Dáil Éireann Debate, Thursday - 16 June 2022
511. Deputy David Cullinane asked the Minister for Health if any contraction of a hospital acquired infection was confirmed as a result of a reusable invasive medical device; and if he will make a statement on the matter. [31673/22]
View answerA medical device is a health product or piece of equipment used for a medical purpose to diagnose, monitor, or treat illness or disease and to assist people with physical impairments. Examples include plasters and bandages, wheelchairs, contact lenses, blood pressure meters, ventilators, incubators, hip implants, coronary stents, pacemakers, and defibrillators.
In the EU, medical devices are regulated by way of an EU wide framework which aims to ensure that all medical devices available for use on the EU market are safe and perform as intended. A valid medical device bears a ‘CE’ mark, which indicates that it meets the basic requirements for safety and effectiveness under European law and can be placed on the EU market.
In Ireland, the Health Products Regulatory Authority (HPRA) is the competent authority for medical devices and their role includes enforcing the applicable legislation and monitoring the safety of medical devices after they are placed on the market.
As such, the HPRA undertakes many functions, including, but not limited to, designating notified bodies within the jurisdiction, assessing clinical investigations of medical devices, and undertaking vigilance and market surveillance for medical devices. The aim of the vigilance system is to reduce a risk of death or serious deterioration in the state of health associated with the use of a medical device that is already placed on the market. Within this context, the HPRA evaluates specific incidents and field safety corrective actions associated with medical devices including events which relate to reusable invasive medical devices . However the HPRA does not monitor rates of hospital acquired infections.
To answer the specific query it would be most helpful if the Deputy could provide further information such as, a specific incident being referenced, or total number of reports the HPRA may have received for a specific type of device, to assist in providing a more detailed response.
