The British Society for Surgery of the Hand (BSSH) is a charity representing patients with hand disease, pathology or injury and the surgical teams that treat them.
In July 2020, Baroness Cumberlege published the findings of an Independent Medicines and Medical Devices Safety Review, commissioned by the UK Government. The review investigated patient harm from medicines and medical devices, and cited three specific areas of identifiable harm: historic use of a teratogenic pregnancy test, harmful effects of sodium valproate use during pregnancy, and surgically implantable pelvic mesh and its subsequent failure and resultant patient harm.
To better regulate surgical implant use and mitigate unrecognised harm, the Cumberlege Report recommended that all implants should be traceable from point of manufacture to implantation and beyond. This robust monitoring could facilitate early identification of poorly performing or dangerous implants.
Historically, plates and screws used in orthopaedic trauma surgery have been sterilised on an implant and instrument tray and replenished with new implants on this tray as required. Whilst this had numerous surgical benefits – immediate availability of screws, ability to template precisely, technical ease for scrub teams and surgeons alike – these implants are not traceable and thus not supported by the recommendations made by Baroness Cumberlege.
Hand and finger injuries are the most common cause for presentation to the Emergency Department (ED) and fractures to the hand and wrist comprise 30% of all bony trauma. There is substantial morbidity associated with hand trauma.
Fixation of hand fractures involves use of micro-screws and plates. These are more difficult to handle when packed to allow full traceability, impairing the surgeon’s ability to safely treat injuries. Many similar implants have been excluded from the traceability legislation on the basis of their small size.
However, there is increasing pressure from regulatory bodies for hand surgeons to adopt the use of single item sterile trauma implants, termed pre-packed implants (PPIs). Hand surgeons throughout the UK are of the opinion that this would compromise care of hand surgery patients and would contradict the principles of Values Based Healthcare. This has been echoed by hand surgeons in Scotland, where PPIs have been enforced for the past few years.
Hand surgeons throughout the UK are of the opinion that a move to using sterile packed implants is neither indicated nor clinically practical. It would be to the detriment of the environment, add significant financial burden to the NHS, and most importantly would result in worse outcomes for patients.
Read the complete report here, or find the 1-page summary here.
This report discusses the implications for patients and the concerns shared by the hand surgery community.
Source: British Society for Surgery of the Hand
Image: Canva
