Wednesday, May 1st 2002
On behalf of the American Hospital Association, the Association of American Medical Colleges, the American Society for Healthcare Central Services Professionals, the Association for Healthcare Resource and Materials Management, the Cleveland Clinic Foundation, the Federation of American Hospitals and the Henry Ford Health System, we are writing to strongly object to a Senate proposal to include in the conference report on the Bioterrorism Preparedness Act of 2001 (H.R. 3448) language regarding the reprocessing of devices labeled by manufacturers as "single use."
The language is unnecessary and burdensome, and would increase the cost of reprocessed devices to hospitals without improving safety or efficiency. The Food and Drug Administration (FDA), working in a cooperative and open process with original equipment manufacturers (OEMs), device reprocessing companies and hospitals, has already implemented a plan under which all device reprocessors are treated as manufacturers and therefore are subject to the very same regulatory requirements. These requirements cover: registration; listing; premarket submissions; labeling; quality systems requirements; medical device reporting; medical device tracking; and device correction and removals.
The proposed language also would implement requirements that go far beyond the FDA's current requirements for a "safe and effective" device. We believe the language is intended to be so burdensome and costly that it puts an end to reprocessing. For instance, the language requires that reprocessors of certain low-risk, simple devices, but not the OEMs, must obtain either a premarket approval or a premarket notification (510(k)) from FDA before the device can be placed on the market. Currently, the FDA exempts most of these Class I devices from premarket submissions, whether manufactured by an OEM or a reprocessor, because they are deemed to be so low-risk and non-invasive that premarket submissions are unnecessary to protect the public. We also do not believe that these devices present a risk of increased infections to our patients.
In addition, the proposed language would mandate additional labeling requirements that, in many instances, may be impossible for reprocessors to meet. The proposed language would require that the reprocessor's name be displayed on the device itself in a manner at least as prominent and at least as permanent as the OEM's name. But many devices that are reprocessed may be too small to comply with this requirement without compromising the device. In fact, OEMs attempted, but failed, to impose a similar labeling requirement on reprocessed devices in a recent Citizen's Petition rejected by the FDA. The proposed language is simply unnecessary, as FDA already requires reprocessed devices to be clearly labeled with the name of the reprocessor and other relevant information.
We believe that a greater concern regarding device labeling is the lack of standards for OEMs that would make the "single use" label meaningful, evidence-based and standardized. Although OEMs have a financial incentive to label devices "single use," the FDA claims that it does not have the statutory authority to require OEMs to justify this labeling. This lack of statutory authority is a more appropriate issue for Congress to address than layering additional and unnecessary requirements upon reprocessors.
Again, we strongly object to the inclusion of this language in the bioterrorism conference report. We strongly urge the conferees to delete these provisions and allow the FDA to continue implementing the process it has already put into place.
Association of American Medical Colleges
American Hospital Association
American Society for Healthcare Central Services Professionals
Association for Healthcare Resource and Materials Management
Cleveland Clinic Foundation
Federation of American Hospitals
Henry Ford Health System