[1] Recommended Practices for Selection and Use of Packaging Systems - 1

AORN Journal, Dec, 2000

Editor's note: The AORN recommended practices (RPs) are written by a standing committee of the Association composed of AORN members and liaisons from the Centers for Disease Control and Prevention, the Association for Professionals in Infection Control and Epidemiology, the American Society of Healthcare Central Service Professionals, the international Association of Healthcare Central Service Materiel Management, the American College of Surgeons, and the American Society of Anesthesiologists. Each recommended practice is reviewed and revised as appropriate at regular periodic intervals.

In 1998, AORN members asked the Recommended Practices Committee to develop a more user-friendly and less repetitious format for the RPs. After careful consideration of several possible formats, the committee selected the format they believed would best meet the member's criteria. The committee then asked AORN members to compare this proposed format to the present RP format and to register a preference for future RPs. Staff members in the Center for Nursing Practice at AORN assisted the committee by soliciting feedback via the AORN web site and individual mailings to a sample of the AORN membership. The overwhelming preference was for the new and improved format, and in 1999, the AORN Board of Directors approved the new format for publication. Since the AORN Board of Directors' approval, nurses in the Center for Nursing Practice have been converting the ex/sting RPs to this format. Watch for the new look in the 2001 edition of AORN's Standards, Recommended Practices, end Guidelines.

The following RP is the first in a series of RPs to be published in the new format. It is the committee's hope that this format will better meet member needs and allow for easier implementation in the practice setting.

The following recommended practices were developed by the AORN Recommended Practices Committee and have been approved by the AORN Board of Directors. They were presented as proposed recommended practices for comments by members and others. They are effective Jan 1, 2001.

These recommended practices are intended as achievable recommendations representing what is believed to be an optimal level of practice. Policies and procedures will reflect variations in practice settings and/or clinical situations that determine the degree to which the recommended practices can be implemented.

AORN recognizes the numerous types of settings in which perioperative nurses practice. These recommended practices are intended as guidelines adaptable to various practice settings. These practice settings include traditional ORs, ambulatory surgery units, physicians' offices, cardiac catheterization suites, endoscopy suites, radiology departments, and all other areas where operative and other invasive procedures may be performed.

Purpose: These recommended practices provide guidelines for evaluation, selection, and use of packaging systems for items to be sterilized. These packaging systems include woven fabrics, non-woven materials, peel pouches of plastic and/or paper, and container systems. Packaging systems should ensure sterility of package contents until opened for use and should permit removal of contents without contamination.

RECOMMENDED PRACTICE I

Packaging systems should be evaluated according to the AORN "Recommended practices for the evaluation and selection of products and medical devices used in perioperative practice settings."(1)

1. Packaging systems should

* be appropriate to item(s) being sterilized (ie, permit identification of contents; permit complete and secured enclosure of item(s); protect package contents from physical damage; resist tears, punctures, and abrasions; be free of holes; be free of toxic ingredients; be low-linting; permit delivery of contents without contamination; maintain sterility of package contents until opened);

* be appropriate to the method of sterilization (ie, provide adequate seal integrity; be tamperproof and able to seal only once; provide an adequate barrier to particulate matter and fluids; be compatible with and able to withstand physical conditions of the sterilization process; permit adequate air removal; allow penetration and removal of sterilant);

* have a favorable cost/benefit ratio; and

* be used according to manufacturers' instructions.(2)

2. Each facility should evaluate and test the performance of each packaging system before selection and implementation to ensure conditions for sterilization, storage, and handling can be met.

RECOMMENDED PRACTICE II

Packaging systems should be compatible with the sterilization process.

1. Packaging systems for steam sterilization should

* provide adequate air removal,

* permit steam penetration and direct contact with item(s) surfaces,

* permit adequate drying,

* permit use of material compatible (ie, nondegradable) with the sterilization process, and

* maintain the integrity of the system.

The purpose of packaging systems is to permit sterilization of the package contents, maintain sterility of the contents until the package is opened, and permit delivery of contents without contamination.(3)