January 20, 2023 Industry news
The Health and Social Care Committee issues eight recommendations in response to the Government address on the IMMDS review.
Today, Friday 20 January 2023, The Health and Social Care Committee have released a response to the Government’s response to the Independent Medicines and Medical Devices Safety Review (IMMDS review).
Published in July 2020, the IMMDS review titled First Do No Harm, made nine recommendations centred on enabling the traceability of medicines and medical devices to improve patient safety.
Since then the Government has started introducing measures to meet many of the recommendations and released a response detailing progress in December 2002.
Today’s Health and Social Care Committee report highlights eight recommendations for the Government in relation to the December announcement.
The primary point states: “[The Health and Social Care Committee] recommend that the Government urgently ensures that the accepted recommendations 6 and 7 of the IMMDS review are fully implemented.
- Recommendation 6: The Medicines and Healthcare products Regulatory Agency (MHRA) needs substantial revision particularly in relation to adverse event reporting and medical device regulation. It needs to ensure that it engages more with patients and their outcomes. It needs to raise awareness of its public protection roles and to ensure that patients have an integral role in its work.
- Recommendation 7: A central patient-identifiable database should be created by collecting key details of the implantation of all devices at the time of the operation. This can then be linked to specifically created registers to research and audit the outcomes both in terms of the device safety and patient reported outcomes measures.”
Support for the implementation of the national patient-identifiable database will be essential to allow for effective post-market surveillance once these item (medicines and medical devices) are on the market, and used in, or on, patients.
The unique identification of medicines and medical devices will be fundamental to the delivery of these two important recommendations.
