Iatrogenic vCJD from surgical instruments
BMJ 2001; 322 doi: https://doi.org/10.1136/bmj.322.7302.1558 (Published 30 June 2001) Cite this as: BMJ 2001;322:1558All rapid responses
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USE OF SURGICAL INSTRUMENTS AND vCJD IN FRANCE.
Authors: D.Roy*F.R.C.S., M. Al Jumailly** F.R.C.S., L. Castillo* M.D.
*Department of ENT, ** Department of Neurosurgery,
University of Nice, Hospital Pasteur, France.
Currently, the prevalence of subclinical vCJD and its degree of
infectivity via surgical instruments are unknown and no cases of
iatrogenic vCJD in humans has so far been identified. The Ministry of
Health,France (1) has given pragmatic guidelines for the use of surgical
instruments. The use of disposable instruments in operations like
tonsillectomy and neurosurgical procedures has been recommended. However,
currently disposable instruments are not being used. So, the guidelines
for reusing the instruments takes into account the :
1. type of operation
2. tissues involved
3. risk level of the patient
4. method of sterilisation.
The patients undergo pre-anaesthetic screening to evaluate high risk
group.
Questionaire includes h/o treatment by extract of Growth Hormone, family
history of vCJD, h/o previous surgery especially neurosurgery procedures
involving the duramater or stereotaxic procedure.
The method of sterilisation is divided into 5 groups. Group 4 and 5 are
recommended.
Group 4 includes:
1. autoclaving with 1M NaOH at 121 degree C for 30 minutes in a gravity
dependent autoclave followed by usual sterilisation
2. submersion in NaOH or Sodium Hypochlorite for 1 hour then autoclaving
at 121 degree C for 1 hour in a gravity dependent autoclave.
Group 5 includes incineration at temperatures above 800 degree C.
Patients who are categorised as high risk or procedures that involve
high risk tissues like tonsils, duramater, the instruments are thoroughly
cleaned to remove all traces of organic material at the washing phase of
the decontamination process (washing, disinfection, and sterilisation) (2)
and sterilised by Group 4 method. If the patient is suspected of having
vCJD, then the instruments are kept aside awaiting diagnosis. If the
diagnosis is confirmed or cannot be confirmed nor rejected then the
instruments are treated by Group 5 and discarded according to the hospital
procedure. If the diagnosis is negative, then the instruments are reused
after sterilisation by Group 4 method.
This practical approach is more sensible way of reusing the surgical
instruments until there is sufficient evidence to warrant the use of
disposable instruments.
REFERENCES
1. The Ministry of Health, France circulaire DGS/DPPR n° 2000/292 dated
may 29th 2000 ‘ Relative à diverses mesures concernant les appareils de
desinfection des déchets d’activités de soins à risques infectieux et
assimilés.’
2. Advisory Committee on Dangerous Pathogens and Spongiform Encephalopathy
Advisory Committee. Transmissible spongiform encephalopathy agents: safe
working and the prevention of infection. London: Stationery Office
Competing interests: No competing interests
The risk of transmission from surgical instruements is, as stated,
unknown. There may, indeed, be no risk at all and the connection of vCJD
to prion protein 'infection' tenuous at best yet the response has been to
create the real risk of morbidity and mortality here and now by
necessitating a change in anaesthetic practice and, as the instruments are
far from satisfactory, compromising surgical care.
The return to routine endotracheal intubation will lead to
previously avoided airway problems in theatre and the recovery area with
additional risks from muscle relaxant drugs.
We are being actively encouraged to identify, profile, assess and
manage the clinical risks of our practice. This is a good example of the
wrong approach.
Competing interests: No competing interests
Editor - In his editorial Forsh supports the use of disposable
instruments for adenotonsillectomy1, on the grounds of substantial
potential risk of transmission of vCJD. I would agree that, until we can
guarantee safety of improved decontamination of reusable instruments, this
is justified. However, I am concerned that the haste with which these
directives have been implemented has lead to the purchase and use of sub-
standard insruments which may increase the risk of post-operative
complications.
- Our unit performed approximately 30 procedures with disposable
insruments in May, the first month that these kits were available. During
this time we have had 2 incidents of primary heamorrhage in children
necessitating return to theatre for arrest of heamorrhage, 1 after
tonsillectomy and the other after adenoidectomy. Both cases were performed
by experienced senior registrars nearing their CCST date, who both
atrributed the blled to problems experienced with the disposable kit. Both
children went on to be discharged without further complications. Of note,
there were no episode of primary heamorrhage in the preceding year using
the old instruments.
- We have noted a number of problems with th disposable kit. The bipolar
forceps lack sufficient strength to prevent buckling and frequent crossing
of the tips, the gag similarly bends under tension, and slips as the
dental guard is not properly attached. The space in the blade of the gag
traps the endotracheal tube leading to unexpected extubation. The adenoid
curette is too flat to allow clean curettage of the adenoid pad. The snare
has failed to work on several occasions.
- We are currently auditing morbidity asociated with disposable
instruments, and I would encourage other units to report similar problems.
Risk management must involve a balance of associated risks. We need better
information with regards to the potential risk of transmission in order to
justify the long-term use of instruments if they are found to increase the
risks of routine surgery.
1 Frosh A Iatrogenic vCJD from surgical instruments BMJ 2001; 322:1558
your sincerely
Claire Hopkins
Specialist Regitrar
clairehopkins@yahoo.com
London W14 9SB
There are no conflicts of interest in this letter
Competing interests: No competing interests
The suggestion to use disposable kits of surgical instruments for
adenotonsillectomy is practical. As the number of instruments used for
these procedures is limited it is possible to develop a cost effective
disposable kit.
There is no denial that tonsillectomy operation, which has been
described as ‘bread and butter’ of ENT Surgeons, still tops the list of
surgical procedures. The number of tonsillectomies has been coming down in
our hospital as we have become very selective in choosing cases for this
procedure.
The risk of iatrogenic transmission of new variant Creutzfeldt-Jakob
disease (vCJD) through adenotonsillectomies can be minimized both through
use of disposable surgical kits and restraint on part of ENT Surgeons. The
indication for these procedures should be clearly defined and only
genuinely indicated cases taken for surgery.
Competing interests: No competing interests
The ethics of assessing new surgical techniques.
The risk of transmission of variant CJD might be reduced by using
disposable surgical instruments. This hypothesis is being tested on a
vulnerable group of patients. Within our own department we have
identified problems such as compression of the endotracheal tube by the
disposable gag and there may be an increase in post operative haemorrhage.
During upper airway surgery these are real complications which can
lead to significant mortality.
My concern is that the use of totally disposable surgical instruments
for tonsillectomy, together with a necessary change of anaesthetic
technique has been introduced to test a hypothesis without external
ethical review.
As far as I am aware no patient or their guardian has given consent
to take part in this study, there is no method to opt out, and there is no
monitoring of complications by the investigators concerned. There is no
choice for the anaesthetists or surgeons to opt out of using this
technique other than to opt out of performing tonsillectomies.
If an existing drug used in a new preparation was to be evaluated,
then this would be subjected to ethical review. Why is this experiment
being undertaken without similar review?
I declare that I have no conflict of interest.
DJM Williams
Competing interests: No competing interests