The HTM01-01 document is set to replace the CFPP series and has chosen to revert back to the HTM format and will follow the Essential Quality Requirements and Best practice standards which aligns it with the current HTM01-05.
This guidance document will outline how reusable medical devices be decontaminated, used and managed and should support dental practices to form policies and protocols with clear guidance….. Easier said then done you might say…
These changes have come largely due to DOH advice on Protein Detection limits – the magic number is now set to be 5ug per side of instrument after processing but its not all plain sailing!
The advice given in this current version states that while there is no evidence to suggest this new limit removes the risk of prion transmission, that for lower risk tissue contact, the figure of 5ug is achievable by effective cleaning. The focus has changed from removing heavy soiling to reducing the numbers of highly adherent proteins to very low levels.
For this to be possible, the time from procedure to reprocessing must be reduced and when delayed, instruments must remain moist. We discussed this in recent Blogs regarding InstruPak and Instrument Transport protocol. Instrument transport and moisture is also mentioned in the HTM 01-05 and suggests that a foam spray or moisture controlled bag should be employed to ensure proteins are not allowed to dry onto the surface on instruments.This is a practice, it seems, that may become of a higher priority in order to reduce the risk to patients and should be considered by Dental Practices now.
The second sticky issue is that of Protein Detection Methods – the current guidance states-
“SSDs should no longer rely on elution or swabbing to detect residual protein” and that Products are being developed that “can detect the 5ug limit in situ”.
While it would be great if every practice in the UK had the budget to afford the expensive piece of kit the guidance is referring to, that may not be realistic but that is not what they are saying….
The guidance, as it stands, is asking health providers have a plan of continuous improvement in place which should identify the level of risk and detail how that risk is to be managed. At a local level, Dental practices must adopt and develop procedures appropriate to their services – this is not a one size fits all as with all HTM guidance.
The guidance is asking for providers to not “rely” on the RPT but to use it in conjunction with a PCD to validate efficacy and mechanical ability and to record results, analyse trends and create action plans.
In plain english – use your Residual Protein Test, but use it along side a Wash Test (PCD) and use this combination method to control the risks identified in your practice policy documentation. By using a Wash Check to validate the process and the Protein test to validate the result, your not relying on one or the other to give a definitive answer, rather your building up a picture of how effective your overall practice policy is.
At this stage the document is drafted, but gives us an indication of where the guidance may be heading.
I look forward to the publication of the revised document and hope it provides clear advice on the practical application of protein testing as a method of validation
Originally posted 2016-05-18 14:38:35. Republished by Blog Post Promoter