Section: UTMB On-line Documentation Subject: Healthcare Epidemiology Policies and Procedures Topic: Disposable Patient Care Items

1.7 - Policy 2006 - Revised 1981 - Author

1.7 Disposable Patient Care Items

Purpose	To prevent exposure of patients and staff to unsafe patient care items
Audience	All employees of UTMB hospitals and clinics, contract workers, volunteers, and students
Policy	All medical devices labeled “single-use” or “disposable” that have exceeded their expiration date, been opened but not used, or have been used or contaminated must be discarded unless reprocessed by an insured, FDA-registered third party reprocessor approved by the Hospital Epidemiologist.
Standards for Third Party Reprocessors	UTMB shall conduct an extensive on site evaluation of reprocessing procedures by third party reprocessors. • Single use or disposable medical devices may be reprocessed only by manufactures that are under contract with UTMB to provide reprocessing services. The legal department must review all contracts between UTMB and device reprocessors. • The Hospital Epidemiologist must evaluate prospective reprocessing companies to determine whether procedures used for reprocessing are scientifically valid and will provide products that are safe for reuse. • Sterilization monitoring must meet or exceed the standards set forth by the general compliance document AAMI/ANSI/ISO 11135-1994: Medical devices and all ensuing amendments to the document. • Only devices sent by UTMB to the reprocessor will be returned to UTMB. • The reprocessor must maintain accurate records of products received, reprocessed, sterilized and returned to UTMB for five (5) years.
Monitoring	• Any and all observations, problems, or occurrences resulting from the use of a reprocessed device will be documented and reported to the Department of Healthcare Epidemiology.