In 2000, the FDA began to view and regulate all companies reprocessing single-use medical devices in the same way it viewed and regulated original equipment manufacturers (OEMs). Before returning reprocessed devices to providers for use, these reprocessors must conduct studies and submit all required 510(k) documentation to the FDA as if they were seeking to market a new device. The 510(k) documentation indicates the reprocessed device is as safe and effective as the original version of the device.
"Essentially what we are obliged to do when we submit our 510(k) documentation is specify a device's design characteristics," says Bruce Lester, PhD, vice president of R&D for reprocessor SterilMed. "We do that by spending time disassembling these devices, finding out how they are put together, what they are made of, the identity of the polymers and lubricants, how they're constructed and then we begin to test for functionality, cleanliness and for sterility to ensure our processes will result in clean, sterile and functional devices."
In some respects, reprocessors must meet even stricter requirements than the OEMs. Since reprocessors will reprocess some devices several times, the companies must demonstrate that the device does not degrade during repeat reprocessing.
"If we say a device can be reprocessed four or five times, we must test this device repeatedly and run it through simulated use," Dr. Lester says. "The simulated uses are worst-case situations and then we show validation for these scenarios. The idea is if you can clean or bring the device back to function or sterilize it from the worst cases then you can certainly do it for the intermediate stages."
The reprocessing processes vary amongst the reprocessing companies but all must meet these requirements as well as other regulations and periodic inspection audits. If physicians at your ASC are hesitant to consider using reprocessed devices, it is helpful to learn more about the process from reprocessing company representatives and, if possible, visit a reprocessor for a tour and demonstration. These experiences will help alleviate concerns over the safety of using reprocessed equipment.
To provide you with an initial understanding of some of the extensive tests reprocessed devices might go through before returning to an ASC for additional uses, Dr. Lester highlights five of the critical steps in SterilMed's reprocessing of a harmonic scalpel, an instrument commonly used by ASCs for minimally invasive and open surgery.
1. Onsite preliminary decontamination. One of the first steps in the reprocessing process might occur in your ASC. SterilMed suggests that ASCs put the devices through their on-site decontamination process. "Our notion is that the way you can clean these things most easily is you have to do some preliminary decontamination on-site," Dr. Lester says. "It doesn't need to be an extensive process. For the harmonic scalpel, it might be as simple as a rinse or short soak in a detergent solution that digests protein or lipids, or simply wiping it off with an antiseptic wipe before putting it in the retrieval bin. That really increases the number of devices that can effectively be reprocessed."
2. Decontamination. Once collected at your ASC, the device is shipped to the reprocessing facility. SterilMed then conducts its own extensive cleaning and decontamination process. Devices are cleaned and decontaminated using various, stringent and proprietary procedures, Dr. Lester says.
In the case of a device like the harmonic scalpel, the team at SterilMed takes great care in examining each individual device during the process. For example, they are particularly concerned with a potential contaminant finding its way past the first bushing that holds the scalpel shaft. "The harmonic scalpel shaft is a titanium shaft that vibrates at very high rates and there are little bushings that center the blade and hold the inside of the shaft so that you get proper frequency," he says. "Sometimes tissue or blood might get by that first grommet so we're very concerned with making sure we evacuate that chamber, clean it and check the jaw pad," which presses the tissue up against the scalpel blade itself.
During this process, the scalpel will go through several different processes to not only ensure the device is decontaminated but also to remove all fluid that was used in the cleaning of the device. "It's very important to remove that fluid because it can act as a shield against ethylene oxide," a gaseous sterilant used by many OEMs, Dr. Lester says.
3. Individual visual inspection. Every device is visually inspected by trained professionals, Dr. Lester says. These individuals are looking for a number of problems that could lead to SterilMed rejecting the device for reprocessing. These include any nicks, scratches, discoloration, physical abnormalities and other damage — anything out of the ordinary from a brand new device. If any flaws are present, the device is recycled and not sent back for re-use.
"The people inspecting these devices might have seen hundreds each day allowing them to note visual flaws more readily," he says. In addition, the inspectors have pictures in front of them which show exactly what disqualifies the device from being accepted. It is at this point that we make a decision as to whether or not the device has passed and is something that can be returned to an end-user."
4. Generator tests. Many of the devices SterilMed reprocesses, including the harmonic scalpel, are plugged into generators or power supplies when they are used by physicians for procedures. These generators often have their own set of internal self-tests to ensure the device is in working condition. For example, the harmonic scalpel would be plugged into the Ethicon Harmonic Scalpel Generator 300 to test the scalpel, and this generator is extremely sensitive in picking up the frequency of the device. Dr. Lester says. SterilMed will plug the scalpel it is reprocessing into this generator and run the internal tests.
"The diagnostic self-test used by the generator produces an ultrasonic signal at a frequency near the device's own resonance frequency," he says. "When internal phase and impedance detectors in the generator indicate that the resonance matches a specific and known range characteristic of the blade it indicates the physical status of the blade. If there's any sort of discrepancy whatsoever, it will reject the blade — for example, if there's a flaw in the blade, if there's a nick, if there's debris or even water — we've actually seen this generator pick up any sort of moisture left on the device."
5. Sterilization. One of the final steps in the reprocessing process is sterilization of the device. To confirm the success of its sterilization process, SterilMed will validate it by spiking test devices with microorganisms and then re-testing them after sterilization to ensure the process kills all microorganisms, Dr. Lester says.
"Particularly we want to make sure it kills these microorganisms much better than the biological indicator which goes along with these devices as they are sterilized," he says. "That biological indicator tells the quality inspector that the ethylene oxide sterilization process has been successful. This is accomplished by doing what is called a 'zero time' or chamber filling incubation with ethylene oxide. The chamber is then evacuated and we compare the number of killed spiked spores with the biological indicator spores killed to insure that the BIs are more resistant to ethylene oxide sterilization." SterilMed utilizes an industry leader in sterilization, Steris Corp., for all sterilization activities. Steris is a major provider of sterilization programs for many of the OEMs.
After completion and validation of the sterilization process, the scalpel is then shipped out to ASCs for re-use.
Learn more about SterilMed.