By David Lennarz, Vice President and Co-Founder of Registrar Corp
On March 24, 2015, the U.S. Food and Drug Administration (FDA) offered a webinar to review the agency’s guidance “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling” that was published last week. The webinar was presented by Elaine Mayhall from FDA’s Office of Device Evaluation and Geetha Jayan from FDA’s Office of the Center Director. Mayhall and Jayan said the purpose of the guidance was to provide recommendations to device manufacturers for developing reprocessing instructions that can be easily understood and followed by users because proper reprocessing plays an important role in reducing the risk of patient infections from reusing devices.
Mayhall and Jayan said the recommendations in the guidance are applicable to four types of devices:
- Reusable devices that are initially supplied sterile to a user and require the user to reprocess the device after each patient use
- Reusable devices that are initially supplied non-sterile to a user and requiring the user to process the device prior to initial use, as well as after each use
- Reusable devices that are intended for reuse by a single patient and need to be reprocessed between each use
- Single-use devices that are initially supplied non-sterile and require a user to process the device prior to its use
These devices must be cleaned and then either sterilized or disinfected, depending on their contact with patients. The processes used to clean, sterilize, or disinfect a particular device must be validated by FDA. Cleaning, disinfecting, and sterilization are distinctly different processes and require separate validation. FDA recommends that device manufacturers consider reprocessing needs in the early stages of designing a device and use designs that make it easy for users to affectively implement the process.
The new guidance replaces FDA’s 1996 guidance titled “Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities.” The guidance was expanded to include information regarding the validation of reprocessing methods and instructions and provides greater clarity on documentation to be provided in different premarket submissions (510(k), PMA, de novo, etc.). Mayhall and Jayan said the guidance puts specific emphasis on the importance of proper cleaning, testing worst-case scenarios, and designing devices that are less challenging to reprocess.
Mayhall and Jayan discussed FDA’s six criteria for writing reprocessing instructions:
1. Instructions should reflect the intended use of the device.
What constitutes appropriate instructions depends on many factors, such as if the device has direct or indirect contact with patient, the design of device, the intended use of the device, if any toxic chemicals were used on the device, etc.
2. Instructions should advise users to thoroughly clean the device.
Adequate sterilization and disinfection depend on a thorough cleaning.
3. Instructions should indicate the appropriate microbicidal process for the device.
The appropriate microbicidal process for a device depends on the device’s Spaulding Classification. A device can be critical, semi-critical, or non-critical. Critical devices are introduced directly into the blood stream or contact a normally sterile tissue or body-space during use. Critical devices should be thoroughly cleaned and sterilized after each use. Semi-critical devices contact mucous membranes or non-intact skin. They usually do not penetrate tissues or enter normally sterile areas of the body. Semi-critical devices should be thoroughly cleaned and sterilized. If sterilization is not possible, semi-critical devices can undergo high-level disinfection. Non-critical devices only contact intact skin and do not penetrate it. Non-critical devices should be thoroughly cleaned and then undergo either intermediate or low level disinfection, depending on the contamination.
4. The instructions should be feasible and only include legally marketed devices and accessories
Device manufacturers should consider the location where the device is likely to be used. Disinfection and sterilization methods need to be feasible for users to implement, and the equipment and accessories needed to implement the instructions should be readily available to users. A manufacturer should not suggest something like radiation sterilization, as this is usually only available at a manufacturing facility and therefore would not be readily available to users.
5. Instructions should be comprehensive
Mayhall and Jayan said the instructions should help the user understand precisely how to conduct the entire reprocessing procedure safely and productively. The instructions should be so simple and specific that a lay person or patient could do it in their home. The instructions need to cover every detail. For example, if a user needs to rinse the device, the instructions should indicate the necessary water quality and temperature and how long to continue rinsing. The instructions should describe how and when to disassemble a device and should list the cleaning agents or the class of cleaning agents to use.
The instructions should instruct the user to inspect the device after reprocessing and, if the device does not appear clean, to repeat the process or dispose of the device. Mayhall and Jayan said the instructions should always include the manufacturer’s contact information.
6. Instructions should be understandable
Instructions should use simple language and should be clear, logical, sufficiently detailed, and written in sequential order. Mayhall and Jayan suggested including charts, diagrams, and pictures.
FDA will review the reprocessing procedures and instructions for a device when it conducts the pre-market review for the device. All cleaning, disinfection, and sterilization validations should be completed before the pre-market application is submitted. Mayhall and Jayan identified particular documentation required for specific pre-market submissions:
PMA, HDE, and de novo: Protocols and complete test reports of validation of reprocessing instructions
510(k): Manufacturers of a subset of devices should include data to validate their reprocessing instructions. Validation data may also be requested for substantial equivalence.
IDE: Summary of the validation of reprocessing instructions
Mayhall and Jayan ended the webinar with three key messages of the guidance:
- Reusable device labeling should include instructions for reprocessing and reusing devices and accessories safely
- All cleaning, disinfection, and sterilization processes should be validated
- Labeling should provide sufficiently detailed reprocessing instructions
Registrar Corp is a U.S. FDA consulting firm that helps medical device establishments comply with FDA regulations. Our Regulatory Specialists can help device manufacturers determine whether or not FDA’s reprocessing guidance applies to their products, as well as review their device labels for FDA compliance. For questions or assistance with FDA regulations for medical devices, contact Registrar Corp at +1-757-224-0177 or receive help from a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.
