The National Institute for Health and Clinical Excellence (NICE) has issued full guidance to the NHS in England, Wales, Scotland and Northern Ireland on soft-palate implants for obstructive sleep apnoea.
Obstructive sleep apnoea (OSA), or obstructive sleep apnoea/hypopnoea syndrome, is characterised by repeated, reversible episodes of apnoea and hypopnoea during sleep, loud snoring and excessive daytime sleepiness.
The procedure is usually performed under local anaesthesia. A hollow introducer needle containing the implant is used to pierce the soft palate, close to the junction with the hard palate, reaching into the muscle layer. The needle is then withdrawn, leaving the implant in position. Typically two or three implants are inserted in a single procedure, at the midline of the soft palate or parallel to it. The aim of the procedure is to stiffen the soft palate over subsequent weeks as a result of fibrosis.
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.