When You are the Manufacturer: Facts to Consider

Single-use device (SUD): A device intended by the manufacturer to be used on one patient during one procedure. The device is not intended for reprocessing and/or use on another patient or on the samepatient at another time. Device labeling may or may not identify the device as single-use or disposable,but manufacturer instructions for reprocessing are absent.

Reprocessing Single Use Devices
The reprocessing of single-use devices (SUD) by health care facilities is regulated by FDA, and all pre-market and post-market requirements must be met if a health care facility chooses to reprocess a single-use device. Health care facilities are encouraged to keep themselves informed on FDA regulations because changes might occur (see http://www.fda.gov/cdrh/reprocessing/). (AAMI ST79 Section 5.3)2

Manufacturers’ Instructions
The written instructions of the device manufacturer should always be followed… Sterilization qualification of a device requires microbiological, engineering, toxicological, and sometimes clinical evaluations of the device, which are well beyond the abilities of most health care facilities. The device labeling should identify specific methods of cleaning and sterilization that have been validated by the manufacturer. The manufacturer’s written instructions should be kept on file and periodically reviewed for any updates. If there are no specific instructions in the labeling, then the manufacturer should be contacted directly to provide a documented method. See also Annex D, AAMI TIR12, and FDA (1996a). (AAMI ST79 Section 7.2.2)2

The manufacturer’s written instructions for use (IFU) are the basis for the department’s policies and procedures and must be kept up-to-date.

FDA on SUDs
Third Party Reprocessor, as well as hospitals that reprocess SUDs must meet all applicable pre-market requirements listed in the reuse SUD guidance document (pre-market notification and approvals, medical device tracking etc.
Q: Should my hospital comply with the Quality System Regulation even if the SUDs that we are reprocessing do not require pre-market submissions to the FDA?
A: Yes. Regardless of whether or not the SUDs that your hospital is reprocessing require pre-market submissions, your hospital is required to meet the requirements of the Quality System Regulation [which also is referred to as the current Good Manufacturing Practice (cGMP)] as described in 21 CFR Part 820.

Q: What are FDA’s requirements for reporting an adverse event with a SUD reprocessed by the hospital?
A: If a hospital reprocesses a device that was previously marketed as a single-use device, FDA considers the hospital to be the manufacturer of that device and subject to the same adverse event reporting requirements (Medical Device Reporting or “MDR”) as original equipment manufacturers or commercial reprocessors. A manufacturer is defined in Title 21 of the Code of Federal Regulations (CFR) at 803.3(o) as “any person who manufactures, prepares, propagates compounds, assembles, or processes a device by chemical, physical, biological, or other procedure.” The manufacturer MDR requirements are in addition to the hospital’s current user facility adverse event reporting requirements.

If you reprocess without having validated, Food and Drug Administration-cleared IFUs from the device you can’t assume the items are safe for patient use. That’s because the facility has not validated the change and submitted the data to the FDA in a 510(k) submission. Though your facility may have performed product testing to verify the changes, that is not the same as validation testing by the medical device manufacturer. It’s important to understand the difference.4

Validation: “Documented procedure for obtaining, recording, and interpreting the results required to establish that a process will consistently yield product complying with predeterminedspecifications” (AAMI ST79 Section 2.129). Validation covers 3 activities: installation qualification,operational qualification, and performance qualification. AAMI also says that validation is performed by the device manufacturer.4

User verification: “Documented procedures, performed in the user environment, for obtaining,recording, and interpreting the results required to establish that predetermined specifications have been met” (AAMI ST79 Section 2.128).2

User verification is product testing to determine if a health care facility can sterilize a medical device based on the predetermined specifications (eg, packaging, cycle parameters) that the medical device manufacturer provides as a result of its validation testing.4

Can your facility perform validation testing?
“If you are considering performing validation testing, answer these questions. If any of the answers areno, don’t attempt to perform validation testing. Does your facility have:
• the personnel has the expertise or the ability to change the sterilization equipment cycles to perform half cycles, fractional cycles, or incremental critical process parameter cycles using spore strips, inoculated threads, or liquid spore suspensions?
• a laboratory capable of aseptically retrieving the BI samples, placing them in the appropriate media, and incubating them at the correct temperature?
• expertise or multiple calibration temperature sensors to do internal temperature mapping inside the containers or other packaging?
• expertise and required equipment to perform sterility maintenance testing and microbial challenge testing?
• resources to maintain contact with the original device manufacturers to ensure you know when design changes are made on devices so you can determine if you need to repeat validation testing?”4

The Joint Commission – National Patient Safety Goals (NPSG)

NPSG.07.05.01 “Implement evidence-based practices for preventing surgical site infections.”
Element of performance #3
“Implements policies and practices aimed at reducing the risk of surgical site infections. These policies and practices meet regulatory requirements and are aligned with evidence-based guidelines (for example, the Centers for Disease Control and Prevention [CDC] and/or professional organization guidelines).”

References
1 Association of periOperative Registered Nurses. AORN Guidance Statement: Reuse of Single Use Devices in: Perioperative Standards and Recommended Practices 2011, AORN Denver, p650
2 Associations for the Advancements of Medical Instrumentation. Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Faculties. ANSI/AAMI ST79:2010 Arlington, VA, AAMI, 2010 www.aami.org
3 FDA Medical Devices Frequently Asked Questions, at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ReprocessingofSingle-UseDevices/ucm121093.htm, accessed on March 29, 2011.

www.SeaveyHealthcareConsulting.com. 3/29/2011

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Rose Seavey MBA, BS, RN, CNOR, CRCST, CSPDT
President/CEO Seavey Healthcare Consulting, LLC

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