Buenisimo

304

Gut 1998;42:304–306

Working party report
Report of the Working Party of the Endoscopy Committee of
the British Society of Gastroenterology on the reuse of
endoscopic accessories
History and regulatory position
There is a long tradition in the UK of reusing all endoscopic
accessories until they break or are degraded
to an unusable extent, regardless of manufacturers’recommendations. This has stemmed largely from a desire to
eke out the meagre funds generally allotted to gastroenterology/endoscopy departments for equipment.
This attitude has been changing gradually, with the increasing sale of single use items, for example, varices injection
needles, but the scene has been changed completely since
the publication of the Medical Devices Agency Bulletin,
MDA DB 9501, inJanuary 19951 and the implementation
of the European Medical Devices Directive.2
The former bulletin states that products labelled as single use: “...should not be reprocessed and reused unless the
reprocessor:
+ is able to apply and observe all the stringent technical
requirements necessary to ensure the integrity and
safety in use of each reprocessed item;
+ can produce documentary proofand evidence of
successful validation studies of the reprocessing operation. These studies are for the purpose of confirming
that the reprocessing method chosen produces a safe
and eVective product, fit for the intended purpose; and
+ has a system for retaining full reprocessing batch
records, for subsequent retrieval in the event of device
failure and patient injury.
Users who disregardthis information and prepare
single use products for further use, without due precautions, may be transferring legal liability for the
safe performance of the product from the manufacturer to themselves, or to the organisation that
employs them.”
The EEC document examined the whole question of the
suitability of medical devices for their purposes and promulgated the system of CE marking whichhas been
implemented from 1 January 1995 and, following a transition period, will be mandatory from 14 June 1998. This
directive refers in Annex IX, 1.3 to a reusable surgical
instrument as one: “which can be reused after appropriate
procedures have been carried out”. Where the device has
been supplied as a reusable item, the label must bear the
following particulars:
“13.6 (h) if the deviceis reusable, information on the
appropriate processes to allow reuse, including cleaning,
disinfection, packaging and, where appropriate, the
method of sterilisation of the device to be resterilised, and
any restrictions on the number of reuses.
Where devices are supplied with the intention that they
be sterilised before use, the instructions for cleaning and
sterilisation must be suchthat, if correctly followed, the
device will still comply with the requirements in Section I.”
Section I states:
“The devices must be designed and manufactured in
such a way that, when used under the conditions and for
the purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety and

health of users or, where applicable, other persons,provided that any risks that may be associated with their
use constitute acceptable risks when weighed against the
benefits to the patient and are compatible with a high level
of protection of health and safety.”
Reprocessing of single use items without taking due
regard of these documents, may place an individual or the
organisation for whom they work, or both, at risk of prosecution under theliability provisions of Part 1 of the Consumer Protection Act 1987 if the product is found to be
defective (that is, does not provide the expected level of
safety) and may be committing a criminal oVence under
the Health and Safety at Work Act 1974 by contravening
the provisions relating to “general duties” by carrying out
activities which expose patients or staV to risk.
Worries about the...