The National Institute for Health and Clinical Excellence (NICE) has issued full guidance to the NHS in England, Wales, Scotland and Northern Ireland on direct skeletal fixation of limb or digit prostheses using intraosseous transcutaneous implants.
If a leg, arm, finger or thumb has had to be amputated, or is missing at birth, an artificial substitute (known as a prosthetic limb or prosthesis) may be fitted. Prosthetic limbs usually have a socket and are held in place either by suction or by being strapped to the stump of the missing limb. In this procedure, a metal implant is inserted through the skin and into the centre of the bone of the stump. A prosthetic limb is then attached to the metal implant. The aim is to produce a more comfortable and securely attached prosthetic limb.
This guidance represents the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, healthcare professionals are expected to take this guidance fully into account, and specifically any special arrangements relating to the introduction of new interventional procedures. The guidance does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
All problems (adverse events) related to a medicine or medical device used for treatment or in a procedure should be reported to the Medicines and Healthcare products Regulatory Agency using the Yellow Card Scheme.
Commissioners and/or providers have a responsibility to implement the guidance, in their local context, in light of their duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity, and foster good relations. Nothing in this guidance should be interpreted in a way that would be inconsistent with compliance with those duties. Providers should ensure that governance structures are in place to review, authorise and monitor the introduction of new devices and procedures.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.