The HPRA has been working closely with medical device users in hospitals and community settings to drive quality improvement in medical device safety. The approach has focused on three inter-related areas:
- the dissemination of safety information
- the development of the role of ‘designated person / vigilance officer’
- the encouragement of user reporting.
In relation to the dissemination of safety information, the Health Services Executive (HSE) has developed a National Medical Device eAlert System designed to streamline the management of the HPRA medical devices safety notices within the public health system. As the national competent authority for medical devices, the HPRA publishes safety notices highlighting safety concerns related to medical devices. Healthcare professionals and institutions also receive our safety notices through a direct email.
Please note that the HPRA also publish information notices. The aim of these communications is to highlight specific aspects of medical devices legislation.
A pivotal part of the success of the eAlert system is the nomination of a ‘designated person / vigilance officer’ within hospitals and other health facilities to take responsibility for the receipt of the medical device alert notifications. The ‘designated person / vigilance officer’ will ensure the further internal facility distribution to the relevant personnel for implementation of the recommended actions where applicable.
To assist in the encouragement of user reporting of medical device adverse events, the HPRA, together with the HSE, also developed a Step-by Step Guide, detailing when and how to report a medical device adverse incident.