In England, the National Institute for Health and Care Excellence (NICE) provides national guidance and advice to improve health and social care. It develops med-tech innovation briefings, clinical guidelines, quality standards, etc.
The interventional procedure guidance (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. Two new IPGs were released in April of 2019 by NICE:
- IPG for endoscopic ablation for an anal fistula. The procedure aims to preserve sphincter-muscle function and fecal continence and may be done in combination with surgical techniques such as creating a mucosal advancement flap. The evidence on assessed intervention raises no major safety concerns and the evidence on efficacy is adequate in quality and quantity. Therefore, this procedure can be used provided that standard arrangements are in place for clinical governance, consent, and audit
- IPG for endoscopic ablation for a pilonidal sinus, which is less invasive procedure than surgery and is usually done as a day case, using spinal or local anesthesia. The assessment covers evidence-based recommendation for the treatment. The evidence on the evaluated intervention raises no major safety concerns and the evidence on efficacy is adequate in quality and quantity. Therefore, this procedure can be used provided that standard arrangements are in place for clinical governance, consent, and audit.
MedTech Innovation Briefing (MIB) 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 offer any recommendations.
Two new MIBs were released by NICE in April of 2019:
- ADXBLADDER for detecting bladder cancer for a urine test for detecting bladder cancer in people with symptoms associated with malignancy, including blood in the urine or lower urinary tract symptoms
- LiverMultiScan for liver disease for imaging software designed to be used with MRI to help clinicians to diagnose and stage liver disease
See the full information in English here.
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