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National Protocols and Quality Assurance Systems

30 May 2000

National Protocols and Quality Assurance Systems Proposed

THE Ministry of Health and the Health Funding Authority will be working with hospitals on developing national protocols and quality assurance systems for cleaning and reprocessing endoscopes, following incidents in Rotorua and Christchurch.

The move comes two weeks after the Ministry of Health sought confirmation from public and private hospitals that adequate procedures were in place to clean, disinfect and sterilise endoscopes before reuse. The letters were sent after Lakeland Health in Rotorua reported a repeated sterilisation failure of one colonoscope. Canterbury Health had similar problems in July last year.

A colonoscope is a type of endoscope which is inserted into the lower bowel for internal investigations. Only some hospitals perform this procedure.

Chief Advisor Safety and Regulation, Dr Bob Boyd said that the Ministry had received assurances from hospitals that endoscopes are being routinely microbiological tested as a check on the disinfection process.

The Ministry advised hospitals that unless there was a process of systematically testing endoscopes for microbiological contamination, they should not be used.

"The only exception to this is an urgent clinical situation and if that occurs, the patient must be informed that the equipment may not be sterile."

Dr Boyd said this issue had raised questions about the need for a consistent approach for processing and monitoring these instruments.

"Agreed national protocols and quality assurance systems would reduce the risk to patients from potential infection through contaminated equipment. They would also ensure that hospitals meet the new infection control standards, which are close to being finalised."

"Recently developed Australian guidelines, "Infection Control in Endoscopy" and "Standards for Endoscopic Facilities and Services" could be adapted to meet the New Zealand situation."

Dr Boyd said despite extensive investigations the cause of the fault at Lakeland Health is still unclear.

"I accompanied representatives of the STERIS Corporation, which makes the endoscope sterilising equipment used at Rotorua, on a visit to the hospital and observed the sterilisation system in use. The Ministry of Health is satisfied that Rotorua Hospital has the necessary equipment, and its staff have the requisite knowledge and skills to safely reprocess and monitor its endoscopes."

"Contrary to certain media reports, the Ministry has not advised hospitals to discontinue using the STERIS System 1 and related accessories. However, it has asked hospital to ensure staff fully understand and follow all cleaning instructions provided by both the endoscope manufacturer and STERIS Corporation."

Dr Boyd said the Ministry of Health and Health Funding Authority appreciated that STERIS has volunteered to visit all sites where the STERIS System 1 processor is used to ensure hospitals understand, and are following the instructions for use.


For more information contact: Selina Gentry, Media Advisor, ph: 04-496-2483 or 025-277-5411 Internet address:

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