Reprocessed Single-Use Devices: Frequently Asked Questions

The practice of reprocessing devices that are intended or labeled for single-use (known as single-use devices, SUDs) began in hospitals in the late 1970s. Since that time, the practice has become widespread as a mechanism to save costs for health care facilities and reduce medical waste. For example, use of reprocessed SUDs may reduce environmental impact by limiting the use of non-renewable resources and decreasing the amount of medical waste that requires treatment and disposal. The FDA has worked to ensure the safety and effectiveness of reprocessed SUDs by regulating device manufacturers, third party reprocessors, and hospitals that reprocess SUDs in the same manner as the original equipment manufacturer (OEM). In doing so, reprocessors of SUDs are held to the same regulatory requirements as the original manufacturer of the single use device.

This page provides answers to frequently asked questions about reprocessing single-use devices.

On this Page:

• What are “reprocessed single-use devices (SUDs)”?
• What does the FDA require to demonstrate the safety and effectiveness of reprocessed SUDs?
• Can any SUD be reprocessed?
• Is there a maximum number of times that a SUD may be reprocessed?
• How do we know if a SUD has been reprocessed?
• What degree of oversight does the FDA have on reprocessed SUDs?
• What are “Critical,” “Semicritical,” and “Noncritical” reprocessed SUDs?
• Which reprocessed SUDs require premarket review by the FDA?

1. What are “Reprocessed Single-Use Devices (SUDs)”?

Section 201(ll) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) includes the following relevant definitions.

• Single-use device: The term ‘single-use device’ means a device that is intended for one use, or on a single patient during a single procedure.
• Reprocessed: The term ‘reprocessed’, with respect to a single-use device, means an original device that has previously been used on a patient and has been subjected to additional processing and manufacturing for the purpose of an additional single use on a patient. The subsequent processing and manufacture of a reprocessed single-use device shall result in a device that is reprocessed within the meaning of this definition.

2. What does the FDA require to demonstrate the safety and effectiveness of reprocessed SUDs?

The requirements applicable to reprocessed SUDs are in sections 502(v), 510(o) and 515(c)(2) of the FD&C Act, these requirements include (among others):

• Labeling identifying the devices as reprocessed,
• Submission of premarket notifications (510(k)s) with validation data for certain SUDs, including some that were previously exempt from 510(k) submission requirements, and
• Submission of premarket reports (PMR) to support the premarket approval of all proposed Class III reprocessed SUDs

In addition, the FDA has issued several guidance documents (see Additional Resources below) with recommendations on the applicability of statutory and regulatory requirements for reprocessed SUDs.

3. Can any SUD be reprocessed?

Some SUDs may not be suitable for reprocessing. Reprocessed SUDs should be capable of withstanding necessary cleaning, disinfection or sterilization, and continue to comply with all applicable FDA requirements after each instance of reprocessing, up to the maximum number of times that the devices are intended by the reprocessors to be reprocessed. Therefore, the FDA expects that reprocessors of SUDs demonstrate:

• the device can be adequately cleaned and disinfected or sterilized,
• the physical characteristics or quality of the device will not be adversely affected by these processes, and
• the device continues to comply with applicable FDA requirements.

4. Is there a maximum number of times that a SUD may be reprocessed?

Yes. As required by the FD&C Act, 510(k)s for certain reprocessed SUDs must include validation data, including functional performance data, that demonstrates that the SUD remains as safe and effective as (substantially equivalent to) the predicate device after the maximum number of times the device is intended to be reprocessed as identified by the reprocessor. Such data is also required in premarket reports for a Class III device that is a reprocessed single-use device.

5. How do we know if a SUD has been reprocessed?

In accordance with section 502(v) of the FD&C Act, reprocessed SUDs must be labeled with the statement ‘‘Reprocessed device for single use. Reprocessed by [the person or establishment responsible for reprocessing]’’ in addition to generally applicable device labeling requirements.

6. What degree of oversight does the FDA have on reprocessed SUDs?

Third party reprocessors, including health care facilities that reprocess SUDs, are considered by the FDA to be manufacturers and as such must comply with all applicable statutory and regulatory requirements, including among others:

• Quality System Regulation (section 520(f) of the Act; 21 CFR Part 820)
• Medical Device Reporting (section 519(a)-(c) of the Act; 21 CFR Part 803)
• Registration and Listing (section 510 of the Act; 21 CFR Part 807)
• Labeling (section 502 of the Act; 21 CFR Part 801)
• Premarket Approval and Premarket Notification (510(k) (sections 510, 513 and 515 of the Act; 21 CFR Part 814 and 21 CFR Part 807)

7. What are “Critical,” “Semicritical,” and “Noncritical” reprocessed SUDs?

These terms are defined in section 201(mm) of the FD&C Act and in the Federal Register (September 29, 2005, 70 FR 56911), as follows

• Critical reprocessed single-use device: a reprocessed SUD that is intended to contact normally sterile tissue or body spaces during use.
• Semicritical reprocessed single-use device: a reprocessed SUD that is intended to contact intact mucous membranes and not penetrate normally sterile areas of the body.
• Noncritical reprocessed single-use device: a reprocessed SUD that is intended to make topical contact and not penetrate intact skin.

8. Which reprocessed SUDs require premarket review by the FDA?

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. However, for certain Class I or II SUDs that were originally exempt from premarket review, the reprocessing steps may alter the safety and/or effectiveness profile of the device and require FDA’s review of reprocessing validation data as part of premarket submissions. As required by section 510(o)(2) of the FD&C Act, the FDA evaluated the critical and semicritical reprocessed SUDs that were previously exempt from premarket notification requirements and determined device types for which such exemptions should be terminated (thus requiring premarket review (see 70 FR 56911).

Additional Resources

• Reprocessing Single Use Medical Devices: Information for Health Care Facilities | FDA
• Overview of Device Regulation | FDA
• Recalls, Corrections and Removals (Devices) | FDA
• Medical Device User Fee and Modernization Act of 2002 (MDUFMA), P.L. 107-250 | FDA
• Medical Devices; Reprocessed Single-Use Devices; Termination of Exemptions from Premarket Notification; Requirement for Submission of Validation Data (September 29, 2005, 70 FR 56911)
• CPG Sec. 300.500 Reprocessing of Single Use Devices 2005 |FDA
• Frequently-Asked-Questions about the Reprocessing and Reuse of Single-Use Devices by Third-Party and Hospital Reprocessors - Three Additional Questions: Guidance for Industry, FDA Staff, Third-Party and Hospital Reprocessors 2003 | FDA
• Frequently-Asked-Questions about the Reprocessing and Reuse of Single-Use Devices by Third-Party and Hospital Reprocessors: Final Guidance for Industry and FDA Staff 2001 | FDA
• Labeling Recommendations for Single-Use Devices Reprocessed by Third Parties and Hospitals; Final Guidance for Industry and FDA | FDA
• Single-Use Devices | Disinfection & Sterilization Guidelines | Guidelines Library | Infection Control | CDC
• Guidance for Industry and FDA Staff - Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices | FDA
• Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling - Guidance for Industry and Food and Drug Administration Staff | FDA

Content current as of:

Regulated Product(s)

• Medical Devices