS) mechanisms in order to set a path to harmonization of MD PMS. METHODS: Medline (1980–2021), EBSCO (1991–2021), and PubMed (1980–2021) as well as national and international legislation and standard databases along with reference lists of eligible articles and guidelines of relevant regulatory authorities such as European Commission, Food and Drug Administration were searched for relevant information. Journal articles that contain information regarding PMS methodologies concerning stand-alone medical devices. National and international legislation, standards and guidelines concerning the topic. RESULTS: The search strategy resulted in 2282 papers. Out of those only 24 articles satisfied the eligibility criteria and were finally included in the review. Papers were grouped per categories: medical device registry, medical device adverse event reporting, and medical device performance evaluation. In addition to journal articles, national and international legislation, standards, and guidelines were reviewed to assess the state of PMS in different regions of the world. CONCLUSION: Although the regulatory framework prescribes PMS of medical devices, the process itself is not harmonized with international standards. Particularly, conformity assessment of MDs, as an important part of PMS, is not measured and managed in a traceable, evidence-based manner. The lack of harmonization within PMS results in an environment of increased adverse events involving MDs and overall mistrust in medical device diagnosis and treatment results.

A novel method for conformity assessment testing of electrocardiographs for post-market surveillance purposes

“…The novel methodology was developed based on OIML guidelines for technical and metrological characteristics and performance evaluation. Developed methodology has been validated by the work of two inspection bodies for medical devices working under the legal metrology framework which has been adopted for medical devices in Bosnia and Herzegovina and Republic of Serbia [13,14]. The introduction of standardized conformity assessment method for testing of safety and performance of ECG device produced traceable, accurate, complete, verified, nonbiased and standardized data.…”

“…Prior to its placement on the market, each ECG device is thoroughly tested and evaluated to avoid any faults in its function. However, upon market placement, the regulatory oversight is disharmonized and there are no standards indicating how it should be performed [4]. Regardless of the variations in types, all devices of this type perform the same function.…”

Evidence-based maintenance of medical devices: Current shortage and pathway towards solution

“…In the EU, the new Medical Device Regulation [14][15][16] regulates PMS more strategically with the intention to address these challenges. MDR introduces independent, third party -notified body [11] and prescribes that some of PMS activities should be performed by these bodies.…”

“…The new MDR [14][15][16] stresses a priority on continuous review of post-market issues and analysis of those issues, specifically that manufacturers should have "a post-market surveillance system in place which should be proportionate to the risk class and the type of device in question." The MDR also explicitly states that data from post-market surveillance activities should feed into multiple areas, including the riskbenefit analysis, manufacturing instructions, corrective and preventive actions, and for the identification of options to improve the usability, performance and safety of the device.…”

“…This significant drawback was recognized by the Institute of Electrical and Electronics Engineers (IEEE) standards group that began to work on harmonization of MD PMS performance evaluation within the Medical Device with Measuring Function (MDMF) group. The first standard the group is working on is P2727 -Standard for General Vocabulary for Conformity assessment testing of Medical Devices with Measuring Function [16]. The goal of this work is to link medical devices and their performance assessment testing to the metrological concepts and terms and to develop standards for conformity assessment testing of MDs.…”