By in General, Surgical Instruments

Htm 01-01 & Impact on Reusable Surgical Instruments

July saw the release of the much anticipated HTM 01-01 for the reprocessing of reusable surgical instruments. This has been released to replace the outgoing CFPP’s. The CFPP’s didn’t seem to be particularly popular, so this may be a welcome return for many in the industry.

Reusable Mayo Scissor

The main amendments in the new document are the introduction of protein testing. The new surgical instrument life cycle introduces protein testing during the inspection stage (Source: There are different ways of testing protein, however, after attending a recent CSC (Central sterilising club) seminar day, in Birmingham, there is a general mix in opinion in the best way to apply the testing.

With the introduction of new guidance like this, there is always going to be a period of trying to interpret what the guidance requires you to do. This is very important as ultimately sterile service departments require this information to ensure they meet the guidance for audits. The CSC showed that we are definitely at this stage with the new guidance!

The morning of the CSC saw Anita Jones from Edinburgh University introduce the differing ways that protein could be measured or detected. This led onto a discussion of the differing approaches each country are taking, with presentations from each country. Scotland have commissioned their own study, which they feel will give NHS Scotland the best outcome. Northern Ireland it seems are ready to go, once they decide the way they are going with the testing, they will roll it out. Wales it seems are still researching and testing and deciding on the best course of action to implement country wide.

The afternoon session was from the ‘users’ perspective; the stakeholders that are waiting for the overall direction from possibly their centralised approach. Paul Jenkins from North Bristol NHS Trust highlighted how far they have come and the progress they have made in decontamination. One of the main concerns seem to be the uncertainty of ‘what if my instruments fail’, once they’re using the tests? The reusable instrument cycle highlighted testing during inspection, but if there is a failure, do the instruments just get reprocessed, washed again and retested and what if this doesn’t work?

Of course, there are options; instruments could be refurbished to manually remove any protein. there would be no proven need to dispose of the instruments just because they have protein on them, as we can’t distinguish between harmful protein on the instruments through current test methods, so maintenance of the instruments will ensure the trays are kept in use and a failure of a protein test doesn’t grind hospitals to a halt.

The subject of keeping instruments moist after use, is also again recommended in the new htm. It is fairly obvious that if the instruments can be sprayed with ‘something’, after use to prevent dried on debris, it has to be better than letting debris dry on potentially causing corrosion and making the blood very hard to remove through washing, so any products that help safely achieve this have to be a positive step. The HTM proposes using appropriate methods approved and verified by the SSD, it is difficult to understand what this means.

After researching into the products available on the market that are sold for application after surgical use (to keep the instruments moist), there isn’t much detail on recommended timings for leaving the moisture products on the instruments. This raises some concerns, as surgical instruments are mostly manufactured using a carbon stainless steel alloy which when left wet, can potentially corrode. So, there needs to be some guidance from manufacturers selling the products as to how long the instruments should be left on the instrument, once the treatments are applied, before they need to be washed off. This will help Sterile Services staff to make the right decisions and ensure the life of their instrument stock is not detrimentally affected.

For patient safety, the new guidance has to be a step forward, but ensuring the guidance is rolled out and interpreted correctly is always tricky.

The new HTM 01-01 will come into force next year.



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Daniel Coole has been involved in the surgical instruments and the medical device industry for the past 17 years and is the Managing Director of innovative surgical instrument manufacturer, Surgical Holdings. Daniel is also the Vice Chairman of the Association for British Healthcare Industries Surgical Instrument Group.

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