Surgical devices and implants Directions

• collect and analyse patient information relating to surgical devices and implants. This will include reference data about manufacturers of devices and implants, for example batch number, serial number
• collect and analyse information regarding alternative procedures for the same medical conditions which do not result in a surgical device or implant, in order to enable comparison of patient outcomes associated with surgical devices and implants an alternative procedure is any procedure undertaken that did not involve a surgical device or implant which was carried out as an alternative to a procedure involving a surgical device or implant, for example use of a Coronary Artery Bypass Graft (CABG) instead of a coronary angioplasty involving an insertion of a stent
• trace NHS numbers, where not available, and where possible to trace for those patients whose NHS number was not initially supplied to allow unique identification and linkage 
• track latest known patient address in the event of a product failure 
• monitor the outcomes achieved by ‘brand’ of device or implant, hospital and surgeon, and highlight where these fall below an expected performance in order to allow prompt investigation and to support

Sections 254(1), (2)(b), (5) and (6), 304 (9),(10) and (12), 260(2)(d), 261(1)(2)(e), (3)(a),(4)  of the Health and Social Care Act  2012 (the Act) and Regulation 32 of the National Institute for Health and Social Care Excellence (Constitution and Functions) and the Health and Social Care Information Centre (Functions) Regulations 2013.

This Direction comes into force on 13 July 2020.