Trialling and procurement of new medical devices

Whilst the Trust encourages new medical device innovations, it is important to remember that for patient and staff safety, any new medical device identified for trialling or purchasing must go through the correct processes before coming into the Trust.

Medical devices should not be purchased, trialled or used on our patients without following the approval process below.

In the first instance, any member of staff with an idea they would like to explore surrounding innovation of new medical devices, should email the Quality Improvement and Professional Standards team at QI@eastamb.nhs.uk  or discuss with their Area Clinical Lead who will direct them to this address.

The Quality Improvement Team will then engage and assist in navigating the governance processes which will include the Product Alignment Group, and Medical Devices Safety and Management Group. Dependent upon the associated risk, this may then be signed off clinically at either Clinical Development Effectiveness Group or Clinical Quality Safety Governance Group and then (dependant of risk and impact to the organisation) go to Senior Leadership Board for organisational approval.

All reusable loan/trial medical devices must be registered with, and checked by the clinical engineering team before entering service. At the end of the trial the medical devices must be returned to the supplier via the clinical engineering team.

Please be aware that to keep our patients and staff safe, no new medical device should be brought into the Trust without the correct procedures being followed and the correct approvals received.

Published 2nd November 2018

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