Patients and healthcare professionals’ perspective on medical devices

Abstract

Medical devices are part of an armamentarium that is required to provide best possible care to patients. They form a crucial part of healthcare delivery, ranging from simple aids such as bandages and glucometers to more complex technologies including pacemakers and MRI scanners. Despite strengthened EU regulations (MDR/IVDR), awareness and perceptions amongst patients and healthcare professionals show significant gaps, necessitating further efforts to bridge them. This study aims to capture the perception and awareness of the Maltese healthcare professionals, patients and medical device industry stakeholders in relation to medical devices in the light of the EU Regulation 2017/745 and EU Regulation 2017/746. A literature review was carried out to identify tools required to assess the perception of medical devices by different users including economic operators such as manufacturers, healthcare providers and patients. Study findings led to the development and validation of two separate questionnaires namely i) ‘General Public awareness and perception questionnaire’ intended for the general public who used medical devices and the ii) ‘Healthcare professionals and economic operators’ awareness and perception questionnaire’ intended for healthcare professionals dealing with medical devices. Ethics approval was granted. Both questionnaires, which were anonymous, were validated by an expert panel. The ‘General Public awareness and perception questionnaire’ was distributed in 3 community pharmacies chosen by convenience sampling. Patients aged over 18 years of age, who did not suffer from mental health problems and, or dementia and who were using medical devices were approached by the community pharmacist who acted as the intermediary. The ‘Healthcare professionals and economic operators’ awareness and perception questionnaire’ was electronically distributed via the Superintendent of Public Health. Patient paper responses were manually entered by the researcher. Data were analysed descriptively, with thematic coding of qualitative responses. Seventy-five patients and seventy-five healthcare professionals and economic completed the questionnaires respectively. Among patients, 37 reported complications, mainly misuse or device malfunction. The majority of the patients (n=73) felt that medical devices improved their quality of life and way of coping with medical conditions. Training about handling devices amongst the general public was inconsistent with 33 patients claiming of receiving none. Healthcare professionals reported higher confidence (n=65 comfortable or very comfortable in device use). About 10 healthcare professionals claimed to be unsure about reporting procedures for incident reporting. Interest in further training was strong, with 66 healthcare professionals supporting structured training programmes. While both groups value medical devices, gaps in training and reporting persist. Strengthening pharmacist-led education and embedding reporting culture are key to improving safe and effective medical device use in Malta.