Summary
Most surgeons, manufacturers and regulators of implants believe that analysis of explants is an essential requirement in the monitoring of all Total Joint Replacements (TJRs). All the stakeholders in Beyond Compliance (BC) agreed with this initiative but at present we know of only four explants that have been sent to retrieval centres in the UK out of more than 400 BC revisions.
Beyond Compliance (www.beyondcompliance.org.uk) was set up about seven years ago as a voluntary system to oversee the introduction of new implants. We see analysis of explants as an important part of our monitoring service. Obviously we all hope that explants, removed for any reason, fail to show significant evidence of wear or other damage but, if they do, action may be required.
To make it work we all need to help change the mindset of surgeons and theatre staff who are involved in revision surgery.
Background
Between 2012-13 the House of Commons science and technology committee met, following the problems with metal-on-metal THRs, to discuss the regulation of medical implants in the EU and UK. The following is an excerpt from Hansard, written after the committee had deliberated.
“We call for the conservation and analysis of explanted joints to be made mandatory as part of the NJR reporting procedure.”
Clearly this initiative has not born fruit! There are now more than 38,000 implants in the BC process and, of these, just over 300 have been revised. As far as we know, so far, only four have been examined.
Several reasons have been put forward for this poor response and they include having patient consent and lack of co-operation from theatre staff.
Whose joint is it? Who does it actually belong to?
It is generally accepted that the implant belongs to the patient and we need consent to do anything with it. Next in line is the manufacturer. Many patients do not seem to trust the manufacturer to be entirely honest or diligent and neither do some surgeons. Manufacturers are aware of this and, by and large, they all seem to respect and trust the retrieval centres.
Sometimes solicitors will have a say in who owns a client’s implant, where there are ongoing medicolegal issues. It is very important that the implant can always be identified as “the correct one” and never gets lost.
Beyond Compliance Explant Alliance
There are four centres in the alliance. They are Southampton, London Implant Retrieval centre (LIRC) at the Royal National Orthopaedic Hospital (RNOH), www.lirc.co.uk, Leeds and the Northern Retrieval Registry (NRR) in Newcastle, http://www.retrievalregistry.com.
The LIRC and the NRR will stock hospitals with the explant carriers ready for use. NRR have a group of hospitals, which they serve on a comprehensive basis, and this will continue.
LIRC have recently been developing a process with Northgate Public Services (the company who provides the IT platform for Beyond Compliance and the National Joint Registry), to facilitate both the carriage and the initial assessment of an implant for all those other hospitals who would like to be involved and where BC implants are regularly used and, when indicated, revised. It is intended to work as follows:
The surgeon places the implant into the container in the theatre without interfering with it in any way. The container is sealed and sent to LIRC with the clinical data.
On receipt of the implant, the LIRC will document all the components details, note any obvious abnormal finding, photograph it, decontaminate it and securely store it for further onward or local assessment.
The alliance has developed a standardised list of available assessments to be followed as indicated by the circumstances. Histological examination of the local tissues to the joint is also essential.
Funding
It is anticipated that providing an operating theatre with a container will be free of charge, but the manufacturer who agrees to join the scheme will be charged a basic fee for the initial process.
The full forensic assessment will be costed out on the basis of what is going to be required and the retrieval centres each have a list of fees.
Transparency
It is intended that all details of these arrangements will be published on the BC website.
Comments from manufacturers, surgeons and anyone interested in supporting this initiative are more than welcome. It is very much hoped that all manufacturers will help by encouraging the use of this service. A negative report must be good for the portfolio.
Authors
Alister Hart, John Skinner and Harry Hothi, London Implant Retrieval Centre
David Langton, and Tom Joyce, Northern Retrieval Registry
Richard Armstrong, Northgate Public Services
Keith Tucker, FRCS Chairman of the Beyond Compliance Advisory Group, on behalf of the Beyond Compliance Explant Alliance
