March 2000

March SN Contents

Tech News

Standard Defines Optimum Reprocessing of Endoscopic Accessory Instruments

ENDOSCOPIC ACCESSORY INSTRUMENTS (EAIs) are intricate medical devices used to diagnose and treat disease. Most EAIs come into direct contact with sterile areas of the body and care must be taken to ensure that only patient-ready devices are used for each examination. Coiled metal sheaths, pivoting joints, and internal lumens of heat-stable EAIs make visual inspection for cleanliness nearly impossible, and a heat-based process is necessary for sterilization.

Now available to direct the reprocessing of heat-stable EAIs, Standard Practice F 1992 for Reprocessing of Reusable, Heat-Stable Endoscopic Accessory Instruments (EAI) Used with Flexible Endoscopes has been developed by medical specialists in the GI Endoscopes Subcommittee in Committee F04 on Medical and Surgical Materials and Devices.

“Those who use the standard will have a concise reference that outlines a step-by-step procedure for the appropriate reprocessing of heat-stable EAIs,” says subchair David Greenwald, M.D., assistant professor of medicine, Gastroenterology Division, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, N.Y.

The standard practice details procedures for cleaning, sterilization, storage, and functionality testing of reusable heat-stable EAIs designed to be inserted into flexible endoscopes.

Greenwald comments on several benefits to users of F 1992: “While in the past, manufacturers of EAIs have provided reprocessing instructions for their devices and certain professional organizations have produced guidelines that address EAI reprocessing, this document represents a current standardization of the most important issues. The subcommittee believes the presence of a standard will provide significant clarification amongst users of the devices as to how to properly care for such instrumentation. This standard clearly will be important in promoting effective practices in the reprocessing of endoscopic accessory instruments labeled for reuse.”

As each brand, type, and model of heat-stable EAI has a unique design and components, F 1992 is particularly helpful. It carefully presents sections on terminology, reagents, procedure, and rationale, although it is not intended to replace manufacturers’ instructions. An appendix lists descriptions and types of 23 models of reusable, heat-stable EAIs for use with flexible fiberoptic and video gastrointestinal endoscopes.

EAIs covered in F 1992 may or may not have lumens or loosely-joined surfaces, may or may not have access ports for flushing, and may or may not be capable of being completely disassembled prior to reprocessing. “The standard practice is not intended to be applied to the reprocessing of single-use, disposable endoscopic accessory devices specifically designed and labeled as such by their manufacturers,” notes Greenwald. “It is also not intended to address the reprocessing of heat-sensitive EAIs.”

ASTM standards are available through Customer Service (610/832-9585), or through the Web site.

Questions or comments may be directed to David Greenwald, M.D., Gastroenterology Div., Albert Einstein College of Medicine, Montefiore Medical Center, 111 E. 210 St., Bronx, NY 10467 (718/920-4846). Committee F04 meets during ASTM Committee Week, May 24-26, Toronto, Ontario, Canada. For meeting or membership information, contact F04 Staff Manager Teresa Cendrowska, ASTM (610/832-9718). //