Hospitals and health care systems utilize numerous consumable medical products and devices manufactured, sterilized and distributed by manufacturers. Disposable device manufacturing is a relatively new industry with its creation due largely to the discovery of plastics and ethylene oxide gas sterilization. This industry has expanded quickly and dramatically by providing convenient, accessible medical products and devices. The products and devices are, for the most part, labeled disposable, one-time use or single-use, as determined by the manufacturer.

The health care facility supply stream has evolved from essentially 100% reusable in the 1950s to predominantly disposable or single-use products and devices in the 1990s. This has contributed to the growth of supply costs for hospitals and health care systems which equals routinely 40 – 50% of total expense--- a significant portion of a facility’s operating budget.

With the continued pressure on health care facilities to reduce costs, practices such as reuse, resterilization and reprocessing are on the increase. Additionally, facilities are implementing strategies to reduce both the initial expense of products and medical devices and to reduce the volume of waste generated and, therefore, costs associated with waste treatment and disposal.

The American Society for Healthcare Central Service Professionals (ASHCSP) of the American Hospital Association (AHA) does not condone or denounce the practice of reuse, resterilization or reprocessing of disposable or single-use medical devices. ASHCSP issued a statement in 1986 on the reuse issue, revised it with AHA in 1990, and distributed a technical advisory bulletin to all member hospitals. More recently, ASHCSP and AHA issued a quality advisory on December 5, 1997.

ASHCSP realizes the complexity of the issues surrounding reuse, resterilization and reprocessing and respects the diverse needs of health care facilities. As such, ASHCSP believes the decisions to reuse, resterilize and reprocess are the responsibility of each individual hospital or health care system.

Terminology and Categories For discussion purposes within the context of this paper, the following terminology is defined:

Reuse: the cleaning, packaging and sterilization of a single-use medical device after use on a patient for the intended purpose of using it on another patient.
Resterilization: the sterilization of an unopened sterile device placed inside a pack or tray along with other devices. This would also apply for dated items where the expiration date does not relate to product deterioration or drug potency.
Reprocessing: the packaging and sterilization of a device that has been opened, but not used on a patient.

Additionally, the following medical categories are defined:

Critical: a device that will penetrate a sterile tissue plane during use, i.e. invasive devices for diagnostic purposes, implantable devices or components of heart-lung oxygenator.
Semi-critical: a device that will not penetrate a sterile tissue plane, but will touch or enter mucus membrane during use, i.e. breathing circuits and other respiratory devices and endoscopes.
Non-critical: a device that will not penetrate a sterile tissue plane or mucus membrane during use, but may touch the patient’s intact skin, i.e. blood pressure cuffs, oxygen masks, skin staple removers and restraints.
Decision Process

Health care facilities should appoint a multi-disciplinary committee to develop policies and practices relating to reuse, resterilization, and reprocessing. ASHCSP recommends the committee include representation from the following disciplines: infection control; central service; perioperative services; risk management; materials management; administration; ethics; and medical staff.

Furthermore, ASHCSP recommends the committee’s work include:



Establish a comprehensive program which includes policies and procedures to govern the multi-disciplinary committee’s decision processes for determining the reuse, resterilization and reprocessing status of medical devices and categories of medical devices.



Develop an evaluation process to review and award outsourcing contracts for reuse, resterilization or reprocessing.



Develop and implement an evaluation process to solicit review and approval or disapproval of reuse, resterilization or reprocessing requests from clinical practitioners.



Develop and implement a consistent institutional policy on charging methodologies for single-use devices that are reused, resterilized or reprocessed.



Develop and implement a program to document the evaluation process and to quantify outcomes if decisions support the reuse, resterilization or reprocessing of single-use devices.



Develop protocol for documentation of validation data on the safety and effectiveness of any medical devices reused, resterilized or reprocessed by an outsourced, third party reprocessor.



Identify responsibilities for validation of the process for reuse, resterilization or reprocessing, including but not limited to the following: pyrogen testing, residual testing, form and function testing of the device, etc.



Develop a tracking mechanism from receipt of the original medical device to its final disposal including but not limited to: manufacturer, product number, lot number, and number of uses if more than one.

Conclusion

ASHCSP believes a well-developed and managed program for the reuse, resterilization or reprocessing of single-use devices will include the decisions not to reuse, resterilize or reprocess some devices; internal reuse, resterilization or reprocessing of some devices; and the outsourcing of the reuse, resterilization or reprocessing of some devices. These decisions would be consistent with a thorough evaluation process of individual medical devices and institutional resources. For non-critical medical devices all of the options may be selected, for semi-critical medical devices resterilization or reprocessing may be an option, and for critical medical devices only reprocessing may be an option.

There are a number of resource materials published on this issue which allow health care facilities to make an informed decision on what specific steps are required for their facilities’ process. Reuse, resterilization, and reprocessing of disposable or single-use medical device protocol must be developed to ensure no greater risk to patients exists than in the use of medical devices marked reusable.

Contact: Kathy Svedman Via e-mail at: ksvedma1@aha.org or call 312-422-3861