This is the third and final installment in a three-part series, looking at the evolution of the reprocessing industry, and empowering providers who are learning to navigate it. Read part one here, and part two here.

By Lars Thording

Since FDA began regulating single-use device reprocessing in 2000, the conduct of single-use device reprocessors—their high standards, their transparency, and their commitment to building a sustainable future for reprocessing—have enabled the broad acceptance of reprocessing among U.S. hospitals. But as new reprocessors enter the market, they must also be held to the high standards that have been established in the industry, particularly when it comes to matters related to patient safety.

Let’s take a look at the questions hospitals should be asking to ensure their partners are prioritizing patient safety within their products, practices, and services.

Commitment to quality
The most important department in a reprocessing company is not the sales department or the engineering department. It is the quality department. Complaint handling and complaint responses must involve the most conservative principles and follow strict procedures. Handling and responding must be swift: Complaints are an important source of information that can result in manufacturing improvement, product holds, etc. If something is wrong with a device, you should expect the reprocessor to stop producing it and find the root cause.

Reprocessors play an important role in detecting changes in manufacturer IFUs, designs, and materials. A strong reprocessor will detect these changes quickly and re-validate their processes. In some cases, reprocessors have been able to detect design changes that potentially could result in added patient risk.

Internal and external audits are key to the integrity of the reprocessor’s quality system. The goal is to have a quality system that exceeds the standards of any reviewer – and a quality system that exceeds the standards of a new device manufacturer.

Questions to ask
• How rapidly do we get answers to complaints?
• Will your complaint responses contain reports of a full investigation – in every instance?
• How does your complaint handling process work? What is involved?
• What do you do when you find that a device failure/complaint is verified by the investigation?
• What is your corrective action plan?
• What are your rules for putting a product on hold?
• What findings did you have in your last FDA inspection?
• What findings have your internal audits produced over the past 24 months?
• How many open Corrective and Preventive Actions (CAPAs) do you have? What are they?
• How long on average are your CAPAs open?

Submissions to and clearances from FDA
The regulatory and engineering process of preparing an FDA submission is time-consuming and expensive. But the reprocessor should not cut any corners. Once again, the reprocessor’s standards should be higher than an original device manufacturer. Consider “the n+1 rule”: If the reprocessor asks to reprocess a device twice for a total of 3 uses, the company must provide data that shows device integrity after three reprocessing cycles (2+1). If devices in transport could be exposed to temperatures of 100 degrees for 24 hours, the reprocessor should put them in the oven at 150 degrees for 48 hours; if maximum strength put on a handle in a procedure is 20 pounds, the reprocessor should test the device at 40 pounds, etc.

One of the things that sets reprocessed devices apart from new ones is that every single device is tested (numerous times) during the reprocessing process. Original manufacturers do not do this. This means that physicians can have a high degree of confidence that the device will work. This is a core principle of reprocessing that should never be challenged.

In an FDA submission, transparency and data integrity is important. The reprocessor should only apply for the products and brands that data supports. The rule is that you cannot include two devices in a submission that have different indications or material design/functionality differences. There have, recently, been situations where clearances have come very easily to new reprocessors, and it could be speculated that “creative” work is the cause. And when the reprocessor utilizes its clearance, you should expect them to be conservative about what devices they consider to fall under that clearance.

Medical device manufacturers and reprocessors use a regulatory pathway called “line extensions” to be able to market devices that may not have received a clearance but are so similar that they can be “folded in” under a previously received clearance. This is dangerous territory, and the practice should be conducted very diligently. Again, from a regulatory standpoint, this is only permissible if the device has the same indication and is materially and functionally similar to the predicate device.

Questions to ask
• How many uses did you test your latest cleared device for? How do you determine how many uses to test for?
• How do you test for material degradation between uses?
• How do you test for the impact of transportation and storage of used devices?
• How do you determine what tests to conduct on a device that is being reprocessed?
• What tests did you go through to obtain your latest clearance?
• What are your last line extensions and which clearances were referenced?
• Did the line extensions have the same indication as the predicate device?
• What are the design differences? Functional differences?

Double-reprocessing concerns
A reprocessor cannot reprocess a device previously reprocessed by another reprocessor. There are two reasons for this:

1. When an FDA clearance is granted to a reprocessor, that clearance is granted to reprocess the device a certain number of times. Reprocessing and reusing beyond this is against regulations. Since there is no convention in the industry for how devices are marked, you are only able to “read” your own devices and discover their history in terms of number of uses. It follows that you risk going against regulation if you reprocess another reprocessor’s device.
2. Different reprocessors with clearance to reprocess the same device may use different methods for cleaning devices. For example, different chemicals may be used in the cleaning process. Using different chemicals may result in reactions in the material that make the device unsafe. For similar reasons, reprocessing open and unused devices is not a safe process unless FDA cleared.

Please note that although clearance-exempt devices and reusable devices do not have an FDA clearance, the same principle applies here, as the number of uses is controlled by other agencies.

Reusable EP cables are an excellent example of this: Although there is no 510(k) clearance, getting ready to reprocess one of the more complex cables takes a lot of time and a lot of money. Material characterization is necessary, as is understanding the potential degradation from reprocessing and sterilization. In many cases, custom fixtures have to be designed and built. Beware of cable reprocessing sold at very low rates: The safety and quality of the reprocessed cable may not be as you should expect.

Questions to ask
• When you receive a device, how do you determine how many times a device has been used?
• What do you do with devices that have been used the maximum number of times?
• What do you do if a device has been reprocessed by another reprocessor?
• If you reprocess these, how do you know how many times they have been used in the past?

By ensuring your partners are committed to best practices in the above areas, you can ensure your organization is maximizing the sustainability, efficiency, safety and overall value of its single-use device reprocessing program.