In January 2020, the National Institute for Health and Care Excellence (NICE) published only three new interventional procedure guidance (for reducing the risk of transmission of Creutzfeldt–Jakob disease (CJD) from surgical instruments used for interventional procedures on high-risk tissues, fetoscopic and open prenatal repair for open neural tube defects in the fetus).
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 January 2020, NICE published three new Interventional Procedure Guidance:
- Interventional Procedure Guidance Reducing the risk of transmission of Creutzfeldt–Jakob disease (CJD) from surgical instruments used for interventional procedures on high-risk tissues, which covers evidence-based recommendations on reducing the risk of transmission of Creutzfeldt–Jakob disease (CJD) from surgical instruments used for interventional procedures on high-risk tissues. All surgical instruments that come into contact with high-risk tissues during an interventional procedure must be kept moist and separated from other instruments until they are cleaned and then disinfected and sterilized (decontaminated). This improves the efficacy of the decontamination process and is highly cost-effective. Rigid neuroendoscopes (rather than flexible neuroendoscopes) should be used if possible. The evidence on cost-effectiveness does not support using sets of single-use instruments to reduce the risk of Creutzfeldt–Jakob disease (CJD) transmission and other recommendations were provided.
- Interventional Procedure Guidance Fetoscopic prenatal repair for open neural tube defects in the fetus, which covers evidence-based recommendations on the fetoscopic prenatal repair of open neural tube defects in the fetus. Evidence on the safety and efficacy of fetoscopic prenatal repair of open neural tube defects in the fetus is inadequate in quantity and quality. Therefore, this procedure should only be used in the context of research.
- Interventional Procedure Guidance Open prenatal repair for open neural tube defects in the fetus, which covers evidence-based recommendations on the open prenatal repair of open neural tube defects in the fetus. Evidence on the efficacy of open prenatal repair of open neural tube defects in the fetus is adequate in quantity and quality. However, evidence on its safety shows serious but well-recognized safety concerns for the mother and fetus. Therefore, this procedure should only be used with special arrangements for clinical governance, consent, and audit or research.
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This is a syndicated report on HTA landscape and all published non-drug HTAs in Europe in 2018, including medical devices and procedures, in-vitro diagnostic tests and e-health solutions. The HTA report covers 12 EU countries (Austria, Belgium, Denmark, England, France, Germany, Italy, Netherlands, Norway, Spain, Sweden, Switzerland) and EUnetHTA.
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