A Brave New World

February 1, 2001

A Brave New World

A Brave New World

By Mark Salomon

The FDA's new guidelines forreprocessors of disposable medical devices have launched hospitals squarely intouncharted waters. Hospitals and the independent companies that clean, repackage,and sterilize devices labeled "single-use" by their makers, such aselectrophysiology catheters, pulse oximeters, and surgical bits and blades, nowwill be regulated the same way original manufacturers are. The guidelines, whichwere almost a year in the making, represent a new regulatory era for hospitals.Until now, the agency has focused its attention on third-party reprocessingcompanies, which have come under FDA oversight for years. However, the new rulesrepresent stepped-up regulation even for third-party reprocessors.

The FDA's Larry Spears concedes the new guidelines will be a big pill forhospitals to swallow. "Hospitals will be affected significantly by proposedchanges in the FDA's oversight of the reprocessing of devices labeled for onlyone use," he told the Association for the Advancement of MedicalInstrumentation in August.1

Hospital administrators, infection control officials, risk managers, centralservice officials, perioperative services personnel, and materials managers willhave to arm themselves with a completely new body of knowledge if they are toassess accurately what this regulatory scheme means for their organizations. Andthey don't have much time left.

What you need to know

Now hospitals that reprocess devices in-house must follow the same rigorouspre-market submission requirements as manufacturers. For every device a hospitalwants to reprocess, it must submit information to the FDA that demonstrates thesafety 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 requirementsknown as "general controls" set out in the FDA guidance document.Agency officials want to use that time to educate hospitals about theirregulatory obligations. The FDA stated in the new guidance that waiting a yearto enforce the regulations shouldn't pose a problem because it has no evidence"to demonstrate that reprocessing and reuse of single-use devices (SUDs) isposing 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-marketnotification and premarket application. How does a hospital knowwhich pre-market process to follow? It depends on which device is chosen.

During the formulation of its guidance document, the FDA first proposed anew, elaborate device classification system. However, after many stakeholdersraised concerns about the system, the agency dropped its plan. Instead, thecurrent Class I, Class II, and Class III system set out in the Code of FederalRegulations forms the basis of the pre-market submission requirements and thetimetable that hospitals must follow. Unless regulations specifically exempt adevice, 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 apre-market approval application (PMA), depending on the device.

Hospitals have until mid-February to get their pre-market submissions to theFDA for Class III devices, and the FDA will have six months to approve thosedevices. The deadline for Class II devices is mid-August. Submissions for ClassI devices are due in February 2002.

The Pre-market Process

There are important differences between the pre-market notification andapplication processes.

The Food, Drug, and Cosmetic Act contains a section labeled 510(k) thatrequires a company to notify the FDA at least 90 days before marketing a medicaldevice. The regulation's intent is for the manufacturer--now hospitals andthird-party reprocessors--to demonstrate to the FDA that its device is as safeand effective as a device already on the market, known as a predicate device.For manufacturers, the regulation applies to new devices; for hospitals andreprocessors, it applies to any device they wish to reprocess.

The applicant submits a document called a pre-market notification to theagency for review. Typically, 510(k) refers to the process of preparing andsubmitting the pre-market notification to the FDA. If the agency agrees that thedevice is substantially equivalent to one already on the market, it grants theapplicant clearance for marketing the device.

The PMA process is more time consuming and burdensome than pre-marketnotification. The applicant must submit valid scientific evidence, usually basedon clinical studies, to the FDA that demonstrates the device is safe andeffective for its intended use.

And because hospitals now are considered manufacturers, the application alsoshould clearly identify manufacturing--in this case, reprocessing--controls.Before approving a PMA submission, the FDA also must inspect a hospital'sreprocessing facilities.

Faced with a Choice

Hospitals that perform their own reprocessing are faced with a tough decisionthat will involve careful deliberation. Many facilities regard the situation ascritical.

The American Hospital Association has made it clear to its members that thosechoosing to continue in-house reprocessing services must be in full complianceby the deadline, which comes only 12 months after the August 14, 2000, releaseof the new regulations.3 That timetable is especially burdensomeconsidering most manufacturers need 24 months to set up shop and begin marketingtheir products. At stake are the cost savings that hospitals have enjoyed fordecades by reusing devices that manufacturers would rather see thrown away afterone use.

Faced with these new, onerous regulations, some hospitals may decide to stopreprocessing devices in their own facilities. According to a June 2000 report bythe US General Accounting Office (GAO), administrators and physicians saidhospitals would be much less likely to maintain in-house reprocessing servicesunder the new regulations.4

Some facilities may choose to stop using reprocessed devices altogether, anoption that will surely drive up costs. Other hospitals may take advantage ofthe economies of scale offered by third-party reprocessors. Surveys show thatmore profit-pinched healthcare providers are now outsourcing a variety ofservices as a way to help manage their operations.5

For hospitals that choose to outsource the reprocessing of their devices, thenew regulatory scheme holds a silver lining. Reprocessing has always been analternative to the wasteful single use of durable medical devices. Now,reprocessed devices will be put through the same processes and will be treatedthe same as newly manufactured devices. The new regulations eliminate any doubtthat a reprocessed device is just as safe and works exactly the same as a newone.

Not all reprocessors are the same, however. Although all third-partycompanies must comply with the new FDA regulations, any hospital consideringoutsourcing of device reprocessing should look for service and quality that goabove and beyond the basics of FDA compliance. Some key factors to consider aredevice durability, patient outcomes, and standards. All criteria should be basedon a solid scientific foundation.

Durability and Outcomes

A quality tracking system is a critical element in providing valuableinformation on the durability of a device. Although tracking is required onlyfor implantable devices, a quality reprocessor will track its devices todetermine scientifically how many times they can be reliably reused. Hospitalsshould ask a reprocessor to what extent the company can provide trackinginformation. A reprocessor that has cleaned, tested, and sterilized millions ofdevices--and tracked those devices with a validated system--can show how durablethe devices a hospital chooses to buy really are. That information, in turn, maygive a hospital insight on which manufacturers are reliable.

Hospitals also should ask whether a reprocessor's quality monitoring systemallows it to track patient outcomes. Extensive validation and highly controlled,predictable protocols allow for the safe reprocessing of millions of deviceswithout adverse patient outcomes. Does the reprocessor participate inpeer-reviewed patient monitoring studies that demonstrate the safety andefficacy of a particular device? If so, hospital staff can ask for documentationthat demonstrates that the company's reprocessing protocols work clinically.

Administrators, infection control officers, risk managers, and others canhave much more confidence in a reprocessor that provides continuous patientmonitoring. Data provided in such a program demonstrate that devices can bereused safely without adverse outcomes.

Quality Standards

Perhaps the most important factor to consider when choosing a third-partyreprocessor is evidence that the company "walks the talk" of thescience of reprocessing. All third-party reprocessors must meet the same FDAregulations. Yet there are differences in the way those companies approach thatscience. A hospital should be aware of those differences. For example, does areprocessor have strict protocols and validated systems for cleaning, testing,packaging, and sterilization? Does its quality systems have accreditation fromother agencies, such as certification to ISO 9001 with a scope of reprocessingmedical devices with design controls? Those points of differentiation canprovide a hospital with an extra layer of confidence in choosing a reprocessor.

Hospital reuse committees also should conduct due diligence by closelyexamining the information in reprocessors' premarket submissions. Hospitals canwatch for substantial differences or instances where a company goes above andbeyond the baseline requirements.

Consider sample size, for example. Does a company use the statisticallyappropriate minimum sample in its testing to demonstrate the safety and efficacyof a device? A minimum sample is all that's required. But how much moreassurance can you have in a study where the sample size is substantially larger?

Another measure to consider is a company's cleaning protocols. Does thereprocessor demonstrate that its protocols are effective against bacterial sporechallenges that represent Colony Forming Units (CFUs) far exceeding the nativebioburden coming out of hospitals? What is the CFU log reduction in cleaningbefore terminal sterilization? In addition, a hospital should take into accounta reprocessor's testing procedures. Look to see if the company clinically teststhe functionality of every device it reprocesses before returning them tohospitals.

A Crossroads

For many hospitals, the new FDA regulations represent a crossroads.Healthcare organizations are faced with a difficult choice. Whether a hospitaldecides to continue in-house reprocessing or outsource the service, any decisionmust be thoroughly researched and carefully deliberated. This decision also mustbe communicated clearly and effectively to the board and staff.

The FDA's regulations also reinforce the fact that hospitals that choose tooutsource can do so with confidence, as long as they do their research andunderstand the differences in reprocessors.

The reuse of medical devices has become a community standard in manyhealthcare markets. Proper reprocessing of medical devices can save a hospitalhundreds 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 andthrow 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 VanguardMedical Concepts Inc. in Lakeland, Fla.For a complete list of references click here