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Med Tech-related technology assessments and clinical guidelines from NICE in March 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:
- More research is recommended on myCOPD for managing chronic obstructive pulmonary disease in adults. Using it for self-managing COPD and remote pulmonary rehabilitation could provide significant patient and healthcare system benefits if uncertainties in the evidence are addressed;
- UroShield for preventing catheter-associated urinary tract infections has the potential to provide significant patient and healthcare system benefits, but uncertainties in the evidence need to be addressed. More research is recommended;
- Prontosan for treating acute and chronic wounds is not recommended for treating acute wounds because the evidence is very limited. More research is recommended on the effectiveness of Prontosan compared with saline or water in chronic wounds of different types;
- 3C Patch for treating diabetic foot ulcers is not recommended as a cost-saving option for diabetic foot ulcers.
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:
- Genedrive MT-RNR1 ID System for detecting single nucleotide polymorphism m.1555A>G in newborn babies, a point of care test to identify the risk of (and avoid) antibiotic-related hearing loss in newborn babies;
- icobrain ms for active relapsing-remitting multiple sclerosis, a software that quantifies the brain MRI scans and summarises clinically relevant findings in concise, structured electronic radiological reports with annotated images. It helps assess disease activity or early signs of disease progression;
- Artificial intelligence for analysing chest X-ray images. The briefing included three software technology (qXR, red dot, Lunit INSIGHT CXR). The unit costs of the technologies range between £0.90 and £1.66 per image processed, which would be in addition to standard care;
- SecurePort IV tissue adhesive for use with percutaneous catheters, a 2-octyl-cyanoacrylate tissue adhesive that seals and secures the insertion site and uses a formulation with antimicrobial properties to reduce catheter-related infections;
- YOURmeds for medication support in long-term conditions, the first digital medication dosage system that allows real-time monitoring of medication adherence;
- Lumella point-of-care test for assessing pre-eclampsia risk is based on a novel biomarker (glycosylated fibronectin) that may have improved sensitivity and specificity compared with standard care.
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:
- Type 1 diabetes in adults: diagnosis and management: NICE reviewed the evidence and updated the recommendations on diagnosis and continuous glucose monitoring (CGM);
- Diabetes (type 1 and type 2) in children and young people: diagnosis and management: NICE reviewed the evidence and updated the recommendations on CGM;
- Type 2 diabetes in adults: management: NICE made new recommendations on CGM;
- Hypertension in adults: diagnosis and management: NICE reviewed the evidence and made a new recommendation on blood pressure targets for people who have both hypertension and cardiovascular disease;
- COVID-19 rapid guideline: managing COVID-19;
- Otitis media (acute): antimicrobial prescribing.
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