NHSE begins rollout of mandatory outcomes registry
Trusts must start submitting full data on surgeries which include a high-risk medical device into a new national registry by December as part of a national push to increase accountability and safety around surgery.
NHS England is launching the new mandatory medical device outcome registry this month. The new registry was created in response to Baroness Cumberlege’s “First Do No Harm” review and initial data submissions about surgeries that include a high-risk medical device will begin in June.
Details of the launch arrangements have been set out in a draft letter which HSJ has seen and understands is set to be sent to medical directors and other system leaders imminently.
Relevant procedures include those, for example, involving either a Class III device, like an implant, or a Class IIb therapeutic device, such as drug-eluting balloon catheter.
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Source: HSJ, 16 May 2023