Q Can we re-use single-use devices (SUDs) that were opened in the OR but not used?

A When the staff opens too many SUDs for a case, and some remain on the back table, you have two choices: Throw them away or reprocess them.

Before you reprocess, get written instructions from the manufacturer on how to safely clean, wrap and re-sterilize the device and follow those instructions to the letter. If the manufacturer is not forthcoming with this information - and many SUD manufacturers will not be - develop a process for handling each device and validate that your process results in a product that is safe and effective. If this is not possible, then you must go to a third-party reprocessor.

Q What if we brought the SUDs to the OR but never opened them?

A When a device in the OR remains in its sterile package, most of the time, you may simply return it to the clean storage area. The only exception is if the sterile integrity of the package has been compromised during storage or transit. Carefully inspect and, if needed, clean any sterile package that has been soiled before returning it to the storage area.

Q What about reprocessing SUDs that have been used?

A Whether you should reprocess SUDs that have come into contact with the patient's tissue or body fluids is an increasingly complex issue. There are probably very few dangers associated with cleaning, sterilizing and reusing such simple SUDs as retractors, surgical curettes, ophthalmic knives, saw blades, keratome blades, laparoscopic dissectors, medical disposal scissors and non-electric biopsy forceps. While these are easy to clean and can accommodate the temperature and pressures of steam sterilization, the same can't be said about rubber, plastic or lumened devices, including electric biopsy forceps, laparoscopes and blood pressure cuffs.

See writeOutLink("www.FDA.gov/CDRH/reuse",1) for a list of commonly reprocessed SUDs and the degree of risk the FDA believes each device poses when reprocessed. The FDA has put reused SUDS into three categories of risk - high, medium and low. Do not, under any circumstances, consider high- (Class III) or medium-classed (Class II) items as possibilities for your in-house processing. Access classifications at www.accessdata.fda.gov/ scripts/cdrh/cfdocs/cfpcd/classification.cfm.

Q What does it mean if a third-party reprocessor is registered with the FDA, is a member of the Association of Medical Device Reprocessors (AMDR) is ISO (International Organization for Standardization) 9001 and ISO 13485 certified?

A The FDA regulates hospitals that reprocess SUDs the same way it regulates device manufacturers. The regulations, which do not apply to other healthcare facilities or to opened-but-unused SUDs, can be accessed at writeOutLink("www.fda.gov/cdrh/comp/guidance/1168.pdf",1).

The AMDR has rigid guidelines for members, including quality-assurance and training programs, finished-product testing procedures and liability insurance. While it is true that there may be a company that meets the criteria for producing safe and effective reprocessed SUDs that is not a member of AMDR, membership carries guarantees of compliance with industry standards. The FDA also regulates these companies to assure compliance with good manufacturing practices mandated by provisions of the Medical Device Amendments to the Food, Drug, and Cosmetic Act.

When a company is ISO 9001 and/or ISO 13485 certified, the company has been assessed by an ISO team that reviews the steps taken, tests done and records kept to prove the products are safe for patient use. In the case of reprocessing, you may be assured that any item cleaned, packaged and sterilized is safe for patient use.

Q How should I handle informed consent?

A If you use a third-party reprocessor, getting a patient's informed consent is not necessary, because reprocessed SUDs then qualify as FDA-approved medical devices. You might want to add to your admissions boilerplate a sentence that states your position regarding reuse of SUDs, including any that you might do in-house.