Regulation of medical devices

Abstract

Ranging from simple tongue depressors to heart valves and robotic surgery systems, medical devices are essential in the healthcare sector providing numerous benefits to the patient. Two new regulations from the European Commission, medical devices (MD) and in-vitro MD will come into force in May 2021 and May 2022 respectively. The study on medical devices could shed light on current practices in Malta and recommend improvements before the full implementation of the European Regulation on MD. The purpose of the study is (1) to set-up a MD database (DB) and (2) to improve the current incident reporting system for MD in the national healthcare system. The research, a prospective and interventional study, is divided into two sections. Section 1: Setting up of a MD database for the national competent authority (NCA). A review of the systems used by NCAs throughout the EU/EEA was conducted by contacting the MD competent authorities individually. The systems used throughout the EU/EEA were discussed in Focus Group A consisting of regulatory experts during which recommendations for the setup of MD DB were drawn up. The responses (n=12; 54.5%) from the European NCAs together with the recommendations resulting from the Focus Group A session were used to device the framework of (i) a DB for the registration of an entity and (ii) a DB for the registration of MD. Section 2: Analysis and update of the current incident reporting system for medical devices. Incident reports submitted at the national healthcare system by healthcare professionals (HCPs) in 2019 were collated in a database and analysed. Focus Group B, consisting of different experts, was set up to provide recommendations for the development of an improved incident reporting system. A total of 107 incidents originating from local hospitals (n=103; 96.3%), Pharmacy of your Choice Scheme (n=3; 2.8%), health centres (n=1; 0.9%) were submitted. Injury to patient/ operator was reported in 18 cases (16.8%). The most common types of MD reported in incidents were General and Plastic Surgery devices (n=48; 44.9%) and General Hospital Devices (n=22; 20.6%). Underreporting of MD incidents was identified. Barriers to MD incident reporting identified during Focus Group B include attitudes of HCPs, blame culture, legal liability, deficiencies in the MD procurement process, lack of training and education on MD incidents, recognition of MD incidents and deficiencies in the current reporting form. The results from Section 2 were used to propose a new Medical Device Incident Reporting Form (MDIRF). The areas identified for improvement in the new form were the addition of sections for (i) combination products, (ii) details on sample retention and (iii) addition of details for the description of injuries. Results from Focus Group A and responses from other NCAs indicated that a MD DB is crucial as part of the regulatory framework for MD. The results have shown that there is a low reporting of MD incidents (N=108 reports in 2019) and changes to the current system are warranted. Strengthening a safety culture based on lessons learnt and education between HCPs, in the context of MD incident reporting is proposed to improve patient and user safety.