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A RECENT decision in the NSW Court of Appeal raises concerns for doctors, particularly those practising musculoskeletal medicine.
The decision, which upheld an earlier court judgment against a GP, involved an infection that developed after an injection of cortisone for lateral epicondylitis. The GP was found to be negligent on the basis that the original judge said he believed the evidence of the patient over that of the doctor.
The patient said the doctor touched the sterile area prior to injecting and that had caused the infection. The doctor gave evidence that he used a clean “no-touch” technique.
The GP appealed against the original judgment but in a 2:1 decision the Appeal Court upheld that decision.
The issue that most concerns me and the Australian Association of Musculoskeletal Medicine is that the original judge was swayed by evidence from experts who suggested the doctor should have been wearing sterile gloves and gown and disinfected the skin.
This is astounding. The idea that GPs — or any doctor — giving an injection for lateral epicondylitis should be both gowned and gloved is a nonsense.
GPs are going to become deskilled if this case sets a precedent. Most legal minds are of the opinion that this one case won’t mean a change in practice but we need to make sure it doesn’t. We need to raise our voices.
There is no real evidence which supports the use of a fully sterile technique for these injections. Doctors of all kinds — GPs, rheumatologists, orthopaedic surgeons and sports physicians — have used the “no-touch” clean technique for decades without a significant rate of infections. This case appears to be the exception worldwide.
In 2001, Professor Chris Del Mar and colleagues writing in the MJA (2001; 174: 306) suggested that even isopropyl alcohol swabbing prior to injecting was unnecessary. There was also a report in The Lancet in 1969 highlighting the fact that in a trial of more than 5000 injections of all kinds, including intravenous injections — without prior swabbing — not one case of infection occurred.
There are other issues in the case which should concern any doctor going into court — such as not being able to get your point of view across. Those other issues should motivate doctors to read the transcript, but the main concern is the issue of sterile gowns and gloves.
If this were to be adopted as standard care, patients would soon find that their GP had ceased performing injections or that the cost to the patient would rise enormously. To be gowned and gloved you would then need a third person in the room to hand over the sterile syringe. Who is going to pay for this?
The possibility of a change from the “no-touch” technique raises the issue of vaccination techniques used in schools, phlebotomy and even self-injecting rooms. Where does it end?
The AMA and the Royal Australian College of General Practitioners have been alerted to the need for some attention to this matter and it appears that the issue will be raised on the agenda of the next meeting of the Committee of Presidents of Medical Colleges.
The profession must stand up and be heard. If there is a forced change in injection practice the consequences could be far reaching.
Dr Geoff Harding is the president of the Australian Association of Musculoskeletal Medicine and practises musculoskeletal medicine full-time in Brisbane.
Posted 4 July 2011
many doctors do not in fact decontaminate the skin. they wipe the area quickly with alcohol and inject while it is still wet.
In reply to Matthias Maiwald, I should point out that I would never advocate that skin is not sterilised prior to any injection – I think we should take all practical precautions when injecting. I quoted Del Mar simply to highlight the seemingly low risk of infection occurring even when skin is not sterilised prior to penetrating the skin. And whilst I agree that the focus of the case was on whether or not the doctor touched a sterile area prior to injecting, the implication from some of the evidence was that gowns and gloves should be used. My purpose was to plea that this not be taken up as the norm.
There a few things to consider when reading Dr Harding’s article. First, it is indeed neither standard practice nor does it appear to be necessary to do sterile gowning and gloving when giving a simple injection into soft tissue. Second, the court decision does not appear to be focusing much on the gowning and gloving issue, according to the court document and the linked Avant document. Instead, the major focus (also that of the experts) was whether the doctor re-touched and re-contaminated an already disinfected skin area. If this is what happened and if it can be verified, then it is undoubtedly a breach of appropriate medical practice and duty of care.
Third, corticosteroid injections (anecdotally) do indeed appear to be associated with a higher than usual risk of infection, presumably because the agent knocks out the local immune response at the injection site, so that a lower bacterial inoculum can initiate/precipitate infection.
Fourth, Dr Harding is incorrect when he dismisses the need for skin disinfection for such injections. The 2001 MJA article by Del Mar is cited. I have reviewed this article on a previous occasion and communicated serious concerns about it within the Australian infection control community. It examines three published reports, one on subcutaneous injections in about 14 diabetic patients, two on venipuncture in about 300-400 patients in total (from memory). Not even a single IM injection is reviewed in the Del Mar article, and yet it attempts to draw conclusions pertaining to ALL types of injections, including IM. That is clearly not a valid conclusion from the evidence examined. Also, infections after injections are undoubtedly rare, but they are very well described (in most classical textbooks), and there is a well-established causal relationship between skin organisms and infections, including an inverse relationship between risk of infections and the amount of reduction by skin disinfection. Again, these infections are rare, and exact data on their frequency are lacking, but according to expert estimates there may be one infection in about 5,000-10,000 injections. When studying only a few hundred patients (again, none IM), such as in the Del Mar paper, and the natural frequency of the event occurring is about 1:5000 (or less frequent), would anyone believe that one would be able to gather valid evidence pertaining to the question from such an analysis? The 1969 Lancet paper by Dann is similarly flawed and the author clearly does not understand the underlying concepts (e.g. writes something about “sterilising” the skin, which is clearly outside the concept of skin antisepsis).
Fifth, the recommendation to disinfect skin only when visibly dirty (as has been stated by some authors) is also clearly misguided. While it sounds superficially appealing, there is no scientific or any other basis for making such a distinction in the form of a cutoff. Microorganisms are invisible, that is their nature.
Sixth, a colleague from Switzerland has pointed out to me that there was a similar court case in the mid-1990s of infection after corticosteroid injection, and the doctor was convicted because skin disinfection had been omitted.
“Despite the view of Associate Professor Eisen that the bacteria arose from a gastrointestinal source there was no medical evidence that supported this finding and the weight of the medical evidence supported a finding that the plaintiff contracted the infection when the defendant injected her with cortisone in November.
“… it is apparent that he meant there was no evidence of signs or symptoms of the infection that the respondent contracted coming from the gastrointestinal tract. For that reason, there was no evidence to support Associate Professor Eisen’s view.”
Is this ridiculous or what? They dismissed the ID physician’s opinion that the bug came from the GI tract, because the patient had no symptoms of gastro? Did these people go to medical school? Oh hang on…
This is absurd. Means all phlebotomies and I-V cannulations need to be gloved and gowned
I am absolutely horrified with the manner in which one of our colleagues has been dealt with by the courts. Every medical practitioner should read the detail contained in the decision, and be wary of the smug subjectivity of our legal counterparts. The input from the expert witnesses should also be a warning that there will be some of our colleagues equally willing to hang us out to dry… A depressing and very sobering read, indeed.