By Keith Tucker1 and Peter Kay2
1Chair of ODEP and Beyond Compliance Advisory Group
2Chair of the Beyond Compliance Steering Committee
Published 11 September 2020
Let’s start by quoting to you a passage from the report 'First do no harm' (July 2020).
"Innovation in medical care has done wonderful things and saved many lives. But innovation without comprehensive pre-market testing and post-marketing surveillance and long-term monitoring of outcomes is, quite simply, dangerous. Crucial opportunities are lost to learn about what works well, what does not, what needs special measures put around its use, and what should be withdrawn because the risks over time outweigh the benefits. Without such information it is not possible for doctors and patients to understand the risks, and patients cannot make informed choices. This applies both to medications and to medical devices…"
What the report also makes clear is that we, as users of medical implants /devices, are responsible for reporting problems (whilst also supporting the good).
Reading on, the report points out how difficult it was for them to assess the data on vaginal mesh issue because there was little data to be found. Nowadays, we have all the tools we need to monitor implants, together with the technology to analyse the data, provided we have the will to do so.
So, where do we, as surgeons fit in? The strap line for our association, the BOA, is 'Caring for Patients, supporting Surgeons' and this must include doing our best to provide our patients with the safest implants. Thus, all together, we have a duty to facilitate the workings of all the agencies that monitor implants ranging from: making sure consent forms are signed, completing adverse incident reports, encouraging patients to complete PROMS studies, sending implants (whether they looked damaged or not) to recognised retrieval centres and generally sharing our experiences with others.
Following the lead of Baroness Cumberlege the Royal College of Surgeons CPD group recognises the importance of our responsibility to contribute to the safety of patients. Her report is important reading as it will be undoubtedly form the basis for the monitoring of new and legacy implants for many years to come.
*A fuller reaction to the Cumberlege Report from ODEP and Beyond Compliance will be published in the December edition of JTO.