This article explains the challenges reprocessors face in obtaining 510(k) clearance for reprocessed single-use devices when they are not the OEM.
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 is substantially equivalent to the single-use device produced by the original equipment manufacturer (OEM). The FDA also released a guidance document regarding reprocessed single-use devices.
Obtaining 510(k) clearance for a device your company did not design can be challenging, because information requirements that are trivial for the OEM can be extremely difficult to provide for a reprocessor of the device. The following sections of a 510(k) submission pose unique challenges for reprocessed single-use devices:
- Section 13, Labeling – What should and should not be included in the reprocessed device labeling
- Section 15, Biocompatibility – How to identify the materials, and determine what biocompatibility testing needs to be done
- Section 18, Performance Testing – Strategies for determining appropriate performance testing
Section 13, Labeling of 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 important to also include the OEM’s model number. Instructions for use should include:
- Indications for Use, which must be equivalent to the OEM indications.
- All of the necessary warnings and cautions and basic operating instructions needed to safely operate the device.
- The instructions for use may also instruct the user to reference the OEM instructions for use for additional information.
- Instructions on handling of the device after use, with the likelihood that the device will be returned to the reprocessor to repeat the cycle.
Section 15, Biocompatibility
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 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 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 in Section 15 of your 510(k) submission.
Section 18, Performance Testing
There are three main 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. Other testing is specific to the reprocessing and 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 on-line. A redacted copy of the OEM 510(k) is also helpful.
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 the design and/or testing of the device. To determine if the reprocessed device has any applicable standards, you should search the product code of the reprocessed device, as well as the product code of the OEM device if they are different, in the FDA product classification database. Recognized standards applicable to the reprocessed device will be listed in the search results.
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 also need to do a chemical test to ensure there is no residual detergent or cleaning residues remaining on the device. You also need to 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 preparation of your 510(k) submission, you might be interested in a course Mary Vater and Rob Packard created for AAMI. Rob Packard will be the lead instructor for the course pilot in May: 510(k) training course. You can also schedule a call with us by clicking the button below.