A Brave New World
By Mark Salomon
The FDA's new guidelines for reprocessors of disposable medical devices have launched hospitals squarely into uncharted waters. Hospitals and the independent companies that clean, repackage, and sterilize devices labeled "single-use" by their makers, such as electrophysiology catheters, pulse oximeters, and surgical bits and blades, now will be regulated the same way original manufacturers are. The guidelines, which were almost a year in the making, represent a new regulatory era for hospitals. Until now, the agency has focused its attention on third-party reprocessing companies, which have come under FDA oversight for years. However, the new rules represent stepped-up regulation even for third-party reprocessors.
The FDA's Larry Spears concedes the new guidelines will be a big pill for hospitals to swallow. "Hospitals will be affected significantly by proposed changes in the FDA's oversight of the reprocessing of devices labeled for only one use," he told the Association for the Advancement of Medical Instrumentation in August.1
Hospital administrators, infection control officials, risk managers, central service officials, perioperative services personnel, and materials managers will have to arm themselves with a completely new body of knowledge if they are to assess accurately what this regulatory scheme means for their organizations. And they don't have much time left.
What you need to know
Now hospitals that reprocess devices in-house must follow the same rigorous pre-market submission requirements as manufacturers. For every device a hospital wants to reprocess, it must submit information to the FDA that demonstrates the safety and effectiveness of the device.
The FDA gave hospitals a six-month grace period, which began in August 2000, to begin filing pre-market submissions for the most sophisticated (Class III) devices.
Hospitals have 12 months to comply with other non-pre-market requirements known as "general controls" set out in the FDA guidance document. Agency officials want to use that time to educate hospitals about their regulatory obligations. The FDA stated in the new guidance that waiting a year to enforce the regulations shouldn't pose a problem because it has no evidence "to demonstrate that reprocessing and reuse of single-use devices (SUDs) is posing any imminent danger to public health."2
The general controls hospitals now must comply with are:
- Registering with the FDA and listing all devices being reprocessed.
- Mandatory submission of adverse event reports. 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.
- Meeting manufacturing requirements set out in the Quality System Regulation (QSR). QSR governs the methods, facilities, and controls used in virtually all facets of production: the designing, manufacturing, packaging, labeling, storaging, installing and servicing of all finished devices. For manufacturers and third-party reprocessors, these requirements are not new. However, for hospital reprocessing devices, these regulations may represent unfamiliar territory.
- Meeting device-labeling requirements regarding the name and place of manufacture and inclusion of adequate instructions for use.
- Tracking medical devices. Like manufacturers, hospitals and third-party companies will not be subject to tracking regulations like those for implantable devices (i.e., pacemakers) unless the FDA has ordered that a particular device be tracked.
- Maintaining and submitting to the FDA reports on certain types of device corrections and removals.
Some terms being added to the hospital lexicon are 510(k), pre-market notification and premarket application. How does a hospital know which pre-market process to follow? It depends on which device is chosen.
During the formulation of its guidance document, the FDA first proposed a new, elaborate device classification system. However, after many stakeholders raised concerns about the system, the agency dropped its plan. Instead, the current Class I, Class II, and Class III system set out in the Code of Federal Regulations forms the basis of the pre-market submission requirements and the timetable that hospitals must follow. Unless regulations specifically exempt a device, a pre-market notification is required for Class I and Class II devices. Class III devices may require either a pre-market notification (510k) or a pre-market approval application (PMA), depending on the device.
Hospitals have until mid-February to get their pre-market submissions to the FDA for Class III devices, and the FDA will have six months to approve those devices. The deadline for Class II devices is mid-August. Submissions for Class I devices are due in February 2002.
The Pre-market Process
There are important differences between the pre-market notification and application processes.
The Food, Drug, and Cosmetic Act contains a section labeled 510(k) that requires a company to notify the FDA at least 90 days before marketing a medical device. The regulation's intent is for the manufacturer--now hospitals and third-party reprocessors--to demonstrate to the FDA that its device is as safe and effective as a device already on the market, known as a predicate device. For manufacturers, the regulation applies to new devices; for hospitals and reprocessors, it applies to any device they wish to reprocess.
The applicant submits a document called a pre-market notification to the agency for review. Typically, 510(k) refers to the process of preparing and submitting the pre-market notification to the FDA. If the agency agrees that the device is substantially equivalent to one already on the market, it grants the applicant clearance for marketing the device.
The PMA process is more time consuming and burdensome than pre-market notification. The applicant must submit valid scientific evidence, usually based on clinical studies, to the FDA that demonstrates the device is safe and effective for its intended use.
And because hospitals now are considered manufacturers, the application also should clearly identify manufacturing--in this case, reprocessing--controls. Before approving a PMA submission, the FDA also must inspect a hospital's reprocessing facilities.
Faced with a Choice
Hospitals that perform their own reprocessing are faced with a tough decision that will involve careful deliberation. Many facilities regard the situation as critical.
The American Hospital Association has made it clear to its members that those choosing to continue in-house reprocessing services must be in full compliance by the deadline, which comes only 12 months after the August 14, 2000, release of the new regulations.3 That timetable is especially burdensome considering most manufacturers need 24 months to set up shop and begin marketing their products. At stake are the cost savings that hospitals have enjoyed for decades by reusing devices that manufacturers would rather see thrown away after one use.
Faced with these new, onerous regulations, some hospitals may decide to stop reprocessing devices in their own facilities. According to a June 2000 report by the US General Accounting Office (GAO), administrators and physicians said hospitals would be much less likely to maintain in-house reprocessing services under the new regulations.4
Some facilities may choose to stop using reprocessed devices altogether, an option that will surely drive up costs. Other hospitals may take advantage of the economies of scale offered by third-party reprocessors. Surveys show that more profit-pinched healthcare providers are now outsourcing a variety of services as a way to help manage their operations.5
For hospitals that choose to outsource the reprocessing of their devices, the new regulatory scheme holds a silver lining. Reprocessing has always been an alternative to the wasteful single use of durable medical devices. Now, reprocessed devices will be put through the same processes and will be treated the same as newly manufactured devices. The new regulations eliminate any doubt that a reprocessed device is just as safe and works exactly the same as a new one.
Not all reprocessors are the same, however. Although all third-party companies must comply with the new FDA regulations, any hospital considering outsourcing of device reprocessing should look for service and quality that go above and beyond the basics of FDA compliance. Some key factors to consider are device durability, patient outcomes, and standards. All criteria should be based on a solid scientific foundation.
Durability and Outcomes
A quality tracking system is a critical element in providing valuable information on the durability of a device. Although tracking is required only for implantable devices, a quality reprocessor will track its devices to determine scientifically how many times they can be reliably reused. Hospitals should ask a reprocessor to what extent the company can provide tracking information. A reprocessor that has cleaned, tested, and sterilized millions of devices--and tracked those devices with a validated system--can show how durable the devices a hospital chooses to buy really are. That information, in turn, may give a hospital insight on which manufacturers are reliable.
Hospitals also should ask whether a reprocessor's quality monitoring system allows it to track patient outcomes. Extensive validation and highly controlled, predictable protocols allow for the safe reprocessing of millions of devices without adverse patient outcomes. Does the reprocessor participate in peer-reviewed patient monitoring studies that demonstrate the safety and efficacy of a particular device? If so, hospital staff can ask for documentation that demonstrates that the company's reprocessing protocols work clinically.
Administrators, infection control officers, risk managers, and others can have much more confidence in a reprocessor that provides continuous patient monitoring. Data provided in such a program demonstrate that devices can be reused safely without adverse outcomes.
Perhaps the most important factor to consider when choosing a third-party reprocessor is evidence that the company "walks the talk" of the science of reprocessing. All third-party reprocessors must meet the same FDA regulations. Yet there are differences in the way those companies approach that science. A hospital should be aware of those differences. For example, does a reprocessor have strict protocols and validated systems for cleaning, testing, packaging, and sterilization? Does its quality systems have accreditation from other agencies, such as certification to ISO 9001 with a scope of reprocessing medical devices with design controls? Those points of differentiation can provide a hospital with an extra layer of confidence in choosing a reprocessor.
Hospital reuse committees also should conduct due diligence by closely examining the information in reprocessors' premarket submissions. Hospitals can watch for substantial differences or instances where a company goes above and beyond the baseline requirements.
Consider sample size, for example. Does a company use the statistically appropriate minimum sample in its testing to demonstrate the safety and efficacy of a device? A minimum sample is all that's required. But how much more assurance can you have in a study where the sample size is substantially larger?
Another measure to consider is a company's cleaning protocols. Does the reprocessor demonstrate that its protocols are effective against bacterial spore challenges that represent Colony Forming Units (CFUs) far exceeding the native bioburden coming out of hospitals? What is the CFU log reduction in cleaning before terminal sterilization? In addition, a hospital should take into account a reprocessor's testing procedures. Look to see if the company clinically tests the functionality of every device it reprocesses before returning them to hospitals.
For many hospitals, the new FDA regulations represent a crossroads. Healthcare organizations are faced with a difficult choice. Whether a hospital decides to continue in-house reprocessing or outsource the service, any decision must be thoroughly researched and carefully deliberated. This decision also must be communicated clearly and effectively to the board and staff.
The FDA's regulations also reinforce the fact that hospitals that choose to outsource can do so with confidence, as long as they do their research and understand the differences in reprocessors.
The reuse of medical devices has become a community standard in many healthcare markets. Proper reprocessing of medical devices can save a hospital hundreds of thousands of dollars without affecting the standard of patient care. It is an alternative for hospitals that choose not to use a device once and throw it away.
For a complete list of references, see the Infection Control Today® website at www.infectioncontroltoday.com.
Mark Salomon is senior vice president of corporate development of Vanguard
Medical Concepts Inc. in Lakeland, Fla.
For a complete list of references click here