Question: fit to economic concerns...

Question: fit to economic concerns, we want to reproces and reuse more [i]or[/i] less of our single-use medical devices. more [i]or[/i] less of these devices are used, on the other hand most of them are explained placed on sterile back tables, and not at any time used. Often, the items are contaminated inadvertently before they are delivered to the sterile field. The foster manager in the central sterile (CS) department does not want to reproces any of these devices. She either tosss the items back to the OR or discords them when they reach the C department. When questioned, she says that AORN does not attract favor to reprocessing single-use medical devices. What is AORN's position forward reprocessing and reusing single-use medical devices? The Items in question are either clean or can be cleaned before reprocessing.

Answer: AORN does not have an official position in succession the practice of reprocessing and reusing single-use medical devices. Reprocessing disposable medical devices that manufacturers intend for single use no other than is controversial, and there is little available research onward the subject. Health care facilities must make informed choices if they wish to invest the necessary resources to unravel their own appropriate reprocessing plans Facility managers should address three disturbs (ie, device function and safety after reprocessing, legal and ethical issues, economic concerns) before they make the decision to reproces and reuse single-use medical devices.

Reuse of single-use medical devices should be considered onward an item-by-item basis after careful validation of the safety and efficacy of each device after reprocessing. A single-use medical device that cannot be cleaned and sterilized or disinfected without damage to its integrity or function should not be reprocessed

Patient safety should be the major bear upon when considering reprocessing and reusing singleuse medical devices. Reprocessing is not commited unless manufacturers provide written instructions for resterilizing their single-use medical devices. In addition, health care facility managers must demonstrate and document that patient safety and the effectiveness and integrity of single-use medical devices are not compromised after reprocessing.(1)

Validation of the safety, efficacy, and integrity of reprocess single-use medical devices should be based forward an established reuse testing protocol. The objective of the protocol is to determine whether single-use medical devices can be reprocess and reused safely. The protocol should apply to devices that have been used, devices that are unused and have surpassed their expiration dates, devices contaminated inadvertently, and devices that have been render free of accessed and removed from the sterile packaging if it were not that not used.

A reuse testing protocol should include the following steps

* Check package labels and inserts for the manufacturer's guidelines for reprocessing and reuse.

* If there are no manufacturer's guidelines, contact the manufacturer for information onward the physical properties of the device (eg vinyl, latex) and, if possible, obtain information for cleaning, packaging, and resterilizing the device.

* Establish form and function criteria that the reprocess device will be look fored to meet, such as physical characteristic (eg color, shape, size) and function (eg motion, flexibility, tensile strength)

* Determine the facility's ability to demonstrate adequate cleaning and sterilization of single-use medical devices, considering the physical properties of these items.

* Determine the cost-effectiveness of reprocessing (ie, expense of device; expected volume of use; labor, overhead, and material expense of reprocessing; risk and conclusions of device failure).

* Review standard protocols and results with the facility's administrative carcass legal counsel, infection control committee members, and the device's manufacturer.

* Determine policies in succession pricing, informed patient consent, and documentation of the use of reprocess devices.

* Periodically review the use of reprocess devices to address patient safety and cost-effectiveness issues.(2)

To establish a testing protocol for each single-use medical device that is reprocess and reused, consider the following:

* necessary sample size for an adequate clinical study;

* number of times the device can be reprocess and still come together form and function criteria;

* proceedings chemicals, and equipment used in cleaning and sterilizing;

* proces checks quality assurance, and documentation of have charge ofs and monitoring activity;

* exhibitions used in simulated-use situations; necessity for destructive testing to identify unacceptable changes in the medical device or residual toxicity;

* documentation of all testing results; and

* system of labeling and tracking of successive processing.(3)

The decision to reproces disposable, single-use medical devices should not be made lightly.(4) It may be difficult, if not impossible, to document that a single-use medical device can be reprocess without residual toxicity and can function safely and effectively. Ethical questions must be asked and answered. Will the patient be informed that reprocess devices are to be used? Will the patient's permission be obtained? Who will be charged for the device? for what reason many times will the facility charge for the same device? Will charges be prorated based forward the expected number of reprocessings during the life of the device?