GDPUK.com Opinions:: Tony Kilcoyne: a critique of HTM 01-05
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Tony Kilcoyne is a prosthodontic specialist, a dental educator, and an elected member of the GDC. He runs a practice in Haworth in Bronte country, West Yorkshire. He is very well known to GDPUK readers. Dr. Kilcoyne has been a long term, highly vocal critic of the Health Technical Memorandum that has so raised the ire of the English dental profession. In this article, he carefully unpicks the unscientific nature of this document. |
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Cross-infection control is important in everything we do when treating and caring for patients in our Practices or Clinics. Furthermore, we constantly strive for improvements and changes in the way we work and enthusiastically adopt such changes when they have been shown to be both better and more effective than what we do now.
So why all the fuss about HTM 01-05 changes being imposed now?
Well Dentistry is also littered with many failed and experimental changes which arrived on the scene with much hype and promise, but when actually put to the test of real-life Practice were found to disadvantage patients rather than advantage them, were found to have little or no Evidence-Base that supported them more than some existing alternative methods, no proper Impact-Assessments had been done or followed through and in some cases, an embarrassing reversal to more proven/established methods occurred in our patients’ interest. But what happens when the changes proposed are SO far-reaching, that they involve vast sums of money, time, reorganization etc, that they become irreversible by virtue of changing how you do everything?
A recent warning of how such drastic changes can backfire was forcing Surgeons to use disposable surgical equipment to reduce possible prion transmission risks between patients. This Sponsored idea from the DH didn’t go through proper development, testing and impact analysis protocols, but was unilaterally imposed, sadly then found to cause an unacceptable level of additional complications and patient deaths that could have been avoided, so this system had to be abandoned and a return to reusable Surgical instruments occurred.
Do we want to see the same happen to Dentistry via HTM 01-05, which will be potentially causing Practices, PCTs and the DH to divert many £millions away from frontline patient care, just as we are entering a national recession and facing public-sector cuts too. When HTM 01-05 doesn’t have the clear support of the published scientific evidence base, no Impact assessment has been done/published, no third-party independent validation and when even those who were consulted during the writing of HTM01-05, have since publically asked for referral of HTM 01-05 guidelines to NICE, then one REALLY has to have concerns about how HTM 01-05 is being forced upon us all.
Many of you will be aware of how I have raised concerns in the BDJ (http://tiny.cc/WDconcerns ), how the BDA has asked for referral of HTM01-05 to NICE, but this is constantly blocked by the DH ( http://tiny.cc/DHblocksNICE ) and how even Microbiologist patients have raised concerns publically too (http://tiny.cc/CrassAdvice )
So some 3 months after the BDA asked to see the evidence HTM 01-05 was based upon, in December 2009 the DH produced some 90+ references to justify imposing the HTM 01-05 full document upon the Dental Profession.
The first thing that struck me about this list of “references”, was that the minority of these were actual published peer-reviewed scientific articles, with the majority being Man-made rules and regulations. Indeed it seemed to be mainly past British Standards (BS) rules, where future BS standards or even EU rules over-ride these in practice , or even more HTM directives were quoted which all referenced each other with other man-made rules and directives and DH policy papers etc, with VERY LITTLE robust scientific evidence underpinning any of it frankly.
So in a nutshell, some two thirds of what provided as “evidence” for change were mainly committee-created rules-based documents which could easily be superceded by further man-made rules at any time, without impacting on any scientific evidence already out there, because they were not dependent on the science.
So what of the actual published scientific references provided, did they provide compelling evidence of prion risks in Dentistry, were 1000’s of nvCJD cases springing up over the last 20 years of monitoring by the CJD surveillance unit in clusters associated with Dental treatments, did these references confirm the imposed changes prevented prion transmission in any measurable way?
Well the short answer is NO, NO and NO !!!
The longer answer needs a thorough dissection of the provided references, but more significantly looking at the many references that weren’t included, which is beyond the scope of this GDPUK article today, but frankly any small group of objective scientists could tear it apart very easily. Indeed it’s major failing, as any researcher will tell you, is that it has now become clear that HTM 01-05 was NOT based upon a comprehensive review of the scientific literature on cross-infection studies, protocols and evaluations of methods, but a partial and therefore biased and misleading reference list. Any reputable scientific publisher simply would reject it as a paper.
So in reverse order, the Ugly part of HTM 01-05 is it’s poor evidence-based approach and where it does quote some selective references, it still ignores negative findings within it’s own documents, which I exampled in my BDJ letter (http://tiny.cc/WDconcerns ) , see the last reference of a DH document raising a concern about proteins being baked onto instruments by the hot WD cycle.
The Bad part of HTM 01-05 is the process as a whole lacking probity and not even following wider DH “best practice” protocols, that encourage implementing Impact Assessments, Pilots and independent Third-Party scrutiny – this has been a DH sponsored Policy-Based imposition upon the Dental Profession and if nothing else, it should learn that such experimentation should be done before National imposition, so the flawed process has led to a flawed outcome.
The Good part of HTM01-05 is that it has significantly raised awareness of Cross-Infection Control issues and made dental teams look ever-closer at what they do, why they do it and is it really effective in protecting patients and staff.
Another good aspect is the DH has made some minor changes to HTM01-05 already, stating originally that it was a live document and would be reviewed in 2 years time, to now showing at least some willing to consider some changes before then, as evidenced by a CDO newsletter ( http://tiny.cc/CDOmarch2010 )
So what next ?
As a Profession, we all want what is best for our patients, always have done and always will do. Any rules or regulations should, IMHO, have that as their No.1 priority – they should enable us, not disable us to provide best practice.
There is still much that needs fixing in HTM01-05 and I have to say, the vast majority of it is fixable, from removing the requirement of the final super-hot cycle on a WD to prevent baking-on proteins/reduce environmental impact and breakdowns, to storage time in bags being evidence-based to looking again at LDU layouts etc, etc.
It would be a sign of strength by the DH to say OK, we will refer to NICE, we also have some ongoing Impact Analysis and Pilots to trial several methods on a time/motion/cost/patient-access effects in real settings to help inform NICE so when HTM01-05 version 4 comes out in 2011, it will SYNERGISE and enhance everything that occurs around patient care, not detract or interrupt it unduly.
That would be the positive way forward to help turn this "Ugly Duckling" into a "Beautiful Swan" that the whole profession could welcome and implement realistically, knowing that overall there was proven patient benefit.
Let us hope the DH can show such strength, this would be in the best interests of the public, ultimately.
(This document may be downloaded here).
HTM 0105
Excellent presentation at BDA Conference. Evidence backed common sense! Thanks for that. BDA should have scheduled it for main arena and encouraged every delegate to attend, rather than have it clash with Lord Howe's presentation.Start Writing.
Now they've started work, it's time to start writing letters.I've written to my (new) MP today, and enclosed a copy of this article.
New Government - a listening one this time?
Dear All,I do think with a new Liberal-Conservative Government looking to cut unnecessary excessive expenditure and protect front-line services to patients, referral to NICE for proper evaluation and impact assessment would meet the national Interest AND benefit patients too.
If you think likewise, it's time to let our new MPs and Health Minister know our deep concerns about HTM01-05 as it stands!
Tony.
as always well thought and written article.
thumbs up for the time you put in to elevate and educate our profession
Excellent
Brilliant, well thought out article.You need to be logged in to leave comments.
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