New Regulations Clear the Way for Third-Party Reprocessors
By Pamela J. Furman, Esq.
The reprocessing of medical devices labeled for "single use" is standard practice in US hospitals. For more than two decades, hospitals have been safely reprocessing a variety of "single use" devices, including cardiovascular instruments such as electrophysiology (EP) catheters, endoscopic and laparoscopic instruments such as clamps and dissectors, general operating room instruments such as compression sleeves and tourniquet cuffs, and orthopedic and arthroscopic devices such as blades and drill bits.1
Historically, most reprocessing has been conducted with the hospital's central service department. However, because of recent changes in the US Food and Drug Administration (FDA) reprocessing regulations, a growing number of hospitals are choosing to contract with third-party reprocessors. This article describes the FDA's new regulatory framework for reprocessing. It then explains the benefits of using third-party reprocessors, and provides hospitals with guidance on how to select a suitable third-party reprocessor.
On August 14, 2000, the FDA announced a new approach for regulating the reprocessing of medical devices originally labeled for "single use." The FDA's "Guidance for Industry and for FDA Staff: Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals" establishes a regulatory framework for reprocessing under which the agency subjects both third-party and hospital reprocessors to the same requirements with which original device manufacturers currently must comply.2 For hospital reprocessors, this constitutes a dramatic change. Indeed, pursuant to the new regulatory scheme, hospital reprocessors will--for the first time--be regulated 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-party reprocessors typically function as extensions of hospitals. Rather than sending used medical devices to its own central sterile department, a hospital sends these devices to a third-party reprocessor, which cleans, functionally tests/inspects, tracks, packages, and sterilizes the devices before returning them to the hospital. Under this arrangement, the hospital retains ownership of its devices throughout the reprocessing process.11
For a number of reasons, hospitals increasingly are turning to third-party reprocessors. First, as described above, under the FDA's new regulatory scheme, hospitals that choose to reprocess in-house will be regulated as device manufacturers. Coming into compliance with applicable FDA controls will be a costly and burdensome undertaking that hospitals can avoid by outsourcing to a third-party reprocessor. Unlike hospitals, third-party reprocessors historically have been regulated as device manufacturers, and have been required to comply with all of the "non-premarket" requirements discussed above.12 Thus, for third-party reprocessors, premarket review represents the only "new" requirement imposed by FDA's recently introduced regulatory scheme.13
In addition, many hospitals have said they now find third-party reprocessing to be more cost-effective than reprocessing in-house. Indeed, hospitals that contract with third-party reprocessors are not only able to outsource the regulatory "headaches" associated with in-house reprocessing, but they also can avoid the considerable expense associated with establishing and maintaining an in-house reprocessing center. Likewise, hospitals that utilize an adequately insured third-party reprocessor may be able to minimize the potential malpractice costs that could arise in connection with the improper reprocessing of medical devices.
Choosing a Third-Party Reprocessor
Any potential cost savings are irrelevant unless a hospital is confident that its third-party reprocessor is providing reprocessed devices that are as safe and effective as new devices. The reality is that not all third-party reprocessors are equivalent, and, as such, hospitals should deliberate carefully before choosing a reprocessor.
As a first step, many hospitals convene a "reuse committee" to study how they might benefit from reprocessing and to identify potential devices for reprocessing. Ideally, a reuse committee should be composed of all the relevant "stakeholders," such as physicians, nurses, in-house counsel, risk managers, infection control, central sterile, materials management, and quality assurance personnel.
Next, a hospital can get a good sense of how various reprocessors compare by asking a number of questions:
Does the reprocessor comply with all applicable FDA requirements?
Reprocessing in compliance with applicable FDA requirements helps to assure the safety and efficacy of reprocessed devices. It is important to inquire whether a reprocessor under consideration is adhering to all of the "non-premarket" requirements discussed above, and has submitted premarket review applications in accordance 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 efficacy of reprocessed devices. It is important to select a third-party reprocessor that tests/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, enables reprocessors to collect important safety/efficacy information (e.g., the number of times a device has been reprocessed), and helps ensure that devices are not "co-mingled" (i.e., that a hospital receives only its own devices upon completion of the reprocessing regimen). Contracting with a third-party reprocessor that utilizes a sophisticated tracking system provides hospital personnel with peace of mind.
Does the reprocessor have sufficient liability insurance?
Should a reprocessed device fail due to improper reprocessing, it is important that the third-party reprocessor in question possess adequate liability insurance. Hospitals should ask potential reprocessors how much liability insurance they have, and what their policy covers.
Once a hospital has implemented a third-party reprocessing program, it is important to monitor the program to ensure that patient safety standards are being maintained, and that the hospital is realizing the maximum benefits from the program. Specifically, the hospital should examine the devices received from the reprocessor to ensure that device quality standards are being met. It also is prudent to survey hospital staff, (e.g., physicians and infection control personnel, to gauge their level of satisfaction with the devices reprocessed through the hospital's third-party reprocessing program). Finally, hospitals should monitor the savings they are achieving through reprocessing and periodically review the new devices they are purchasing in order to identify additional candidates for reprocessing.
Third-party reprocessing can present an attractive alternative for hospitals that wish to reap the benefits of reuse without subjecting themselves to FDA's device manufacturer requirements. The selection of an appropriate third-party reprocessor requires careful deliberation and thorough scrutiny. Above all, a hospital must be confident that the reprocessor it selects will deliver reprocessed devices that are as safe and effective as new devices.
Pamela J. Furman, Esq., is executive director of the Association of Medical Device Reprocessors (AMDR). She is also a principal at Olsson, Frank and Weeda, P.C., a food, drug, and medical device law firm in Washington, D.C.