The National Institute for Health and Care Excellence (NICE) has issued full guidance to the NHS in England, Wales, Scotland and Northern Ireland on Insertion of customised exposed titanium implants, without soft tissue cover, for complex orofacial reconstruction.
This guidance and NICE interventional procedure guidance 449 together replace interventional procedure guidance 28 – Customised titanium implants for orofacial reconstruction (December 2003)
Titanium implants can be inserted to replace bones in the face as part of orofacial reconstruction, that is, rebuilding the face when there is severe damage to the bones or deformity. This is most commonly needed after injury or surgery to remove tumours, or to treat deformities of the face that have been present from birth.
In this procedure, the implants are customised (made specially to fit the person). An accurate model is made of the bones of the person’s face. The model is used as a template to make the implant, which is then fixed in position using titanium screws during an operation. The implant is not covered by soft tissue.
This procedure cannot be expressed in the OPCS-4 classification by a single code. Code assignment would depend on where the implant was placed and if any other procedures involving the adjacent structures were also performed. The procedure must therefore be coded on a case by case basis, subject to the other actions carried out as documented in the patient’s medical record.
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.