Infection Control Today - 10/2001: Instrumental Knowledge

New Regulations Clear the Way for Third-Party Reprocessors

By Pamela J. Furman, Esq.

Thereprocessing of medical devices labeled for "single use" is standardpractice in US hospitals. For more than two decades, hospitals have been safelyreprocessing a variety of "single use" devices, includingcardiovascular instruments such as electrophysiology (EP) catheters, endoscopicand laparoscopic instruments such as clamps and dissectors, general operatingroom instruments such as compression sleeves and tourniquet cuffs, andorthopedic and arthroscopic devices such as blades and drill bits.¹

Historically, most reprocessing has been conducted with the hospital'scentral service department. However, because of recent changes in the US Foodand Drug Administration (FDA) reprocessing regulations, a growing number ofhospitals are choosing to contract with third-party reprocessors. This articledescribes the FDA's new regulatory framework for reprocessing. It then explainsthe benefits of using third-party reprocessors, and provides hospitals withguidance on how to select a suitable third-party reprocessor.

Regulatory Background

On August 14, 2000, the FDA announced a new approach for regulating thereprocessing of medical devices originally labeled for "single use."The FDA's "Guidance for Industry and for FDA Staff: Enforcement Prioritiesfor Single-Use Devices Reprocessed by Third Parties and Hospitals"establishes a regulatory framework for reprocessing under which the agencysubjects both third-party and hospital reprocessors to the same requirementswith which original device manufacturers currently must comply.² Forhospital reprocessors, this constitutes a dramatic change. Indeed, pursuant tothe new regulatory scheme, hospital reprocessors will--for the first time--beregulated as device manufacturers, subject to the following FDA requirements:

• Establishment Registration and Medical Device Listing. Hospital reprocessors will be required to register with the FDA and provide the agency with medical device listings for the "single use" devices they reprocess.³

• Medical Device Reporting. Hospital reprocessors will need to report certain device-related adverse events to the FDA.⁴

• Medical Device Tracking. Hospital reprocessors could be required to establish tracking systems that would enable certain devices they reprocess to be promptly located in the event that corrective action is needed.⁵

• Reports of Corrections and Removals. Hospital reprocessors will be required to maintain records of, and report to the FDA, certain voluntary field actions undertaken to address health risks posed by devices they reprocess.⁶

• Quality System Regulation (QSR). Hospital reprocessors will need to ensure that their reprocessing operations comply with the FDA's QSR regulation, which contains requirements pertaining to the methods, facilities, and controls used for the design, manufacture, packaging, labeling, storage, installation, and servicing of finished devices.⁷

• Labeling. Hospital reprocessors will need to comply with the FDA's general labeling controls.⁸

• Premarket Requirements. Hospital reprocessors will be required to prepare premarket review applications and obtain agency clearance or approval before reprocessing certain "single use" devices.⁹

• As of August 14, 2001, hospital reprocessors must be in compliance with all of the "non-premarket" requirements listed above, (i.e., registration and listing, medical device reporting, device tracking, corrections and removals, QSR, and labeling). Premarket requirements, in contrast, are being "phased in." On February 14, 2001, premarket submissions were due for the highest risk--or Class III--devices. Premarket submissions for non-exempt, moderate risk--or Class II--devices were due August 14, 2001. Most low risk--or Class I--devices are exempt from premarket review.¹⁰ However, for the few non-exempt Class I products, premarket submissions must be submitted by February 14, 2002.

Benefits of Third-Party Reprocessing

Third-partyreprocessors typically function as extensions of hospitals. Rather than sendingused medical devices to its own central sterile department, a hospital sendsthese devices to a third-party reprocessor, which cleans, functionallytests/inspects, tracks, packages, and sterilizes the devices before returningthem to the hospital. Under this arrangement, the hospital retains ownership ofits devices throughout the reprocessing process.¹¹

For a number of reasons, hospitals increasingly are turning to third-partyreprocessors. First, as described above, under the FDA's new regulatory scheme,hospitals that choose to reprocess in-house will be regulated as devicemanufacturers. Coming into compliance with applicable FDA controls will be acostly and burdensome undertaking that hospitals can avoid by outsourcing to athird-party reprocessor. Unlike hospitals, third-party reprocessors historicallyhave been regulated as device manufacturers, and have been required to complywith all of the "non-premarket" requirements discussed above.¹²Thus, for third-party reprocessors, premarket review represents the only"new" requirement imposed by FDA's recently introduced regulatoryscheme.¹³

In addition, many hospitals have said they now find third-party reprocessingto be more cost-effective than reprocessing in-house. Indeed, hospitals thatcontract with third-party reprocessors are not only able to outsource theregulatory "headaches" associated with in-house reprocessing, but theyalso can avoid the considerable expense associated with establishing andmaintaining an in-house reprocessing center. Likewise, hospitals that utilize anadequately insured third-party reprocessor may be able to minimize the potentialmalpractice costs that could arise in connection with the improper reprocessingof medical devices.

Choosing a Third-Party Reprocessor

Any potential cost savings are irrelevant unless a hospital is confident thatits third-party reprocessor is providing reprocessed devices that are as safeand effective as new devices. The reality is that not all third-partyreprocessors are equivalent, and, as such, hospitals should deliberate carefullybefore choosing a reprocessor.

As a first step, many hospitals convene a "reuse committee" tostudy how they might benefit from reprocessing and to identify potential devicesfor reprocessing. Ideally, a reuse committee should be composed of all therelevant "stakeholders," such as physicians, nurses, in-house counsel,risk managers, infection control, central sterile, materials management, andquality assurance personnel.

Next, a hospital can get a good sense of how various reprocessors compare byasking a number of questions:

Does the reprocessor comply with all applicable FDA requirements?

Reprocessing in compliance with applicable FDA requirements helps to assurethe safety and efficacy of reprocessed devices. It is important to inquirewhether a reprocessor under consideration is adhering to all of the "non-premarket"requirements discussed above, and has submitted premarket review applications inaccordance with the agency's new regulatory scheme for reprocessing.

Does the reprocessor functionally test/inspect all of its devices?

Functional testing/inspection is critical to ensuring the safety and efficacyof reprocessed devices. It is important to select a third-party reprocessor thattests/inspects all of its reprocessed devices, rather than merely a sampling.

Does the reprocessor track the devices it reprocesses?

Tracking, or the process of monitoring a reprocessed device, enablesreprocessors to collect important safety/efficacy information (e.g., thenumber of times a device has been reprocessed), and helps ensure that devicesare not "co-mingled" (i.e., that a hospital receives only itsown devices upon completion of the reprocessing regimen). Contracting with athird-party reprocessor that utilizes a sophisticated tracking system provideshospital personnel with peace of mind.

Does the reprocessor have sufficient liability insurance?

Should a reprocessed device fail due to improper reprocessing, it isimportant that the third-party reprocessor in question possess adequateliability insurance. Hospitals should ask potential reprocessors how muchliability insurance they have, and what their policy covers.

Measuring Success

Once a hospital has implemented a third-party reprocessing program, it isimportant to monitor the program to ensure that patient safety standards arebeing maintained, and that the hospital is realizing the maximum benefits fromthe program. Specifically, the hospital should examine the devices received fromthe reprocessor to ensure that device quality standards are being met. It alsois prudent to survey hospital staff, (e.g., physicians and infectioncontrol personnel, to gauge their level of satisfaction with the devicesreprocessed through the hospital's third-party reprocessing program). Finally,hospitals should monitor the savings they are achieving through reprocessing andperiodically review the new devices they are purchasing in order to identifyadditional candidates for reprocessing.

Third-party reprocessing can present an attractive alternative for hospitalsthat wish to reap the benefits of reuse without subjecting themselves to FDA'sdevice manufacturer requirements. The selection of an appropriate third-partyreprocessor requires careful deliberation and thorough scrutiny. Above all, ahospital must be confident that the reprocessor it selects will deliverreprocessed devices that are as safe and effective as new devices.

Pamela J. Furman, Esq., is executive director of the Association ofMedical Device Reprocessors (AMDR). She is also a principal at Olsson, Frank andWeeda, P.C., a food, drug, and medical device law firm in Washington, D.C.