Risks in medical device vigilance

Abstract

Medical devices include a variety of products ranging from simple bandages to artificial bones. Intensive safety measures are adopted from the approval up to release of the medical device to the market. The aims of the study were to 1) evaluate perspectives of end-users with medical device incident reporting, 2) assess and develop a database for medical device Compliance Exchange Form (CEF) received by the medical device directorate which contains medical device inquiries from Competent Authorities and Designating Authorities within the European Union, 3) assess procedures used by a competent authority in handling incident reports, and 4) develop a risk management plan for risk mitigation. The study employed a qualitative approach in which Phase 1 is literature analysis of end-users’ perspective with medical devices. Phase 2 dealt with the evaluation of Compliance Exchange Form received by the competent authority from 2021 to 2022 through a developed database. Phase 3 involved a gap analysis of the current Standard Operating Procedures (SOP) of a competent authority through a focus group discussion with three members representing the medical device directorate of the competent authority, and Phase 4 was the development of a risk management plan and pilot implementation. The study results were: Phase 1: From the literature review, eight barriers of underreporting in medical devices were found: Lack of awareness in reporting, workload and time constraints, incident was deemed non-reportable, perception of consequence, lack of reporting system, non-reporting culture, failure to recognise incident and blame culture. Phase 2: The assessment of the CEF showed that Malta participated and responded to six CEFs out of nine CEFs received. The CEF database showed differences in the number of initiated CEFs within EU member states which can be attributed to the accessibility and digitalisation of reporting systems. Phase 3: The three representatives of the focus group discussion identified that 1) the present SOP is adequate for operations in Malta, 2) direct communication with stakeholders improved quality of investigation, 3) triage system in receiving reports needed further development, and 4) plans for information dissemination to reduce underreporting are in place. Phase 4: A risk management plan was developed and the pilot implementation with an assessor from the medical device directorate was done. A risk score using the risk matrix was identified for each incident report and corresponding action plan was recommended for risk reduction. The incorporation of the risk management plan to the SOP of the medical device directorate contributes to the continuous efforts of medical device vigilance. Harmonisation of incident reporting and assessment of lack of reporting are recommended. Strengthening the medical device vigilance leads to improved safety of patients and medical device users.