If you are a third-party or hospital reprocessor, learn how to prepare an FDA eSTAR 510(k) submission for reprocessed single-use devices.
Why is there so much interest in reprocessed single-use medical devices?
With increasing pressures on the medical device industry to make healthcare more affordable, there has been a push to reprocess and reuse single-use devices. Reprocessors obtain used devices from healthcare facilities. The reprocessors clean, process, resterilize, repackage, and relabel devices. Reprocessors must obtain FDA 510(k) clearance by demonstrating that the safety and effectiveness of the reprocessed device are substantially equivalent to the single-use device produced by the original equipment manufacturer (OEM). The FDA created a FAQ document for single-use devices, and three guidance documents were published:
- Labelling recommendations for single-use-device reprocessed by third parties and hospitals (July 2001)
- Reprocessing Medical Devices in Health Care Settings – Validation Methods and Labeling
- Validation Data for 510(k) of Reprocessed Single-Use Device (September 25, 2006)
Why do reprocessors have difficulty preparing an FDA eSTAR for reprocessed single-use devices?
Obtaining 510(k) clearance for a device your company did not design can be challenging because the reprocessor doesn’t have access to all of the required design and manufacturing information. The following sections of the FDA eSTAR submission pose unique challenges for reprocessed single-use devices:
- Labeling – What should and should not be included in the reprocessed device labeling
- Biocompatibility – How to identify the materials, and determine what biocompatibility testing needs to be done
- Performance Testing – Strategies for determining appropriate performance testing
Labeling Section of the FDA eSTAR for reprocessed devices
Labeling of reprocessed devices consists of the instructions for use and the packaging label(s). Device package labeling may also direct the user to both the reprocessor’s IFU and the OEM’s IFU. If you are referencing the OEM’s IFU, it is also important to include the OEM’s model number. Instructions for use should consist of:
- Indications for use, which must be equivalent to the OEM indications.
- All of the necessary warnings and cautions and basic operating instructions needed to operate the device safely.
- The instructions for use may also instruct the user to reference the OEM instructions for use for additional information.
- Instructions on the handling of the device after use, with the likelihood that the device will be returned to the reprocessor to repeat the cycle.
Biocompatibility Section of the FDA eSTAR
Biocompatibility data is more challenging to provide if you replace or modify original components. If reprocessing does not modify the OEM device whatsoever, you can claim that the materials are identical to the OEM device. Therefore, the reprocessed device does not require biocompatibility testing. However, the reprocessor still needs to evaluate the biological risks associated with the reprocessing of the device by testing for cleaning and sterilization residuals. This involves testing for cleaning agent residuals and EO residual testing (ISO 10993-7), if applicable. If applicable, this involves testing for cleaning agent residuals and EO residual testing (ISO 10993-7)
If you replace any of the components during reprocessing with a new component that is identical in dimension and material to the OEM component, minimal biocompatibility testing will be required. If the exact material used by the OEM is unknown, reprocessors can perform material identification testing to determine the material used, and then create the replacement part out of the same material.
If you modify or replace any patient-contacting components on the device such as lubricants, insulation, etc., with components that are different from the OEM, then you will need to perform additional biocompatibility testing to prove that the new or modified material is biocompatible. This testing will depend on the duration of contact and where will the material contact the patient. The new material will also need to be listed in your device description and Section 15 of your 510(k) submission.
Performance Testing Section of the FDA eSTAR
There are three primary sources for identifying performance testing requirements of reprocessed devices:
- OEM Testing listed in the OEM 510(k) submission
- Predicate Testing listed by another reprocessor of an equivalent device
- Product Standards listed under the product classification code for the reprocessed device or the OEM device
You should reference a predicate device that has been reprocessed and the OEM device to identify performance testing. Some testing is specific to the functional performance of the device. For these tests, you need to compare performance side-by-side against the OEM. Another testing is specific to reprocessing; you will reference the predicate device. Sources of information regarding the required tests for each of these devices can be found in the 510(k) summaries of the respective devices. If possible, it’s helpful to select a predicate that has a redacted 510(k) available on the FDA’s website. If a redacted 510(K) is not readily available, you may request a redacted copy through the Freedom of Information Act online. A redacted copy of the OEM 510(k) is also helpful. It’s helpful to select a predicate with a redacted 510(k) available on the FDA’s website if possible
If testing information is not as readily available in the 510(k) summary, you will determine the essential performance functions of the device, and design tests to evaluate and compare the OEM device and the reprocessed device for those functionalities. Some devices have specific standards for their design and/or testing. To determine if the reprocessed device has any applicable standards, you should search the product code of the reprocessed device and the product code of the OEM device, if they are different, in the FDA product classification database. The search results will list recognized standards applicable to the reprocessed device.
Additional tests that may be needed to validate reprocessing include residual protein, residual carbohydrates, and the presence of hemoglobin. These tests ensure that all biological material from previous use is removed. If you are not performing biocompatibility testing on the reprocessed device, you must do a chemical test to ensure no residual detergent or cleaning residues remain on the device. You must also determine how many reprocessing cycles the device can survive before performance degradation. This can be done by repeating simulated use, reprocessing, and performance testing until a statistically relevant decrease in the performance of the device is observed.
If you have additional questions regarding preparing your 510(k) submission, please visit our Contact Us webpage to schedule a meeting with Lindsey Walker or Rob Packard.