Getting an FDA Clearance to Sell Reprocessed Single-Use Medical Devices
An FDA listing and FDA clearance of all the devices we do is a requirement for Innovative Health. Regular inspections of the facilities take place, and we adhere to several standards for facility operations, processes, and metrics. Since Innovative Health is a regulated medical facility, our focus on patient safety permeates everything we do. The best example of this is how we approach getting a clearance from FDA to sell reprocessed single-use medical devices. I get lots of questions about this.
Before Innovative Health even starts working on documents to ask FDA for a clearance to reprocess a device, staff across a number of departments evaluate whether it should be reprocessed for another use. Engineering looks at whether the device can be cleaned and whether it functions similar to a new device, after being reprocessed. The regulatory team examines the MAUDE database, a public database of device failures to determine if device failure is a concern from a patient risk standpoint. The quality department also looks at the device features and designs to determine that materials don’t degrade - and they check the work of the engineering department.
We also receive clinical input from our team of clinical integration specialists and from physicians at our research partner hospitals. Operations evaluate whether the device can be reprocessed using the current operations configuration and practices, or if changes need to be made. Finally, marketing and sales evaluate how market perceptions impact the future success of the product: Will physicians be concerned about using a reprocessed device? Are there contractual barriers to hospitals acquiring the device?
In short, the process of deciding to reprocess a certain device is a highly systematic process that involves several departments and several cross-functional meetings before the paperwork for FDA is even prepared. The decision is not just about what makes money. Much more is involved, including a comprehensive risk assessment, assessment of feasibility, looking at the cleaning process, determining how to test and inspect the device, and development of validation techniques and methods.
Once we have decided that it is worthwhile looking at getting an FDA clearance, we work to determine the feasibility of reprocessing the device. This means evaluating whether we can clean the device – and inspect it to ascertain that the device is not only clean, but also clear of any debris, scratches to inner lumens, etc. We also perform scientific examination of the materials used in the device prior to determining that a device can be reprocessed. In short, we need to determine that materials are not degraded during the cleaning process. To do this, quality staff has to determine what material is used on different areas of the device. They use Fourier transform infrared (FTIR), the preferred method of infrared spectroscopy, to determine this. This analysis results in a material characterization report.
Before we apply for a clearance to reprocess a device, a submission has to be prepared. This is a very extensive document that essentially explains how Innovative Health plans to go about reprocessing the device, and how this can be done safely by ensuring that the reprocessed device is substantially equivalent to a new device.
The submission includes a substantial amount of data, produced by Innovative Health quality staff or by external laboratories. After submission, FDA sends out an acknowledgement letter with a so-called K-number, and conduct a 15-day review to determine is the agency can accept the submission. A lead reviewer is assigned, and FDA takes 60 days to review the data submitted. Often, the agency sends out a request for additional information that needs to be submitted, before the clearance is granted.
Only after we receive the clearance, can we start selling the reprocessed device. This can take months or even years, depending on the complexity of the devices.