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ODEP and Beyond Compliance: Our response to Cumberlege, the MDR and the UKCA... making UK plc a good place for safe innovation of implants Keith Tucker and Peter Kay
After about nine month’s delay, Baroness Julia Cumberlege’s long awaited ‘Independent Medicines and Medical Devices Safety Review’, “First Do No Harm” was published on 4th July 2020.
Keith Tucker is the Chair of ODEP and the Beyond Compliance Advisory Group. He has also served on the NJR Steering committee, the MHRA metal on metal advisory group and the ISAR board. He continues to serve on the NJR Implant scrutiny committee, NORE and as a trustee for ORUK.
Peter Kay is a Consultant Orthopaedic Surgeon at Wrightington, Wigan and Leigh NHS Foundation Trust, honorary Clinical Professor of Orthopaedic Surgery at Manchester University and honorary Professor in Orthopaedics at University of Central Lancashire. Peter has been President of the British Orthopaedic Association (2011), British Hip Society (2008) and British Orthopaedics Trainees Association (1992). He is Chair of the Beyond Compliance Steering Committee.
It must be the view of the great majority of us that what she recommends makes perfect sense. As far as orthopaedics is concerned, it will impact on us (provided parliament adopt her recommendations) in several ways:
So where is ODEP and Beyond Compliance in this? Well, she mentioned the NJR as a beacon organisation that others should follow and I am sure we all agree it certainly is! We think it was unfortunate that ODEP and BC were not introduced to her but what we have been doing since 2002 for ODEP and 2012 for Beyond Compliance fits very closely with her recommendations.
• All implants used on patients will have to Where are we all with the new MDR? go into a registry and ‘Scan for Safety’ is highlighted and plans are already afoot for its Oliver Bisazza from MedTech Europe has development. summarised the introduction of the new MDR • The monitoring of new devices should not be very well in Figure 1. left to the PI (Principal Investigator), their team and the manufacturer. An independent However, earlier this year, because of COVID-19, body should be involved which is, of course, the next time point in the implementation stage what the Beyond Compliance advisory group was put back until May 2021. The important have been doing for some years now. points to realise are: • Anyone involved in the introduction of new devices should increase their emphasis on PROMS and PREMS. • We all need to increase our engagement with patients and the lay public when dealing with implants. • She emphasised the importance of anyone externally monitoring implants should be completely independent and without a conflict of interest (COI). That’s pretty easy for ODEP and Beyond Compliance as none Figure 1: Introduction to MDR – Courtesy of Oliver Bisazza (MedTech Europe). of us are paid!
28 | JTO | Volume 08 | Issue 04 | December 2020 | boa.ac.uk
