AORN offers advice on reprocessing
AORN offers advice on reprocessing
[Editor’s note: To help our readers, Same-Day Surgery is printing advice in the top 10 areas that receive the most questions at the Center for Nursing Practice, Research, and Health Policy at the Association of Operating Room Nurses (AORN) in Denver. The fourth topic, addressed in this issue, is reprocessing. (See related story, p. 119.)]
By Dorothy M. Fogg, RN, MA
Perioperative Nurse Specialist
Center for Nursing Practice
Association of Operating Room Nurses, Denver
Reprocessing disposable medical devices intended by manufacturers for single use is controversial, and there is little available research on the subject. Three issues must be considered when making a decision regarding reprocessing a disposable medical device: the device’s function and safety after reprocessing; the legal and ethical issues associated with the device; and economic concerns.
Each single-use medical device should be considered on an individual basis after carefully validating the safety and efficacy of the item after reprocessing. A single-use medical device that cannot be cleaned, sterilized, or disinfected without damage to its integrity and/or function should not be reprocessed.
Patient safety should be the primary concern when considering reprocessing single-use medical devices. Reprocessing is not recommended unless manufacturers provide written instructions for resterilizing the single-use devices, or unless the health care facility can demonstrate and document that the patient’s safety and the medical device’s effectiveness and integrity are not compromised.
Validation of the safety, efficacy, and integrity of a reprocessed device should be based on an established reuse-testing protocol. The objective of this protocol is to determine if a disposable medical device can be safely reprocessed and reused. This protocol should apply to medical devices that 1) have been used, 2) are unused but have exceeded their expiration dates or have been inadvertently contaminated, and 3) have been opened and removed from their sterile packaging but not used.
Reuse-testing protocol. The reuse-testing protocol should include the following steps:
• Check package labels and inserts for manufacturer guidelines for reprocessing and reuse.
• If there are no manufacturer’s guidelines, contact the manufacturer for information on the physical properties of the medical device and, if possible, obtain information on cleaning, packaging, and resterilizing the medical device.
• Establish form and function criteria that the reprocessed medical device will be expected to meet, such as physical characteristics, (color, shape, and size) and function (motion, flexibility, and tensile strength).
• Determine the cost-effectiveness of reprocessing: cost of device; expected volume of use; labor, overhead, and materials cost of reprocessing; and risks and consequences of medical device failure.
Individual consideration. Each device should be given individual consideration, including:
• necessary sample size for an adequate study;
• number of times the device can be reprocessed and still meet form and function criteria;
• procedures, chemicals, and equipment used for cleaning and sterilizing;
• processing controls, quality assurance monitoring, and documentation of controls and monitoring activities;
• testing in simulated-use situations;
• necessity for destructive testing to identify unacceptable changes in the device or any residual toxicity;
• documentation of all testing results;
• and method of labeling and tracking of successive processing.
Test protocols and results should be reviewed periodically with the facility’s administrators, legal counsel, infection control committee, and medical device manufacturers. Policies on patient charges, informed surgical consents, documentation, safety, and cost-effectiveness also should be reviewed on a periodic basis.
Decisions. The decision to reprocess disposable (i.e. single-use) devices should not be taken lightly. In some instances, it can be extremely difficult, if not impossible, to document that a device can be reprocessed without residual toxicity and still function safely and effectively.
If single-use medical devices are reprocessed, the procedure should be consistent through- out the facility, and all reprocessing should conform to the facility’s established policies and protocols.
[Editor’s note: This article was reprinted with permission from AORN Online (http://www.aorn.org/), 1997. AORN Inc., 2170 S. Parker Road, Suite 300, Denver, CO 80231.]
Selected references
American Society for Hospital Central Service Personnel, International Association of Healthcare Central Service Material Management. Position Paper No. 1: Reprocessing Medical Devices. Chicago: International Association of Healthcare Central Service Material Management; 1994.
Greene VW. Reuse of disposable medical devices: historical and current aspects. Infection Control 1986; 7:508-513.
American Hospital Association. Technical Advisory Bulletin: Reuse of Disposable Medical Devices. Chicago: American Hospital Association; 1986, 1-2.
Reichert M. Reuse of single-use devices: a program model. Infection Control 1993; 28:697-709.
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