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Reader: Consent and its role in reprocessed SUDs

To the Editor: I read with interest the article about the study by the Center for Patient Advocacy involving reprocessed single-use devices (SUDs) in the February 2003 issue of Healthcare Risk Management. Included in the article is advice about obtaining informed consent when using these devices. Interesting information, but, there are other perspectives on the issue.

Although Neil Kahanovitz, MD, notes that the use of SUDs "is a safety issue for patients," other than the opinions of the health care providers in the polls, he provides no evidence that patient safety is truly at risk.

In testimony by David Feigal, MD, MPH, director of the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) before the House Committee on Commerce, Subcommittee on Oversight and Investigations on Feb. 10, 2000, Feigal noted that a review of Medical Device Reports submitted to the CDRH between August, 1996 and December, 1999, "[f]rom this data, we can discern no pattern of failures with reused SUDs that differs from patterns observed with the use of SUDs."

Although Feigal also mentions that it is difficult to draw absolute conclusions about the safety of such devices, my own experience as a risk manager has been that infections traced back to devices have, without exception, involved reusable devices, not reprocessed single-use devices. Improper sterilization is apparently the culprit in these cases, not the device itself.

With respect to the issue of informed consent, most state laws require the disclosure of "material risks" to patients. In the absence of any compelling data to suggest that reprocessed single-use devices have a higher degree of risk associated with their use than original SUDs, there really isn’t anything to disclose. With respect to many of the reprocessed SUDs in use in the acute care setting, physicians and nurses would not be able to identify which is which under any circumstances.

If a hospital uses the services of established, FDA-compliant third-party processors, the risk of infection or failure associated with reprocessed devices is demonstrably no greater than new ones.

Consequently, as a greater risk in the use of reprocessed SUDs has not been clearly established, their use does not constitute a "material risk," obtaining special consent for their use is simply not necessary. As we know, given the choice between a used device and a new one, patients would invariably choose the new one, irrespective of any qualitative differences between the two. It’s human nature.

If we agree that, based upon current information, the risks associated with the use of reprocessed SUDs are not demonstrably different than with new ones, the results of these consent discussions could be expected to lead to greater, unnecessary expense to the hospitals and a surge in profits for the manufacturers. Interestingly, manufacturers are insistent about the desirability of obtaining patient’s informed consent when using reprocessed devices, but not for new ones.

As the overwhelming majority of reported cases to the CDRH involve failures and problems with new devices, not reprocessed ones, I believe that device manufacturers may have an ulterior motive in adopting their position on this issue.

Mark Cohen, ARM, RPLU, CPHQ, CPHRM
Risk Management Consultant
Sutter Health
Sacramento, CA