scope:

General

This recommended practice provides guidelines for properly handling, processing, and preparing reusable surgical textiles for use in health care facilities. These guidelines describe a quality assurance program for the processing of reusable surgical textiles, including processes and techniques for the preparation of clean bulk items for delivery to user sites and the assembly of textile packs for sterilization prior to end use. These guidelines apply to all facilities that process surgical textiles, whether on-premise laundries (OPLs), hospital-owned cooperatives, or commercial facilities.

NOTE 1-Surgical textiles labeled for single use only should not be reprocessed or reused, because it may not be possible to adequately reprocess them and maintain their performance and safety attributes. In addition, the health care facility's liability may be affected if the manufacturer's written instructions for use are not followed. See also FDA regulations applicable to the reprocessing of single-use medical devices (www.fda.gov/cdrh/reprocessing/).

NOTE 2-For purposes of this recommended practice, "health care facility" means hospitals, nursing homes, extended care facilities, freestanding surgical centers, clinics, and medical, surgical, and dental offices. For convenience, the term "hospital" is sometimes used in this recommended practice; in all instances, the term should be taken to encompass all other health care facilities.