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Have your say on the NHS Digital Medical Device Information System

Date: September 08, 2021

Category: Industry news


As development of the Medical Device Information System gets underway, NHS Digital release a public consultation to gauge feedback

Background

Following the recommendations outline in Baroness Cumberlege’s Independent Medicines and Medical Device Safety Review – IMMDS Review (also known as the Cumberlege Review), The Centre have begun to implement measures to ensure the appropriate traceability of medical devices used at the point of use or care. 

“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.”

In response, NHS Digital are in the process of developing a Medical Device Information System (MDIS) designed to act as a centralised national registry to meet this requirement.

What is the MDIS?

The MDIS will serve as a patient-identifiable database designed to capture key procedural-related information gathered from healthcare provider organisations across the UK.

This will include accurate details of:

  • Medical device – the device used in the procedure (including batch, manufacturer, expiry)
  • Patient – accurate, unique, positive patient ID
  • Clinician – the clinician that performed the procedure
  • Location – details of where the procedure took place

N.B. Reference data to be captured by trusts include GS1 standards: Global Trade Item Number – GTIN, for device information, and Global Location Number – GLN, for manufacturer information.

Public consultation

As a starting point, NHS Digital are implementing a “Pelvic Floor Registry and associated information system” to “support the future development of a UK-wide Medical Devices Information System – dependent on regulations being introduced under the Medicines and Medical Devices Act.”

Open to trusts, suppliers and solution providers for completion, NHS Digital have since released a public consultation requesting feedback on the proposal. The deadline for submissions is Sunday 12 September 2021.

Supporting information to help complete the survey can be found below – “Key considerations for the consultation”.

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