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BMJ. 2001 June 30; 322(7302): 1558–1559.
PMCID: PMC1120609
Iatrogenic vCJD from surgical instruments
The risk is unknown, but improved decontamination will help reduce the risk
Adam Frosh, consultant ENT surgeon
Lister Hospital, Stevenage, Herts SG1 4AB (Email: a.frosh/at/btinernet.com)
Rachel Joyce, senior registrar, public health medicine
South Thames Public Health Rotation, St George's Hospital, London SW17 0RE
Alan Johnson, consultant ENT surgeon and honorary secretary
British Association of Otorhinolaryngologists-Head and Neck Surgeons (BAOHNS), Royal College of Surgeons of England, London WC2A 3PE
Because of fears about iatrogenic transmission of new variant Creutzfeldt-Jakob disease (vCJD), the Department of Health recently announced fundamental changes in surgical practice, and in particular the practice of ear, nose, and throat surgery. Decontamination facilities in hospitals are to be upgraded, and by the end of 2001 all adenotonsillectomy procedures will be performed using disposable instruments.1 Why are these measures necessary?
At present both the prevalence of subclinical vCJD and its degree of infectivity via surgical instruments are unknown. Also, no cases of iatrogenic vCJD in humans have so far been identified. Nevertheless, based on the evidence we do have, we can make judgments about the features that are likely to affect the size of the risk from surgical instruments.
So far the disease marker (and likely transmissible agent) for vCJD (PrPSc) has been identified by sensitive western blot techniques in the neural and lymphoreticular tissues of brain, tonsil, and spleen.2 A positive appendix (which consists largely of lymphoreticular tissue) has not yet been reported using this technique, though one archived appendix has been reported to be positive using immunohistochemical staining.3
There is clear evidence from case reports in humans and animal models that prion diseases can be transmitted via stainless steel instruments.4,5 Also the infective agent of iatrogenic prion diseases has shown remarkable resistance to the conventional sterilisation techniques used for surgical instruments.6 The incubation period of vCJD is unknown but could be several decades,7 so it is therefore unlikely that any iatrogenic cases will have yet emerged. The precautionary principle suggests that when the potential risk to public health is substantial there is no case for sitting back to wait for indisputable evidence. This view has influenced the British government's previous decision to leucodeplete all blood and blood products.8
So what is the purpose of the new policy to upgrade decontamination facilities?
The most effective generic approach to preventing vCJD transmission is thought to be to remove all traces of organic material at the washing phase of the decontamination process (washing, disinfection, and sterilisation).6 Some decontamination facilities in British hospitals are relatively old, and upgrading them should enable more effective decontamination. This should reduce the risk of transmission of vCJD and of other (including unknown) diseases. Measures are also being introduced to enable all reusable surgical instrument sets to be traced.9
Why won't these general measures do for adenotonsillectomy and why must this procedure, specifically, be performed with disposable instruments? We know through animal models that PrPSc becomes positive in lymphoreticular tissues relatively early in the incubation period.10 The population undergoing adenotonsillectomy is young (median age 9 years) and has a further life expectancy of about 65 years. Even if vCJD has an incubation period of several decades, the potential impact of iatrogenic transmission to children is particularly serious. Tonsillectomy and adenoidectomy are common operations (about 69 000 were performed in the UK in 1999-200111). The instrument sets are reused often, and their time in service often exceeds 10 years. Therefore, each set of instruments will over its lifetime have come into contact with many patients, significantly increasing the risk of contamination. In this situation, even if the relative risk is low, the population attributable risk is probably high. This attributable risk reflects the potential numbers of patients who could be affected. If the prevalence of preclinical disease is, say, 1 in 10 000, then about 30% of ear, nose, and throat units could have a contaminated instrument set in the operating theatre.12 This risk is likely to be increased as instruments tend to “wander” across to other instrument sets with time.
By contrast, patients undergoing lymph node excisions and neurosurgery are usually older and have generally shorter life expectancies. PrPSc is expressed in neural tissue relatively late in the incubation period, and neurosurgical operations are performed on fewer patients. Compared with the population undergoing adenotonsillectomy, these patients are likely to have a lower attributable risk.
The case for disposable instruments in appendicectomy remains less clear. So far, the evidence that the appendix is a reliable site for abnormal prion expression is weaker than for tonsils, with only a single case reported with positive immunohistochemistry. However, this operation shares many of the risk attributes of tonsillectomy in that the patient population is otherwise healthy and young and the operation is common.
The Department of Health has worked closely with the British Association of Otorhinolaryngologists-Head and Neck Surgeons to determine the feasibility of using disposable instruments for adenotonsillectomy and in implementing the changes. Although we cannot guarantee that the likely transmissible agent of vCJD will be completely eliminated by the proposed changes in decontamination of surgical instruments, any improvement on the present system is likely to reduce the potential infectious load. If the infectivity is dose related, then this generic approach, together with the specific use of disposable instruments for adenotonsillectomy, should reduce the attributable risk to the population, and is therefore welcome.
Footnotes
 AF was involved in developing the Exmoor disposable tonsillectomy kit, originally designed to confirm diagnosis of clinically suspected cases of vCJD in living patients by tonsil biopsy.
1. Department of Health. £200 million for NHS equipment to protect patients against possible variant CJD risk. London: DoH; 2001. (press release 2001/0012).
2. Hill AF, Butterworth RJ, Joiner S, Jackson G, Rosser MN, Thomas DJ, et al. Investigation of variant Creutzfeldt-Jakob disease and other human prion diseases with tonsil biopsy samples. Lancet. 1999;353:183–189. [PubMed]
3. Hilton D, Fathers E, Edwards P, Ironside J, Zajicek J. Prion immunoreactivity in appendix before clinical onset of variant Creutzfeldt-Jakob disease. Lancet. 1998;352:703–704. [PubMed]
4. Bernoulli C, Siegfried J, Baumgartner G, Regli F, Rabinowicz T, Gajdusek DC, et al. Danger of accidental person-to-person transmission of Creutzfeldt-Jakob disease by surgery. Lancet. 1977;1:478–479. [PubMed]
5. Zobeley E, Flechsig E, Corrizio A, Enari M, Weissman C. Infectivity of scrapie prions bound to a stainless steel surface. Mol Med. 1999;5:240–243. [PubMed]
6. Advisory Committee on Dangerous Pathogens and Spongiform Encephalopathy Advisory Committee. Transmissible spongiform encephalopathy agents: safe working and the prevention of infection. London: Stationery Office; 1998.
7. Collinge J. Variant Creutzfeldt-Jakob disease. Lancet. 1999;354:317–323. [PubMed]
8. Horton R. The new new public health of risk and radical engagement. Lancet. 1998;352:251–252. [PubMed]
9. Department of Health. Decontamination of medical devices. Health Service Circular 2000/032.
10. Fraser H, Bruce M, Davies D, Farguhar C, McBride P. The lymphoreticular system in the pathogenesis of scrapie. In: Prusiner S, Collinge J, Powell J, Anderton B, editors. Prion diseases of humans and animals. London: Ellis Horwood; 1992. pp. 308–317.
11. Department of Health. Hospital in-patient data based on hospital episode statistics, England 1999/00. http://www.doh.gov.uk/hes/standard_data/available_tables/main_operations/index.html. 2000.
12. Frosh A. Prions and the ENT surgeon. J Laryngology Otology. 1999;113:1064–1067. [PubMed]

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