Beyond Compliance

The BOA has been working closely with the Medicines and Healthcare products Regulatory Agency (MHRA) over many years to help make decisions when a higher than the expected rate of failing replacement joints are identified. Internationally, the UK was the first to take action in 2010 and again in 2012 as information gathered suggesting concerns about some metal-on-metal hip replacements. Many orthopaedic surgeons, who are members of the BOA, have worked tirelessly to make sure that we were taking the best possible and most responsible decisions which did not unduly raise patients concern and anxiety.

This experience has allowed us to reflect on the current system of introduction of implants and their monitoring. Peter Kay, BOA Past President, and Dr Susanne Ludgate from the MHRA have spearheaded the development of the project called ‘Beyond Compliance’ which promotes the concept that the safest, best and most successful systems are those that always go beyond merely complying to the bare minimum that regulations require.

We need to innovate to improve patient care, we believe that our approach will not only provide the maximum possible protection for patients but also allow the early identification of successful innovation and help promote its adoption.

There are three main processes that ‘Beyond Compliance’ has sought to address all of which improve the quality and safety of care we give our patients:

  1. Improve the rigour of processes around CE marking before an implant is sold by offering good quality advice.
  2. Provide guidance and support for the safe and agreed introduction of innovations.
  3. Provide high quality surveillance and a decision making process to identify failures at the earliest point and suggest appropriate actions.

We believe that surgeons need to know what failed, for what reasons, how failure was identified and whether failure could have been identified even earlier. The Beyond Compliance project therefore has great potential to help us practice safer surgery.

More information about the initiative can be found on the Beyond Compliance website.