Meeting AAAHC Standards for Reprocessing Single-Use Devices and Equipment

Jack Egnatinsky, MD, medical director of the AAAHC and a retired anesthesiologist, discusses what ASCs must do to meet AAAHC standards if they reprocess single-use devices and equipment.

Dr. Jack Egnatinsky: With many ASCs looking to save money, more and more are reprocessing single-use devices and equipment. Although the most common items sent for reprocessing are arthroscopic shavers and laparoscopic probes and forceps, many organizations are reprocessing other devices and equipment such as saw blades, drill bits, endoscopic scissors and others.

AAAHC Standards 7-I,M (Infection Control) and 10-I,P (Surgical Services) state, "Reprecessing of single-use devices must comply with FDA guidelines, and the devices must have been cleared under the FDA 510(k) process. Policies must clearly dictate the cleaning and handling of these devices in-house before sending them out for reprocessing. A written log must be maintained on all reprocessed devices." The FDA website can be overwhelming, but the best website to search for products you are considering for reprocessing is here.

If you decide to reprocess in-house or through an affiliated hospital, you still must meet all requirements of the AAAHC standard and the FDA standards. If you send your products out to an FDA-recognized reprocessing company, you should clearly understand if you will be getting your own devices back after reprocessing. You should ask them how many times a device can be reprocessed and how they track this. If after cleaning and inspection they determine that a device can not be properly reprocessed, do they discard it or return it to you to discard? The latter process assures you that they have not diverted your equipment and/or devices to another customer.

Reprocessing of single use equipment can be cost efficient, but if not done correctly can lead to much greater costs in the long run for your patients and increase your liability.