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Report of the Working Party of the Endoscopy Committee of the British Society of Gastroenterology on the reuse of endoscopic accessories
  1. M WILKINSON ,
  2. N SIMMONS
  1. M BRAMBLE
  1. R LEICESTER
  1. J D’SILVA
  1. R BOYS
  1. R GRAY
  1. Guy’s Hospital, London SE1 9RT, UK
  2. Middlesborough General Hospital, Cleveland TS5 5AZ, UK
  3. St George’s Hospital, London SW17 ORE, UK
  4. Endoscopy Unit, Rotherham General Hospital Trust, Rotherham S60 1UD, UK
  5. Cook UK Limited, Hertfordshire SG6 1LN, UK
  6. Keymed, Essex SS2 5QH, UK
  1. Dr Wilkinson.

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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, in January 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 proof and 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 effective 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 disregard this 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 which has 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: …

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