MHRA news: Committee on the Safety of Devices (CSD) now Devices Expert Advisory Committee (DEAC), has new chair

The Medicines and Healthcare products Regulatory Agency (MHRA) has appointed a chair to its recently created Devices Expert Advisory Committee (DEAC) which replaces the Committee on the Safety of Devices (CSD). The creation of the new DEAC was announced on 18 July 2014 in response to one of 12 suggestions*, by Prof Terence Stephenson, who was asked by the MHRA “to lead an independent review into how the MHRA can improve its access to clinical advice and engagement with the clinical community in relation to medical devices.”

From the Medicine and Healthcare Regulatory Agency’s 18 February 2015 press release

“Dr Peter Nightingale has been appointed as chairman of the Medicines and Healthcare products Regulatory Agency’s (MHRA) Devices Expert Advisory Committee (DEAC).

The DEAC has been formed following an independent review on MHRA access to clinical advice and engagement with the clinical community. This new committee will replace the Committee on the Safety of Devices.

The new committee will be responsible for providing independent, expert strategic advice to the agency in support of its role to ensure that medical devices are acceptably safe and are used both safely and effectively.”

The 12 suggestions made by the Stephenson review

Organisation of clinical advice input, resources and leadership
1. Formal organisation of clinical advice input to MHRA
2. Review the MHRA resources needed
3. Ensure that adequate clinically trained staff are included in the MHRA staff
4. Develop and manage the network of clinical advisors
5. Develop the existing collaboration with EU bodies with similar aims to the UK MHRA

Collecting and using device incident data
6. Build links with the Clinical Commissioning Groups to improve the flow of information on the safety and performance of devices

Communications and partnerships
7. Improve and simplify the way incidents are reported, aiming to obtain reports on all device incidents
8. Develop means by which devices implanted in patients can be identified by their Unique
Device Identifiers, and means by which patients with specific devices can be traced
9. Improve communications about adverse incidents to patients and the public, clinical staff, clinical scientists, hospital managers and professional bodies
10. Develop improved and more frequent communications with clinicians, clinical scientists, hospital managers and the public
11. Develop collaboration with NICE, NHS, devolved administrations, independent sector

Future developments and emerging challenges
12. Support the safe introduction of new and innovative technologies into clinical practice

Background, context and further reading

MHRA response to the Independent Review on access to clinical advice and engagement with the clinical community in relation to medical devices (18 July 2014) MHRA – 12 recommendations made by Prof Terence Stephenson

After Weathering Scandals, UK Appoints New Medical Device Oversight Official (18 February 2015) Regulatory Affairs Professionals Society

“In 2014, an independent review of the UK’s MHRA concluded that the agency needs to bolster its oversight of medical devices and increase its engagement with the medical device clinical community.

The review, headed by Professor Terence Stephenson, chair of the UK Academy of Medical Royal Colleges, was conducted in light of recent highly publicized cases of faulty medical devices in Europe [such as breast and hip implants].”

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