You Want to Reprocess Single-Use Instruments?

Hospital and Ambulatory Surgery Centers (ASCs) face unprecedented pressure to control institutional costs to lower overhead and maximize profits.  In an effort to achieve cost containment, many facilities place themselves in risk of compromising patient care, increasing potential for surgical site infections and complications, as well as violating regulations for sterilization, validation, and lot traceability. While reprocessing may seem like a good financial strategy, many hospitals & ASCs may not realize that when a Single-Use Device (SUD), such as a sterile instrument or implant is reprocessed, the reprocessor is required to follow the same FDA requirements as a medical device manufacturer. The responsibilities, and liabilities, previously managed by the Original Equipment Manufacturer (OEM) become the responsibility of those care facilities. 

What makes these regulations so important? Assurance of quality and safety for patients are fundamental responsibilities of medical device manufacturers and healthcare providers to ensure accountability for safe and effective products used in surgical procedures. Cost cutting to increase profitability must never take precedent over patient care, yet many do take these avoidable risks. One should weigh the financial benefits of reprocessing SUDs versus the cost of potential harm to patients, facility expense for infections, and/or adverse events. This represents not only a risk of liability, but also reputational damage.

What is a Single Use Device (SUD)?

According to the FDA, a Single-Use Device is “a device that is intended for one use, or on a single patient during a single procedure.”[1] These devices are labeled as such by OEMs who make significant investment in product development, manufacturing processes, and creation of a Quality Management Systems (QMS) to validate safety, efficacy, and sterility of products. These regulations are in accordance with FDA guidelines for a “Single-Use Device” to ensure safety. OEMs pay the FDA approximately $10,000 per year to legally process SUDs and assume liability for the sterility and function of these devices for their intended Single-Use. After the device has been used, they are intended to be disposed of, not reprocessed, as they are no longer validated as safe for re-use. Reprocessing requires verification & validation that the SUDs will still operate as intended and have been re-sterilized, however no re-sterilization parameters exist to outline safe and effective reprocessing and they need to be developed in compliance with FDA guidelines. If a third party facility takes it upon themselves to reprocess SUDs they "are considered by the FDA to be manufacturers and as such must comply with all applicable statutory and regulatory requirements.”[2] The process for these regulatory requirements are described by the FDA. 

What are the FDA Guidelines?

           While a pathway exists for Hospitals and ASCs to reprocess SUDs, requirements to ensure patient safety must be completed in accordance with existing FDA guidelines. Some of these FDA guidelines are:

1.      Registration: “Owners or operators of establishments (including healthcare facilities per 510(O) 807.20) that are involved in the production and distribution of medical devices intended for use in the U.S. are required to register annually with the FDA.”[3] This includes an annual registration fee.

a.      Fee - FY 2025 (October 1, 2024-September 30, 2025) - $9,280

b.      FDA Classifications: Who Must Register, List and Pay the Fee

2.      Quality Management Systems: In order to reuse Single-Use instruments and devices, facilities are required to perform the same regulations as OEMs, including manufacturing and processing according to the manufacturers specifications, sterilization procedure, gathering all necessary validation data, and documenting a quality management system to continue and ensure quality. “Manufacturers (and Healthcare institutions reprocessing SUDs) must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications.”[4] According to the FDA, “it is the responsibility of each manufacturer to establish requirements for each type or family of devices that will result in devices that are safe and effective, and to establish methods and procedures to design, produce, distribute, etc. devices that meet the quality system requirements.”[5]

a.      Once the classification is determined and the pre-market notification requirements are met, the validations must be supported by an ongoing quality management system. “Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications.”[6]

b.      International Organization for Standardization (ISO), ISO 13485:2016 has been incorporated into the FDA guidance for quality management systems starting in early 2026.[7]

3.      Classification: The FDA categorizes medical devices into one of three classes based on the level of risk.[8] OEMs determine the classification for each SUD they manufacture. If a facility reprocesses an SUD, they must adhere to the same classification as determined by the OEM. This must be done on every new reprocessed SUD. Class I & II SUDs may require a pre-market notification to the FDA which outlines their testing and validation data, and which must define a specific maximum number of times the device can be reprocessed safely and efficaciously in each of the following areas:^[9]

a.      Cleaning

b.      Disinfecting

c.      Sterilization (if required)

d.      Functional performance 

4.      Unique Device Identification: A device’s quality management system is connected to the device itself via a Unique Device Identification (UDI), which must be registered with the FDA’s Global Unique Device Identification Database (GUDID). “When fully implemented, the label of most devices will include a unique device identifier (UDI) in human- and machine-readable form, which will ultimately improve patient safety, modernize device postmarket surveillance, and facilitate medical device innovation.”[10]

5.      Labeling & Reporting: “Reprocessed SUDs must be labeled with the statement 'Reprocessed device for single use. Reprocessed by [the person or establishment responsible for reprocessing].' Reprocessed SUDs that lack this required labeling information are considered misbranded. Third party reprocessors and health care facilities that reprocess SUDs must also meet applicable device labeling requirements (21 CFR Part 801), including unique device identification (21 CFR Part 830).”[11]

a.      See: Labeling Recommendations for Single-Use Devices Reprocessed by Third Parties and Hospitals: Final Guidance for Industry and FDA

6.      Premarket Notification & Validation: “Not all reprocessed SUDs require the FDA’s review of premarket submissions. SUDs that originally required premarket review would continue to require premarket oversight to evaluate the reprocessing validation information of a reprocessed SUD. This includes 510(k) submissions (for certain Class I or II reprocessed SUDs) and Premarket Reports (for Class III reprocessed SUDs), as discussed in sections 510 and 515 of the FD&C Act, respectively.”[12]

So, what are the Costs of Compliance?

           Reprocessing SUDs may be a viable strategy for your institution to control costs and reduce medical waste, however doing so is not as simple as washing a disposable and then running it through an autoclave. The practicality of reprocessing SUDs must be measured against the cost of doing so in a legally mandated and FDA compliant manner that is safe and efficacious. The viability of this is dependent on the needs of each institution and is ultimately a business decision that each Hospital and ASC should consider carefully. Costs can vary drastically depending on the class of SUD your facility would like to reprocess, whether or not it requires a 510K premarket notification or a premarket approval, as well as the depth and complexity of the ongoing quality control system you are required to maintain. A rough estimate for Class I or II SUDs which require a 510K premarket approval are as follows:

Reprocessing Single-Use Devices (SUDs) may appear to be a practical solution for healthcare facilities striving to reduce costs and environmental impact, but it is a path that comes with significant regulatory, legal, and financial obligations. Hospitals and ASCs that choose to reprocess must fully assume the responsibilities of a medical device manufacturer—including strict adherence to FDA guidelines on registration, validation, labeling, and ongoing quality management systems. While the cost savings of reprocessing may seem appealing, the true cost lies in ensuring patient safety, maintaining compliance, and mitigating potential liability. Ultimately, each institution must weigh the potential benefits against the regulatory complexities and long-term risks to determine if reprocessing is the right decision for their patients and facility.

Works Cited

Center for Devices and Radiological Health. “515 Program Initiative.” U.S. Food and Drug Administration, FDA, www.fda.gov/about-fda/cdrh-transparency/515-program-initiative. Accessed 14 May 2025.

Center for Devices and Radiological Health. “Device Registration and Listing.” U.S. Food and Drug Administration, FDA, www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing. Accessed 14 May 2025.

Center for Devices and Radiological Health. “QS Regulation/Medical Device Current Good Manufacturing Practices.” U.S. Food and Drug Administration, FDA, www.fda.gov/medical-devices/postmarket-requirements-devices/quality-system-qs-regulationmedical-device-current-good-manufacturing-practices-cgmp. Accessed 14 May 2025.

Center for Devices and Radiological Health. “Reprocessed Single-Use Devices: Frequently Asked Questions.” U.S. Food and Drug Administration, FDA, www.fda.gov/medical-devices/reprocessing-single-use-medical-devices-information-health-care-facilities/reprocessed-single-use-devices-frequently-asked-questions#Q1. Accessed 14 May 2025.

Center for Devices and Radiological Health. “Reprocessed Single-Use Devices: Frequently Asked Questions.” U.S. Food and Drug Administration, FDA, www.fda.gov/medical-devices/reprocessing-single-use-medical-devices-information-health-care-facilities/reprocessed-single-use-devices-frequently-asked-questions#Q8. Accessed 14 May 2025.

Center for Devices and Radiological Health. “Reprocessing Suds: Information for Health Care Facilities.” U.S. Food and Drug Administration, FDA, www.fda.gov/medical-devices/products-and-medical-procedures/reprocessing-single-use-medical-devices-information-health-care-facilities. Accessed 14 May 2025.

Center for Devices and Radiological Health. “Unique Device Identification System (UDI System).” U.S. Food and Drug Administration, FDA, www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Accessed 14 May 2025.