Risk categorization scheme draft published

The Food and Drug Administration (FDA) has published draft guidance on its risk categorization scheme for reprocessing and reuse of single-use devices. The document directs health care providers on how to determine the risk posed by single-use devices that are reprocessed and/or reused. (For information on the FDA’s proposed revisions to its policy on reprocessing of single-use devices, see Same-Day Surgery, January 2000, p. 1.)

The risk categorization scheme (RCS) labels the risk category as low, moderate, or high, and follows these steps:

• Look at the inherent risk as reflected in the device’s generic classification. One factor is whether the device is classified as Class I, II, or III under the medical device provisions of the Food, Drug, and Cosmetic Act. (See work sheet enclosed in this issue.)

• Determine the risk of infection posed by reprocessing and reusing the device. (See Flowchart 1, enclosed in this issue.) Label the risk of infection as critical, semicritical, or noncritical depending on the invasiveness of the device in a method described by E.H. Spaulding in his 1972 article.1

• Determine the risk of inadequate performance of a reprocessed and/or reused device. (See Flowchart 2 enclosed in this issue.)

If the grade for either risk of infection or risk of inadequate performance is 2, the devices is categorized as high risk. If the score for risk of infection is less than 2 and the score for risk of inadequate performance is less than 2, the scores for all three parameters are totaled. If the total score is 3 or 4, the device is categorized as moderate risk. If the total is less than 3, the device is categorized as low risk.

For clarification, the FDA offers this example:

An anesthesia breathing circuit device consists of flexible or rigid tubing that is used to convey gases to the patient. It is indirect-patient contacting and is usually constructed of polyvinyl chloride (PVC). It might be labeled for single use or reuse, but the wall thickness of the single use device is usually thinner than the reusable device. The device is often reprocessed by hot water infection. This device is a class I device according to the FDA medical devices classification process.

Flowchart 1: All of the answers to the questions in Flowchart I are no. Therefore, the numerical value associated with infection risk for this device is 0.

Flowchart 2: The breathing circuit does not contain materials, coatings, or components that might be damaged or altered by a single use in such a way that the performance of the device might be affected. Therefore, the numerical value associated with that criteria is 0. The other factors included in Flowchart 2 do not need to be considered in this case.

The total score for the anesthesia breathing circuit is 0. Therefore, this device may be considered low risk.

Reference

1. Spaulding EH. Chemical disinfection and antisepsis in the hospital. J Hosp Res 1972; 9:5-31.

For copies of Guidance for Industry and Reviewers: Reprocessing and Reuse of Single-Use Devices Risk Categorization Scheme (Draft), go to the FDA’s Center for Devices and Radiological Health (CDRH) Web page: www.fda.gov/CDRH/reuse, or contact CDRH Facts on Demand at (800) 899-0381 or (301) 827-0111. Specify number 1156 when prompted for the document shelf number.