Med Tech-related technology assessments and clinical guidelines from NICE in May 2019

In May 2019, the National Institute for Health and Care Excellence (NICE) published one new diagnostics guidance for Lead-I ECG devices for detecting symptomatic atrial fibrillation using single time point testing in primary care, three new interventional procedure guidance (for therapeutic hypothermia for acute ischaemic stroke, collagen paste for closing an anal fistula, and percutaneous mitral valve leaflet repair for mitral regurgitation), two new Medical technologies guidance, and three new MedTech innovation briefings (for SEM Scanner for pressure ulcer prevention, Peezy Midstream for urine collection,and DuraGraft for preserving vascular grafts).

Diagnostics guidance evaluates new, innovative diagnostic technologies. It includes all types of measurements and tests that are used to assess a patient's condition. The guidance helps people in the NHS make efficient, cost-effective, and consistent decisions about adopting new products. It supports innovation, transformation, and improves healthcare delivery.

In May 2019, NICE published one new Diagnostics Guidance for Lead-I ECG devices for detecting symptomatic atrial fibrillation using single time point testing in primary care. There is not enough evidence to recommend the routine adoption of lead-I electrocardiogram (ECG) devices (imPulse, Kardia Mobile, MyDiagnostick and Zenicor-ECG) to detect atrial fibrillation when used for single time point testing in primary care for people with signs or symptoms of the condition and an irregular pulse. Further research is recommended.

Interventional Procedure Guidance 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.

In May 2019, NICE published three new Interventional Procedure Guidance:

• Interventional Procedure Guidance Therapeutic hypothermia for acute ischaemic stroke, which covers evidence-based recommendations on n therapeutic hypothermia for acute ischaemic stroke in adults. Current evidence on the safety of therapeutic hypothermia for acute ischaemic stroke shows that there are serious complications. Evidence on efficacy does not show any meaningful improvement in outcomes. Therefore, this procedure should not be used
• Interventional Procedure Guidance Collagen paste for closing an anal fistula, which covers evidence-based recommendations on collagen paste for closing an anal fistula in adults. Current evidence on the safety and efficacy of collagen paste for closing an anal fistula is inadequate in quantity and quality. Therefore, this procedure should only be used in the context of research
• Interventional Procedure Guidance Percutaneous mitral valve leaflet repair for mitral regurgitation, which covers evidence-based recommendations on percutaneous mitral valve leaflet repair for mitral regurgitation in adults. Current evidence on the safety and efficacy of percutaneous mitral valve leaflet repair for mitral regurgitation is adequate to support the use of this procedure, in patients for whom open surgery is contraindicated following a risk assessment, provided that standard arrangements are in place for clinical governance, consent and audit

Medical technologies guidance 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 May 2019, NICE published two new Medical Technologies Guidance:

• Medical Technologies Guidance PICO negative pressure wound dressings for closed surgical incisions covers evidence-based recommendations on PICO negative pressure wound dressings – a canister-free, single-use, negative pressure wound therapy system consisting of a sterile pump and multi-layered adhesive dressings. Evidence supports the case for adopting PICO negative pressure wound dressings for closed surgical incisions in the NHS. They are associated with fewer surgical site infections and seromas compared with standard wound dressings. PICO negative pressure wound dressings should be considered as an option for closed surgical incisions in people who are at high risk of developing surgical site infections
• Medical Technologies Guidance Curos for preventing infections when using needleless connectors covers evidence-based recommendations on Curos disinfecting cap (3M) – a single-use device which is placed over the needleless connector of vascular access lines. It contains a foam that is impregnated with 70% isopropyl alcohol, which acts as an antiseptic. Curos disinfecting cap shows promise for preventing infections when using needleless connectors, but there is currently insufficient evidence to support the case for routine adoption in the NHS. Research is therefore recommended to address uncertainties about the clinical benefits of using Curos

MedTech Innovation Briefing is the NICE's advice program 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.

Three new Medtech Innovation Briefings for SEM Scanner for pressure ulcer prevention (used for detecting changes in sub-epidermal moisture (SEM) to show pressure-induced tissue damage which can become a pressure ulcer), Peezy Midstream for urine collection (used only for collecting a midstream urine, without needing the patient to interrupt the flow of urine. ), and DuraGraft for preserving vascular grafts (a preservation solution used during operations for storing harvested blood vessels that will be used in coronary artery bypass graft (CABG) surgery) have been published in May.

See full details in English here.

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