Updated: Mar 10, 2022
Is your sterile processing department (SPD) reprocessing reusable or single-use medical devices off-label? If so, you may be considered a manufacturer and thus required to follow FDA regulations. The FDA states, "Third Party and hospital reprocessors of single-use devices are subject to all the regulatory requirements currently applicable to original device manufacturers. In the CDC document Guideline for Disinfection and Sterilization in Healthcare Facilities (2008), the CDC states, "the user assumes liability from any injuries resulting from off-label use." Manufacturer instructions for use must be followed when reprocessing medical devices. Not doing so increases the chances of hospital-acquired infections occurring.
Common reprocessing issues found in SPD departments:
Not following the sterilizer manufacturer's guidelines for use
Not following the container/wrapper manufacturer's guidelines for use
Not following the device manufacturer's guidelines for use
Reprocessing single-use items (although this is less frequent, may occur during the Covid-19 pandemic)
Sterilizer manufacturer's guidelines for use include specifics about approved cycles, trays per load, pounds (LBS) per load, and maximum tray weights. Overloading a sterilizer cycle or reprocessing an instrument tray beyond the scope of validation by the sterilizer manufacturer is an off-label use. Also, utilizing unapproved sterilization parameters is an off-label use.
Sterilization containers manufacturers provide guidance in their instructions for use (IFU) on cleaning, inspecting, packaging instruments, sterilizing, and storing sterile products. The IFU includes sterilization modalities for each container design with validated cycle parameters within the sterilization instruction guidelines. Using containers in unapproved modalities is an off-label use along with using unapproved cycles. Instrument weight is also a critical component. Manufacturers following the FDA recommendations to utilize the AAMI ST77 guideline include a maximum instrument+container weight of 25 Ibs. However, not all containers are validated for the 25 Ibs threshold. Different container sizes call for different maximum weight capacities.
Similar to guidelines from container manufacturers, the manufacturers of sterilization wrappers provide guidance on wrapping methods, package weight, sterilization, and storage. Sterilization modality and cycle parameters are included. Specifically, approved tray content weights may change depending upon which modality is being used (e.g., Steam, Sterrad, VPro, or EO) and with the wrapper's thickness or model designs. Using single-use wrappers outside of their validated process is an off-label use.
Device manufacturer IFUs typically contain instructions on the cleaning, inspection, packaging, and sterilization instructions. The sterilization instructions can vary from a minimal standard to a precise specification. Sterilizing any medical device outside of the approved sterilization cycle and modality is an off-label use.
Single-use devices should not be reprocessed unless the manufacturer provides guidance. The only circumstance that this applies to is unused re-sterilizable devices. Reprocessing single-use devices have specific FDA regulations that must be followed. Your processes must be validated, from cleaning through sterilization, and must follow the Good Laboratory Practice standards.
Reprocessing medical devices using an off-label process increases the risk to your patients of acquiring an infection. Hospital sterilization departments do not have the capacity to validate the cleaning and sterilization processes following the FDA guidelines. There are 3rd parties that can provide support in establishing protocols for off-label use and 510k submissions if you have a specific need that is not met by your supply chain. The legal ramifications of not establishing good practices in your sterile processing department can be catastrophic to your business. It may also be catastrophic to someone's life.
For more information on this topic please refer to the documents below. If you have any questions please reach out to us here at Evolved Sterile Processing Consulting.
At Evolved Sterile Processing, our consultants have a greater focus on sterile processing. With our decades of experience, we will help you develop better processes and educational resources for your staff.