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?
