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.

Inclusions

This recommended practice specifically addresses

a) design criteria for functional work areas involved with the receiving, staging, and handling of soiled surgical textiles; the separation of soiled and clean textiles; the laundering of reusable surgical textiles; and the inspection and preparation of clean bulk items and surgical textile packs;

b) staff qualifications, education, training, dress codes, and other personnel considerations;

c) transporting, receiving, and handling of both newly purchased and soiled surgical textiles;

d) laundry processing (loading, washing, drying) recommendations;

e) inspection, testing, and maintenance of laundered textiles;

f) preparation and packaging of laundered textiles;

g) handling, transport, and storage of laundered textiles;

h) installation, operation, care, and maintenance of laundry equipment;

i) quality control measures, procedures, and practices;

j) medical device regulatory considerations.

Definitions of terms and a bibliography are also provided in this recommended practice.

Exclusions

This recommended practice does not cover

a) design or construction criteria for equipment used to process reusable surgical textiles;

NOTE-Performance requirements for washer-disinfectors are provided in ISO 15883-1, 15883-2, and 15883-3. Performance requirements for hospital steam sterilizers are provided in ANSI/AAMI ST8.

b) the application of any sterilization technology or sterility assurance practices;

NOTE-Detailed guidance on steam sterilization and sterility assurance in health care facilities is provided in ANSI/AAMI ST79. Guidance on steam sterilization in health care facilities is also provided in ANSI/AAMI/ISO 17665-1, which addresses industrial steam sterilization as well. ANSI/AAMI ST41 addresses ethylene oxide sterilization and sterility assurance, and ANSI/AAMI ST40 provides guidelines on dry heat sterilization.

c) selection of reusable surgical textiles (see AAMI TIR11);

d) performance standards for reusable surgical textiles (see ANSI/AAMI PB70);

e) surgical textiles labeled for single use.