1. What are Medtech Innovation Briefings (MIBs)?
NICE (National Institute for Health and Care Excellence) Medtech Innovation Briefings (MIBs) are designed to support NHS and social care commissioners and staff who are considering using new medical devices and other medical or diagnostic technologies. The information provided includes a description of the technology, how it’s used and its potential role in the treatment pathway. A MIB also includes a review of relevant published evidence and the likely costs of using the technologies, but they are not NICE guidance and do not make any recommendations on the value of using the technologies. The briefings will help avoid the need for organisations to produce similar information locally, so saving staff time, effort and resources. MIBs are designed to be fast, flexible and responsive to the need for information on innovative technologies.
NICE MIB: Summary
The technology described in this briefing is HemaClear. It is used for limb exsanguination during limb surgery to provide a bloodless surgical field.
The innovative aspects are that it is a single-use sterile device, which the company claims is quicker and simpler to use and reduces the number of adverse events compared with existing devices. It may also be used outside of the operating theatre (for example, in a procedure room for minor cases).
The intended place in therapy would be as an alternative to the pneumatic tourniquet system in people needing limb surgery where a bloodless field is needed.
The main points from the evidence summarised in this briefing are from 6 studies: 3 prospective randomised comparative studies, 2 retrospective comparative studies and 1 mixed retrospective/prospective comparative study. Out of a total of 539 patients, 328 patients used the device (named as S‑MART or HemaClear depending on the date of the study) in the operating theatre. They show that the device may be as effective as pneumatic tourniquets in providing a bloodless field in the adult population.
Key uncertainties around the evidence or technology are that there is uncertainty surrounding some outcomes such as pain and complications and a lack of medium- to long-term follow up.
The cost of HemaClear is between £15.95 and £41.80 (excluding VAT) per unit. The resource impact could be lower if its use shortened surgery time or reduced the number of adverse events.