Overview
The United States Food and Drug Administration (FDA) is responsible for establishing, maintaining, and enforcing laws concerning the manufacture, marketing, and sale of Class II medical devices, including steam sterilizers. Health Canada is similarly responsible for like activities in Canada.
Definitions
First, FDA definitions are needed as the law treats each activity differently.
What does it say about refurbished units?
The ownership of the device changes – The owner sells the device to another party and the new owner performs work on the device. Service or repairs are performed to maintain or return to the original operating specifications.
What does it say about remanufactured units?
The ownership of the device is irrelevant. To meet new operating specifications, work is performed on the device. The device is remanufactured to new specifications.
What does it say about service and repair?
The ownership of the device does not change. The owner either makes a contract with another party to perform work on the device or performs the work themselves.
What does it say about service?
The device is working and regular maintenance is performed to maintain the original operating specifications.
What does it say about repair?
The device is malfunctioning so repairs are performed to return to the original operating specifications.
Recertify
A device that has undergone one of the activities above is then tested to verify that it meets the current (either the original or newly established) operating specifications.
Third-Party Refurbishers and Remanufacturers of Sterilizers
Examples
Remanufactured
If a third party has purchased a used steam sterilizer and “overhauled” it for eventual resale to a Healthcare provider, the activity they have completed is normally classified as a Remanufacture (the steam sterilizer is not returned completely to the original specification, but instead to a new specification) and a 510(k) from the FDA is required to legally market the product.
Remanufacturing is the only one of the above-defined activities which falls into a category in 21 CFR 807.20 that requires the firm to register and list their product with the FDA. Only a remanufacturer of steam sterilizers is required to submit a 510(k).
Most third-party “overhaul” activities would be classified as remanufacturing and hence their sterilizers would require a FDA 510(k) prior to marketing the product(s). The firm would also be required to register and list their product(s). This information would become public so potential customers could be certain that a firm is behaving within the confines of the law.
A comprehensive Factory Acceptance Test (FAT) would be required to recertify the steam sterilizer following remanufacture. (See DYK #27 for a detailed discussion of PRIMUS Factory Acceptance Testing)
Additionally, the sterilizer must have present all FDA-required labeling.
Refurbished
Again, the only exception to the above discussion is if the third party did all the work required to return the sterilizer completely to its original specifications (parts, plumbing, controls, software, electrical, safety features, etc.). In this case, the activity would be considered Refurbishing. The sterilizer would fully function and be physically the same as when it was originally produced by the respective OEM.
A comprehensive Factory Acceptance Test (FAT) would be required to recertify the steam sterilizer following refurbishment.
Additionally, the sterilizer must have all FDA-required labeling.
Service-Only Providers
The FDA does not actively regulate third-party service providers if they only provide service and do not participate in remanufacturing and/or refurbishing steam sterilizers.
FDA Guidance – Source Documents
What Actions Should You Take?
If you believe a firm is illegally marketing medical sterilizers please contact the FDA District Office with this information (i.e. firm name, product, where sold, etc).
The illegal sale of a Healthcare steam sterilizer is an extremely serious offense that could adversely affect the health and welfare of innumerable patients.
More information
PRIMUS PRI-Furb™ Units
Please ask us about DYK #59 – a detailed discussion of PRIMUS’ steam sterilizer refurbishment program – PRI-Furb™ or talk to Dave Schall at 877.679.7800 x1212 or email at dschall@spire-is.com.
Have a question or having difficulties? Talk to Dave Schall, our PRIMUS sterilizer expert who is here to assist you anytime at 877.679.7800 extension 1212 or email at dschall@spire-is.com.
Visit our website at www.spire-is.com