Infection Control Today magazine's 2002 virtual roundtable on medical device reprocessing
Vanguard Medical Concepts
5307 Great Oak Drive
Lakeland, FL 33815
Infection Control Today: What is the reasonable margin of safety that patients and healthcare personnel should expect from reprocessed medical devices?
Vanguard: First, it's important to note that not every device should be reprocessed. One of the guiding principles of the Association of Medical Device Reprocessors is that a device should only be reprocessed if it can be scientifically proven and validated that the device can be cleaned, functionally tested, sterilized and reused without harm to the patient.
The FDA's new regulatory framework eliminates many of the questions that have been raised up to this point about the safety and efficacy of reprocessing SUDs. Reprocessed devices now are put through the same processes and are treated in exactly the same way as new devices coming straight from the manufacturer. Although hospitals across the country have long regarded reprocessing as a safe alternative to the wasteful single use of durable medical devices, the guidance announced by the Food and Drug Administration in August 2000 eliminates any doubt that a reprocessed device is just as safe and works exactly the same as a new one.
For that reason, patients and healthcare personnel can expect the same margin of safety from a reprocessed device that they expect from a new one. In the device industry, the expectation is that less than 1 in 1 million devices will fail. One clear difference between the original device manufacturers and Vanguard is the inspection rate. Every single device that goes through Vanguard's facilities is 100% performance-tested using thorough visual and functional cross-inspections. Manufacturers test only a sampling of the devices that go to market.
Infection Control Today: Is reprocessing still considered to be good science, and why?
Vanguard: Absolutely. Reprocessing of medical devices has always been considered good science. Decades of experience have taught hospitals that reprocessing done right is safe for their patients. Reprocessing is not only good science, it's the right thing to do.
There are myriad standards in place - from packaging to sterilization to biocompatibility -- to ensure that a device isn't altered in any way as it is reprocessed. Vanguard meets all of those standards. And as we grow, we are further refining our understanding of good cleaning technology and taking that technology to new levels. Hospitals can expect to see some breakthroughs in that area that will benefit everyone, from the patient to the clinicians.
Vanguard has reprocessed more than 6 million device - and counting - without a single patient incident. That wouldn't be the case if we didn't base everything we do squarely on the science of reprocessing, which includes: (1) validation to establish that the reprocessed product is like the new product, and (2) a transfer of the validated processes into a manufacturing environment that is tightly controlled to deliver a consistently safe product.
Infection Control Today: What steps is your company taking to ensure that the original equipment manufacturers' specifications are met with reprocessing medical devices?
Vanguard: Before a product is even considered for Vanguard's reprocessing services, it is put through a very regimented program for validating whether it can be safely reused.
One of the top priorities in Vanguard's validation plan is determining that after reprocessing, the product has the specifications necessary to function in its intended use. This is critical, because Vanguard has to prove that the reprocessed product is substantially equivalent to the original manufacturer's device in order to meet the mandatory requirement of filing and securing clearance from the FDA to market our reprocessed products. This happens as a result of the FDA's complete oversight of the reprocessing industry.
After we have validated a product for reprocessing and received clearance to market it as a reprocessed product, we don't take for granted that the product may not change in the future. At Vanguard, devices are 100% inspected for functionality after every reprocessing. We benchmark this product against the functional attributes of a new product developed during our extensive validation process.
Our technicians, who are certified by the National Institute for the Certification of Healthcare Sterile Processing and Distribution Personnel, perform continuous monitoring for any potential changes a device may experience. We trend rejection data specific to a device manufacturer or model type, so we are able to spot significant alterations in Vanguard's manufacturing rejection rates that could be related to a change in the product. If a significant change is detected, we revalidate the process.
In addition, we are consistently reviewing marketing data, original device manufacturers' cleared marketing submissions, and feedback from our clinical customers to assess significant product changes that might alter safe reprocessing of any device we do.
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?
Vanguard: Definitely. Balancing patient safety with free enterprise is not an either/or proposition; both can be accomplished. Today's rapidly advancing technology has incredible benefits for patients, but it also carries a cost for both the hospital and the original equipment manufacturer.
Each year, the healthcare industry discards millions of dollars in otherwise functional medical devices after a single use. There is no question that medical device reprocessing offers a safe, scientific alternative that can help medical facilities realize as much as a 50 percent savings over the purchase price of new medical devices without affecting the quality of patient care.
The healthcare community has long recognized that reprocessing is an option that allows hospitals to provide the best and safest healthcare to their communities. The cost savings realized from reprocessing allows hospitals to redirect those monetary resources back into quality healthcare.
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?
Vanguard: Yes, clearly it is possible, using science and the known standards for biocompatibility, packaging and sterilization. Again, the reprocessing industry recognizes that not every device should be reprocessed, which is why Vanguard, as a member of the Association of Medical Device Reprocessors (AMDR), reprocesses a device only if it can be scientifically proven and validated that the device can be cleaned, functionally tested, sterilized and reused without harm to the patient.
The issue of patient consent often is raised, but there is a very straightforward answer if you think it through. Should patients be told that a reprocessed device will be used in a procedure? There is no question that patient safety is the final measure in the delivery of care. However, the silver lining in the new FDA guidance is that the question of consent becomes moot.
"Informed consent" is the willing acceptance of a medical intervention by a patient after adequate disclosure by the physician of the nature of the intervention, its risks and benefits, as well as of alternatives with their risks and benefits.
The moral question behind the patient consent issue has always been whether the information disclosed adds to the quality of the informed consent. That is why there is no law requiring patient consent for permission to use reprocessed devices. Clearly, a physician's choice to use a reprocessed device over a disposable one -- or one brand of surgical device instead of another manufacturer's -- is never questioned, nor does it require consent.
Reprocessing is no different from either of these situations. In the final analysis, this choice falls within the physician's practice of medicine. I don't know of any physicians who feel that it is important to get consent from the patient.
Now however, under the new FDA guidelines, the safety and efficacy of a reprocessed single-use device is proven in premarket submissions, demonstrating that a reprocessed device is substantially equivalent to the new device. A reprocessed device that is in compliance with general controls and has been cleared by the FDA's premarket submission process poses no more risk to a patient than a new device that goes through the same process. Therefore, because patient consent isn't required for the use of a new device, the question of consent is eliminated for reprocessed devices as well.
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?
Vanguard: We will conduct all necessary monitoring of adverse events related to reprocessed devices. We review on an ongoing basis the FDA's Medical Device Reporting information. In addition, Vanguard is constantly trending data on product complaints where the functionality of a device may not have compromised the patient but the end user didn't receive the expected results. And we continuously examine process and quality improvements in order to provide the best reprocessed devices for our customers.
Under the guidance issued by the Food and Drug Administration (FDA) in August 2000, hospitals and third-party reprocessors are considered manufacturers, and as such must adhere to general controls that include Medical Device Reporting. If a patient becomes ill or is injured after an SUD is reused, or if the device fails, the event must be documented for the FDA under the Medical Device Reporting program. The MDR requirements spell out the circumstances that warrant a report, the timeframe under which it must be filed, and the procedures and medical device complaint files that must be developed and maintained. Vanguard would take all appropriate corrective actions in the case of a device failure. The product would be recalled from the field, and we would either remedy the problem through revalidation or discontinue reprocessing that particular device.
It's important to note that Vanguard has a long history of reviewing devices. Our validated tracking system provides us with information specific to manufacturers and models and indicates any probability of device failure. We maintain an extreme safety margin in providing our customers with functional devices. For example, if we establish that a device can safely be reprocessed 10 times, we will only reprocess it five times.
Infection Control Today: What is the most common misconception about the reprocessing of medical devices, and how do you address it?
Vanguard: The biggest misconception about the reprocessing industry is that it is an unregulated industry. The fact is, reprocessing is and has always been regulated.
It's interesting to note that most OEMs can expect audits of their facilities every three years -- or even less often. Third-party reprocessors typically see audits on an annual basis. In fact, some would argue that we are highly regulated because of the intense scrutiny and frequent auditing of reprocessors that the device manufacturers have clamored for.
Vanguard embraces methods and techniques that foster quality in all of our procedures, and in our continuous improvement and good business practice. From its inception in 1991, Vanguard has followed all general controls set by the Food and Drug Administration. Like the medical device manufacturers, our company is FDA registered and inspected. Even before the FDA issued its new guidance for the reprocessing of SUDs in August 2000, the strict protocols that form the foundation of Vanguard's reprocessing service were subject to the same FDA regulations for Good Manufacturing Practices and Quality Systems Regulation that applied to the original manufacturers.
In support of this commitment, we have has developed a quality system that is registered to ISO 9001 and specifically covers reprocessing medical devices. The ISO 9000 standards represent an international consensus on good manufacturing practices that enable an organization to consistently deliver quality products or services to meet the client's needs. ISO ensures that certified companies maintain their quality system through annual audits conducted by registrars.
Now that the FDA regards hospitals and third-party reprocessors as manufacturers and requires us to follow the same premarket submission requirements, there's a level playing field.