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Kentfield, CA 94904
In "Reusing Catheters and Other Medical Devices" [1], after discussing an adverse event, the authors describe what was done clinically and then administratively. The article mentioned that the radiologist and hospital informed their professional liability carriers, who then appointed legal counsel, and that expert review followed. However, the article does not state that the United States Food and Drug Administration (FDA) itself was notified. This reporting is mandatory. I am writing to correct this apparent oversight (either the FDA was not notified—in violation of federal regulations, or the notification was not mentioned in the article), because this article may serve as a reference for radiologists who have similar issues with reprocessed single use devices (SUDs).
Under the medical device reporting regulation (21 C.F.R. 803), hospitals are subject to the same reporting requirements as manufacturers. 21 C.F.R. 803.50 (a)(1) states, "...as a SUD reprocessor, report adverse events to FDA within 30 calendar days when information reasonably suggests that a SUD reprocessed by the hospital may have caused or contributed to a serious injury to a patient at the facility." The requirement is shortened to 10 days for a user facility, and 5 days if the event involves a remedial action [2]. These requirements are in addition to the hospital's other adverse event reporting requirements, already in place.
The article [1] also mentions, in general terms, that there are "a variety of governmental provisions designed to ensure that the...reprocessed products themselves are safe" and that "reprocessing and reusing single-use medical devices should be undertaken in accordance with applicable FDA regulations." Radiologists should be aware of some provisions and regulations that may affect their day-to-day practice:
Reprocessed SUDs must be labeled [3]. Radiologists should thus know how their hospital labels a reused device and should look for that label.
Hospitals are required to keep records of device corrections or removals. Radiologists should thus communicate decisions not to reuse a SUD to the appropriate individual in charge of compliance.
The new FDA provisions do not apply to "open but unused" single-use devices [4].
Radiologists may not be aware that a hospital may not only resterilize but can also repair equipment.
Radiologists should be aware of what devices, in addition to some catheters, are reprocessed in their facility, for example, biopsy forceps.
To whom can a radiologist turn for additional advice? The article mentions "experts in federal laws and regulations that govern such reprocessing" as a resource. More specifically, radiologists should have a line of communication with their safety officer or safety committee. Part of the safety committee function mandated by the Joint Commission on Accreditation of Hospitals includes equipment management and, in some cases, reporting under the Safe Medical Device Act. This is particularly important for hospitals that are part of a network. Although a radiologist may be aware of an isolated incident in his or her own department, a safety officer may determine that the occurrence is part of a trend across facilities. The FDA makes such determinations at a larger level.
Finally, the article [1] states that "radiologists and medical clinics are generally free to implement policies" and that "there is at present no federal or state law or regulation that specifically prohibits the reprocessing and reuse of single-use devices." FDA rules do not state this explicitly, but many safety professionals believe, reading between the lines, that the FDA enacted "Enforcement Priorities for Single Use Devices Reprocessed by Third Parties and Hospitals" [4] in part to discourage the practice by hospitals and to keep it with third-party reprocessors. In other words, radiologists should know that the FDA has given radiologists a yellow light, rather than a green light.
In summary, the reuse of SUDs is a complex topic. Radiologists should be aware of some of the provisions of the regulations that may impact their day-to-day practice.
References
Massachusetts General Hospital Harvard University School of Medicine
Boston, MA 02114
Rush North Shore Medical Center Skokie, IL 60076 Rush Medical College
Chicago, IL 60612
In commenting on our article [1], Dr. Shratter is indeed correct in pointing out that the United States Food and Drug Administration (FDA) subjects hospitals to FDA marketing and manufacturing requirements traditionally applied to manufacturers of single-use medical devices and that these requirements do not apply to opened but unused products. In addition to reporting, labeling, and other requirements noted by Shratter, hospitals engaged in reprocessing single-use devices must adhere to regulatory provisions requiring registration and listing [2], tracking [3], quality system regulation [4], and premarket clearance or approval [5]. These provisions are highly technical, and a complete discussion of them is far beyond the overview provided in our article.
Shratter also takes note of our general statement that there are "a variety of governmental provisions designed to ensure that the...reprocessed products themselves are safe" and that "reprocessing and reusing single-use medical devices should be undertaken in accordance with applicable FDA regulations." This passage alludes to the "general controls" applicable to all medical devices and now applicable to hospitals that reprocess single-use products, "special controls" that may exist for class II devices, and device-specific requirements for class III products [6]. Because these requirements are extremely technical and vary widely among groups of devices and even among individual products, a detailed discussion of them is also beyond the scope of our article.
Finally, Shratter suggests that the FDA is implicitly discouraging hospital-based reprocessing, although he acknowledges that there is nothing in the revised regulations that explicitly supports this contention. Although the FDA has repeatedly emphasized patient safety and regulatory equity between hospitals that reprocess single-use devices and those firms that originally manufactured those products, it has not, to our knowledge, ever publicly stated that hospital-based reprocessing should not occur. That is not to say that the new policy will not have an impact on such reprocessing, only that one should be careful in attributing specific motives to such a complex policy.
We agree with Shratter that the regulatory implications of reprocessing single-use medical devices, quite apart from the malpractice implications of the practice that were the primary focus of our article, are quite complex indeed. Given this complexity, it is not an operation that should be undertaken lightly, nor with only the information offered in our article [1] and Shratter's letter. Safety officers and committees are certainly important, but true compliance will probably require the involvement of legal and regulatory professionals who not only are knowledgeable of FDA marketing and manufacturing regulations but also have the ability to apply that knowledge to the hospital environment.
References
807
(2000)
821 (2000)
820
(2000)
807, 814 (2000)
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