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October 2000
MANUFACTURER/ SUPPLIER
Generic
PROBLEM
MDA continues to receive reports of the ignition of traces of spirit-based fluids during electrosurgical procedures; the fluids are mainly for skin cleaning/preparation. The resulting flames have led to serious patient burns, either directly or by setting light to flammable materials.
For attention by:
Health Authorities (England) - Chief Executives
NHS Trusts (England) - Chief Executives
Primary Care Trusts (England) - Chief Executives
ACTION
If spirit based skin preparations are used in the presence of electrosurgical equipment, surgeons must ensure:
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that the preparation is given adequate time to dry or the skin is dried with a surgical swab;
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that there is no pooling of the preparation e.g. underneath the drapes, in the patient's umbilicus etc.
In order to eliminate the risk of fire or burns, surgeons should consider the use of aqueous based skin preparations when electrosurgery equipment is to be used, bearing in mind that these will generally require a longer drying time to be effective. Furthermore, no other source of spirit should be introduced to the operative field during surgery e.g. when suture packages are opened.
Consideration should be given to labelling containers of spirit-based skin cleaning and preparation fluids with a cautionary statement such as: CAUTION: THIS PREPARATION CONTAINS SPIRIT. WHEN USE IS TO BE FOLLOWED BY SURGICAL DIATHERMY, DO NOT ALLOW POOLING OF THE FLUID TO OCCUR AND ENSURE THAT THE FLUID HAS EVAPORATED FROM THE SKIN AND SURROUNDING AREAS.
DISTRIBUTION REQUIRED
Please bring this notice to the attention of all who need to know or be aware of it. This will include distribution by:
TRUSTS to:
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Liaison Officers (for onward distribution)
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Medical Directors
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Nursing Directors
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Surgeons
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Anaesthetists
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Theatre Managers and Operating Room Staff
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Pharmacists
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Supplies Officers
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Risk Managers
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Nurse Executive Directors
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Control of Infection Doctors
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Infection Control Nurses
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Chairs of Infection Control Committees
HEALTH AUTHORITIES to:
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Liaison Officers (for onward distribution)
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Chairs of Primary Care Groups
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Registration Inspection Units
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General Medical Practitioners
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General Dental Practitioners
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Practice Nurses
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Private Hospitals
PRIMARY CARE TRUSTS to:
BACKGROUND
1. This notice replaces the guidance given in SIB (85)14 of March 1985 and HC(Hazard) (90)25 of 19 June 1990 on the same topic which were both recently withdrawn.
2. During surgical diathermy it is quite normal for some sparking to occur at the active electrode. These sparks are able to ignite the vapour from spirit-based cleaning or preparation fluids, which have low ignition temperatures.
3. Even when the fluid has apparently evaporated it is possible for spirit vapour to remain pooled on or under surgical drapes.
4. Over the years a number of instances have been reported to MDA in which spirit-based fluids have ignited during electrosurgical procedures and led to injuries. Such reports continue to occur due to continued use of spirit-based preparations by some establishments.
5. In response to continued resistance to the use of preparations which are not spirit-based, MDA has consulted widely on this topic. We have been assured by The Medicines Control Agency that all such products licensed for use in the UK have evidence that they are effective; therefore when used in accordance with the manufacturers' instructions all such preparations on the UK market will be suitable for their declared purpose.
6. Recently a case was reported where spirit spilled from a suture pack when it was opened, leading to ignition. Anecdotal evidence also calls for caution when using sprays which have flammable propellants such as butane, for similar reasons.
ENQUIRIES
Queries about the spirit content of skin cleaning and preparation fluids, including hospital manufactured products, should be addressed in the first instance to the relevant hospital pharmacy department.
Enquiries to the MHRA should quote reference number 20000128.010-1.
© Crown Copyright 2000