BACKGROUND: Concern is increasing regarding the risk of transmission of blood-borne pathogens by means of improperly reprocessed medical devices. METHODS: On-site surveys of policies and practices were performed in 18 reprocessing areas in eight randomly selected hospitals in Massachusetts to assess current practices for reprocessing of flexible fiberoptic endoscopes. Manufacturers' and internal written protocols, were reviewed, employees were interviewed, and procedures were observed. Reprocessing included high-level disinfection in 17 of 18 areas, with 16 areas using 2% glutaraldehyde; ethylene oxide gas sterilization was used in one area. RESULTS: Considerable interhospital and intrahospital variability was found in high-level disinfection procedures, including equipment, contact time (range 10 to 45 minutes), disinfectant testing, and rinsing. Disinfection of internal channels was inadequate in three areas, recommended sterilization of biopsy forceps was not performed in five, and written protocols were unavailable in three. Ad hoc deviation from established written or verbal protocols occurred in eight areas during reprocessing of flexible fiberoptic endoscopes from patients known to have AIDS; ethylene oxide sterilization was used in seven areas and a separate device was used in one. Interviews with personnel revealed that lack of knowledge of high-level disinfection contributed to the discrepancies between policy and practice. CONCLUSIONS: We conclude that reprocessing of flexible fiberoptic endoscopes is inconsistent and potentially ineffective. Knowledge that a flexible fiberoptic endoscope was used for a patient with AIDS influences practice.
BACKGROUND: Concern is increasing regarding the risk of transmission of blood-borne pathogens by means of improperly reprocessed medical devices. METHODS: On-site surveys of policies and practices were performed in 18 reprocessing areas in eight randomly selected hospitals in Massachusetts to assess current practices for reprocessing of flexible fiberoptic endoscopes. Manufacturers' and internal written protocols, were reviewed, employees were interviewed, and procedures were observed. Reprocessing included high-level disinfection in 17 of 18 areas, with 16 areas using 2% glutaraldehyde; ethylene oxide gas sterilization was used in one area. RESULTS: Considerable interhospital and intrahospital variability was found in high-level disinfection procedures, including equipment, contact time (range 10 to 45 minutes), disinfectant testing, and rinsing. Disinfection of internal channels was inadequate in three areas, recommended sterilization of biopsy forceps was not performed in five, and written protocols were unavailable in three. Ad hoc deviation from established written or verbal protocols occurred in eight areas during reprocessing of flexible fiberoptic endoscopes from patients known to have AIDS; ethylene oxide sterilization was used in seven areas and a separate device was used in one. Interviews with personnel revealed that lack of knowledge of high-level disinfection contributed to the discrepancies between policy and practice. CONCLUSIONS: We conclude that reprocessing of flexible fiberoptic endoscopes is inconsistent and potentially ineffective. Knowledge that a flexible fiberoptic endoscope was used for a patient with AIDS influences practice.