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Infection Control Today magazine's 2002 virtual roundtable on medical device reprocessing
Alliance Medical Corporation
10232 S. 51st Street
Phoenix, AZ 85044
Infection Control Today: What is the reasonable margin of safety that patients and healthcare personnel should expect from reprocessed medical devices?
Alliance: Healthcare personnel and patients can and should expect the same margin of safety for a reprocessed device as for a new product delivered from the original manufacturer. Anything less is unacceptable.
Infection Control Today: Is reprocessing still considered to be good science and why?
Alliance: Absolutely. Proper reprocessing is an exact science based on thorough, painstakingly precise and rigorously monitored cleaning, testing and sterilization procedures and protocols. These are device-specific to ensure that a reprocessed device will perform as originally intended. At Alliance, our biomedical engineers use scientific practices to capture detailed data confirming or rejecting our ability to safely reprocess a device. Annual scientifically designed validations provide proof of cleaning, packaging and sterility. The Food and Drug Administration (FDA) inspects all reprocessing operations and requires the same documentation for each device that the original manufacturer submits. For Class II devices this means a 510(k); Class III devices require a PMA.
Infection Control Today: What steps is your company taking to ensure that the original equipment manufacturers' specifications are met when reprocessing medical devices?
Alliance: In order to develop reprocessing protocols for a specific device, Alliance first performs comprehensive documentation reviews, by examining existing 510(k)s, patents and medical device reports (MDRs). Alliance's biomedical engineers evaluate new devices through an extensive reverse engineering process. With information gained during these processes, we develop device-specific testing criteria to ensure that each device performs as intended after it is reprocessed. In more and more cases, original manufacturers are working with Alliance to provide necessary data to ensure that their products can be reprocessed, so they are not eliminated from consideration by healthcare providers. If it's a Class II device, which is likely since most devices reprocessed by third-party reprocessors fall into this category, we must also submit a 510(k) to the FDA, just like the original manufacturer of the device. This document details the device's characteristics and the cleaning, sterilization and testing procedures used to reprocess the device. The device can only be reprocessed if the FDA clears the 510(k).
Infection Control Today: Obviously hospitals are trying to cut costs by turning to third-party reprocessing, while OEMs are lobbying hard against this practice; in this battle over dollars and sense, can patient safety be safeguarded while free enterprise is protected?
Alliance: The FDA has leveled the playing field by applying the same rules to reprocessors and medical device manufacturers. Not only does this entail the submission of 510(k)s and PMAs, but third-party reprocessors undergo the same FDA inspection as that performed at an OEM. Hospitals should ask to review a reprocessor's FDA inspection report called an Establishment Inspection Report, which is only issued when a reprocessor or device manufacturer is in compliance with the FDA's regulations. It's also important to remember that device manufacturers, not the FDA, designate a device as "single-use." In many cases, this is done by the manufacturer to limit liability and increase sales, not because the device warrants such a label. In some instances, reusable devices have been reclassified as single-use without significant changes in design or materials. Reprocessing drives efficiency in healthcare by offering hospitals a way to save significant sums of money without changing device preferences or practice patterns. For financially strapped hospitals, which include most hospitals in the US, these savings can be used to bolster patient care.
Infection Control Today: Can those high-risk, Class III devices ever be safely reprocessed, and should patients be told prior to a medical procedure that reprocessed instruments and devices will be used?
Alliance: Except for the Ablation Electrophysiology (EP) Catheter, which is nearly identical to its Class II cousin, the Diagnostic EP Catheter, Alliance does not believe that Class III devices can or should be reprocessed. By their nature, Class III devices are high-risk. Alliance focuses on low-risk Class I or II devices. With FDA regulating single-use device reprocessing as stringently as it regulates manufacturers and with premarket submissions now required prior to the reprocessing of most devices, informing a patient regarding the use of reprocessed devices is not necessary, just as informed consent is not necessary when a patient receives a generic, rather than a brand named, medication. The generic drug companies have demonstrated to the FDA that their generic drugs are equivalent to the brand-name version, just as Alliance has demonstrated that its reprocessed devices are substantially equivalent to the new device.
Infection Control Today: How closely are you, as a third-party reprocessor, going to monitor adverse events in hospitals related to malfunctioning reprocessed devices, and how will your company address such an event in case it occurs?
Alliance: Alliance, like all reprocessors, must and is following FDA's Medical Device Reporting (MDR) requirements, which mandate that any injuries related to a device failure or malfunction must be reported. Alliance performs comprehensive reviews to determine the cause of any device malfunction. While OEMs have filed more than 16,000 MDRs on the same types of new devices that Alliance reprocesses, during the same time period, the entire membership of the Association of Medical Device Manufacturers, the trade association for reprocessors, filed only five MDRs. It's also important to keep in mind that third-party reprocessors focus on low-risk Class I and II devices that are not likely to harm a patient if they should fail.
Infection Control Today: What is the most common misconception about the reprocessing of medical devices and how do you address it?
Alliance: The most common misconception is the lack of understanding about the science on which reprocessing is based and the overall sophistication of the industry. When hospital personnel tour our facility, we frequently hear the comment, "Wow, we had no idea that reprocessing is so complicated." The best way to address this misconception is to educate concerned healthcare professionals, such as infection control practitioners, about reprocessing through magazine forums like this one as well as tours, videos, our website, brochures and tradeshows. We believe that most informed healthcare practitioners see the value in reprocessing.