Dáil Éireann Debate, Tuesday - 26 April 2022
1493. Deputy David Cullinane asked the Minister for Health the number of notifications that have been made to the Health Products Regulatory Authority in regard to defective devices used by treating surgeons to date; and if he will make a statement on the matter. [19845/22]
View answerWithin the medical device framework, the Heath Products Regulatory Authority (HPRA) does not approve or certify medical devices for sale in Ireland or any other country. Medical devices placed on the Irish or European market must conform to the requirements of the relevant European legislation. These require that medical devices perform safely while achieving the purpose intended by the medical device manufacturer. In its role as market surveillance authority, the HPRA monitors the safety of medical devices after they are placed on the Irish market.
The aim of the medical devices vigilance system is to reduce the 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 serious incidents and field safety corrective actions associated with medical devices. With respect to incident reporting, please note that while there is no mandatory reporting requirement for users, patients, care-givers and healthcare professionals, the HPRA strongly encourages all relevant stakeholders, including those already listed, to report any safety issues they have experienced with a medical device. Manufacturers are required to submit medical device serious incident reports to the HPRA within specified reporting timelines outlined in the legislation.
The HPRA has an ongoing market surveillance review related to the safety and performance of the MAGEC Spinal System, elements of which have been carried out in conjunction with the UK MHRA. As part of the review, the HPRA has carried out an assessment of the technical documentation related to the device. Implantation of MAGEC rods remains on hold in Ireland since April 2020 following issuance of a manufacturer field safety notice by the manufacturer, NuVasive Specialized Orthopaedics (NSO). HPRA continues to assess information provided by the manufacturer and other stakeholders in relation to suspected adverse events and risk assessment reports, among other documentation, to determine whether the benefits of using these devices outweigh the known and potential risks. As part of this ongoing review, the HPRA has liaised with relevant stakeholders including healthcare professionals who use this device and a patient advocacy group.
The HPRA has confirmed to the Department that it has received no reports from healthcare professionals regarding individual cases of defective devices in Ireland, however the HPRA has engaged with healthcare professionals in Ireland who use these devices as part of our ongoing market surveillance activities.
