Med Tech-related technology assessments and clinical guidelines from NICE in March 2022

28

Apr 2022

In March 2022, NICE published five new Interventional Procedures Guidance (IPG):

  • Endoscopic balloon dilation for subglottic or tracheal stenosis;
  • Intramedullary distraction for lower limb lengthening;
  • Endoscopic full thickness removal of gastrointestinal stromal tumors of the stomach;
  • Percutaneous insertion of a cystic duct stent after cholecystostomy for acute calculous cholecystitis;
  • Liposuction for chronic lipoedema.

IPG is developed for most of the novel interventional procedures entering the English market. The program focuses solely on clinical evidence. Recommendations may vary from "for research only" to "for use with standard arrangements for clinical governance, consent, and audit." Recommendations are not binding, although they are followed by providers and commissioners.

NICE made the following conclusions in new IPGs:

  • Evidence on the safety of endoscopic balloon dilation for subglottic or tracheal stenosis is adequate. The most serious complication related to the procedure, independent of age, is a tracheal laceration, but this is well recognized. Evidence on the efficacy and recommendations differ for adults and children: for neonates, children, and young people, evidence on the efficacy of the procedure is adequate to support using it with standard arrangements for clinical governance, consent, and audit; for adults, evidence on the efficacy of the procedure is limited, so, it should only be used with special arrangements for clinical governance, consent, and audit or research;
  • Evidence on the safety and efficacy of intramedullary distraction for lower limb lengthening is limited in quantity and quality. Therefore, this procedure should only be used with special arrangements for clinical governance, consent, and audit or research;
  • Evidence on the safety and efficacy of endoscopic full thickness removal of gastrointestinal stromal tumors of the stomach is inadequate in quality and quantity. Therefore, this procedure should only be used in the context of research;
  • Evidence on the safety and efficacy of percutaneous insertion of a cystic duct stent after cholecystostomy for acute calculous cholecystitis is inadequate in quality and quantity. But because patients would otherwise need permanent external drainage, the procedure can be considered for this condition with special arrangements for clinical governance, consent, and audit or research;
  • Evidence on the safety of liposuction for chronic lipoedema is inadequate but raises concerns about major adverse events such as fluid imbalance, fat embolism, deep vein thrombosis, and toxicity from local anesthetic agents. Evidence on the efficacy is also inadequate, based mainly on retrospective studies with methodological limitations. Therefore, this procedure should only be used in the context of research.

Medical Technologies Guidance (MTG) evaluates new, innovative medical devices and diagnostics. It looks at medical technologies that deliver treatment, like those implanted during surgical procedures, give greater independence to patients, or detect or monitor medical conditions.

In March 2022, NICE issued four new MTGs and made the following recommendations:

The Diagnostic Guidance (DG) program focuses on evaluating innovative medical diagnostic technologies to ensure that the NHS can adopt clinically and cost-effective technologies rapidly and consistently. In March 2022, NICE terminated the development of DG on Freelite assays for diagnosing multiple myeloma and related conditions.

The MedTech Innovation Briefings (MIBs) is the advice program of NICE for innovative technologies. It provides an overview of clinical effectiveness, safety, and cost. It does not offer formal guidance, and it, therefore, does not provide any recommendations. Six new MIBs published in March 2022 are:

Three new clinical guidelines were published in March 2022; however, non of them were Medtech-related:

  • Integrated health and social care for people experiencing homelessness;
  • Disabled children and young people up to 25 with severe complex needs integrated service delivery and organization across health, social care, and education;
  • Mental wellbeing at work.

Six clinical guidelines were updated in March 2022:

See the full details for guidance here. and for MIBs here

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