Reprocessing single-use devices—regulatory roles

AORN Journal,  July, 2002  by Debra Dunn

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Reliable reprocessor requirements. In general, third-party reprocessors have not always provided complete documentation of their processes to the government as required. Commercial firms reprocessing SUDs should meet or exceed applicable FDA, AAMI, CDC, OSHA, AORN, and AHA standards. They must register with the FDA as medical device manufacturers and meet GMPs. (67) A background check of the reprocessor facility should be performed through the Freedom of Information Act (FOI) by contacting the FOI office in Rockville, Md. Additionally, determine if the reprocessor has been inspected by the FDA. If so, ask if the reprocessor ever received a letter of warning and what the action plan was to correct problems found during the inspection. These documents help the hospital assess "good intent" on the reprocessor's part and the working relationship it has with the FDA. Also ask to see paperwork demonstrating self-directed, internal audits; problem areas noted; and corrective actions taken.

Third-party reprocessors should belong to the AMDR, a Washington DC-based trade organization representing third-party reprocessors of medical devices labeled for single use. The AMDR provides a forum for reprocessors to solve problems and to develop foundation principles. This organization sets quality standards for reprocessors, such as requiring that third-party reprocessors

* have adequate liability insurance coverage (ie, minimum $5 million),

* use biological indicators for routine sterilization,

* are in compliance with QSR,

* comply with MDR requirements,

* are functionally testing products on a routine basis,

* are registered with the FDA,

* have reprocessing procedures that are tailored and validated for each device,

* routinely test residual sterilant levels,

* allow site visitation with review of their quality manual,

* requalify sterilization cycles annually, and

* use a sterilization system that is certified and commissioned in accordance with ANSI/AAMI/ISO ST11135 S1 1994. (68)

Reprocessors should follow professional organization standards, such as American National Standards Institute (ANSI), AAMI, or International Organization for Standardization (ISO) standards when reprocessing instruments. For example, ethylene oxide (EO) residuals and biocompatibility testing, which includes hemolysis, cytotoxicity, sensitization testing, and pyrogen testing, should be determined with sterilization. The AAMI standards provide accepted industry practices and guidelines. (69) Another question to ask the reprocessing company is whether products from different hospitals and health care facilities are intermingled. Ideally, the hospital should receive the exact same items back that it sends in, minus rejected items. Items that are rejected for reprocessing by the third-party reprocessor are included in a report for the health care facility. (70) Finally, ask the reprocessor for a hospital user list. Contact these hospitals to see how the program is working for them. When the decision has been made to outsource to a reprocessor, hospital administrators are responsible for selecting the company.