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

In November 2019, the National Institute for Health and Care Excellence (NICE) published two new diagnostics guidance (for point-of-care creatinine devices and rapid tests for group A streptococcal infections), one new interventional procedure guidance (for irreversible electroporation for primary liver cancer) and two new MedTech innovation briefings (for Leukomed Sorbact for preventing surgical site infection and AmnioSense for unexplained vaginal wetness in pregnancy).

In November 2019, NICE published two new Diagnostics Guidance:

• Point-of-care creatinine devices to assess kidney function before CT imaging with intravenous contrast, which covers evidence-based recommendations on point-of-care creatinine devices to assess kidney function before CT imaging with intravenous contrast. The tests are ABL800 FLEX, i-STAT Alinity and StatSensor, ABL90 FLEX PLUS, Dri chem NX500, epoc Blood Analysis System, and Piccolo Xpress. Point-of-care creatinine devices ABL800 FLEX, i‑STAT Alinity, and StatSensor, which calculate estimated glomerular filtration rate (eGFR), are recommended to assess kidney function to guide decisions on whether to use intravenous contrast during an outpatient CT scan in adults under certain conditions. Point-of-care creatinine devices ABL90 FLEX PLUS, Dri‑chem NX500, epoc Blood Analysis System, and Piccolo Xpress are not recommended to assess kidney function to guide decisions on whether to use intravenous contrast during an outpatient CT scan. This is because there are insufficient data to assess their diagnostic accuracy.
• Rapid tests for group A streptococcal infections in people with a sore throat, which covers evidence-based recommendations on rapid tests for group A streptococcal infections in people aged 5 and over with a sore throat. For children under 5, assessment is described in NICE's guideline on fever in under 5s: assessment and initial management. People who are at higher risk of complications should be offered antibiotics in line with NICE's guideline on antimicrobial prescribing for acute sore throat. Rapid tests for streptococcal A infections are not recommended for routine adoption for people with a sore throat. This is because their effect on improving antimicrobial prescribing and stewardship, and on patient outcomes, as compared with clinical scoring tools alone, is likely to be limited. Therefore, they are unlikely to be a cost-effective use of NHS resources.

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 November 2019, NICE published one new Interventional Procedure Guidance for Irreversible electroporation for primary liver cancer, which covers evidence-based recommendations on irreversible electroporation for primary liver cancer in adults. Evidence on the safety of irreversible electroporation for primary liver cancer shows serious but infrequent and well-recognized complications. Evidence on its efficacy is inadequate in quantity and quality. Therefore, this procedure should only be used in the context of research.

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.

Two new Medtech Innovation Briefings for Leukomed Sorbact for preventing surgical site infection (used for preventing surgical site infection in closed surgical incisions with up to moderate exudate levels) and AmnioSense for unexplained vaginal wetness in pregnancy (a non-invasive test that uses a pH‑dependent color-changing strip to identify amniotic fluid) have been published in November.

See the full details here.

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