BSSH Statement: Sterile Implants in Hand and Wrist Surgery
28 November 2023
Statement concerning Sterile Implants in Hand & Wrist Surgery
The British Society for Surgery of the Hand
November 2023
This statement is the current expert opinion of the British Society for Surgery of the Hand (BSSH).
In producing this statement, the BSSH have considered the literature around implant sterility and the input of hand surgery colleagues regarding their day-to-day hand and wrist trauma surgery practice.
We recognise concerns exist around the re-processing of so-called single-use items and the difficulties in implant traceability that non-sterile implants on an implant tray may cause. However, it is the clinical opinion of the BSSH that a move to sterile packed implants in Hand and Wrist trauma surgery will unavoidably compromise surgery and the clinical outcome.
There has been a recent push towards sterile packed implants on orthopaedic implant trays. The driver for this is recent legislative changes around Medical Device Regulation (MDR) and concerns regarding infection as well as theoretical risks of corrosion and the secondary concerns around increased infection risk. These have not been proven clinically.
The BSSH has identified significant and unacceptable clinical risks surrounding the use of pre-packed sterile implants in hand and wrist surgery, all leading to an increased risk of patient harm. These include:
- Increased operative time with the associated added risks of infection and ischaemic tourniquet damage
- Increased difficulty in operative fracture reduction
- Increased difficulty for scrub staff
- Impossibility of optimal implant selection
- Increased risk of appropriate implant unavailability
- Requirement for additional stock management and supply
- Massive increase in plastic waste and reduced sustainability
- No demonstrable or proven benefit for hand surgery patients
As a specialist society representing the views of hand and wrist surgery experts across the UK, we have made huge improvements along the principles of Getting It Right First Time (GIRFT). The move to sterile packed screws goes against these principles, making hand surgery considerably more difficult to get it right first time. Furthermore, we do not acknowledge the theoretical risks of infection secondary to resterilised implants – this has not been a recognised clinical problem in the history of fracture surgery. However, we have vast experience of the difficulties this directive will cause for the safe and effective treatment of hand and wrist trauma patients.
The BSSH recommends that any plans to move to sterile packed implants are only made with the full agreement of the relevant stakeholders after an appropriate consultation process. It is imperative that theoretical risks of harm are not attributed a greater importance than the demonstrable risks described above.
The BSSH is commissioning a full review of the issues surrounding sterile packed implants, with particular reference to hand and wrist trauma surgery. The full report of this working group will be available in 2024.
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