MedSun Hospitals Lend Data to Congressional Testimony
MedSun: Newsletter #9, November 2006

In testimony before the U.S. House of Representatives Committee on Government Reform,
Daniel Schultz, M.D., Director of the Center for Devices and Radiological Health (CDRH) at the
Food and Drug Administration (FDA), referred to feedback received from MedSun facilities in addressing the issue of reprocessed single-use devices (SUDs). Dr. Schultz noted that FDA has been actively engaged in the issue for some time, with the agency’s efforts including research, outreach, premarket review, inspections, and compliance investigations. FDA believes that, taken together, these efforts have provided and will continue to provide reasonable assurance of safety and effectiveness of reprocessed SUDs for patients.

Dr. Schultz’s remarks on MedSun during the September 26, 2006, Committee meeting included the following text:
“FDA’s Medical Product Safety Device Network (MedSun) is comprised of over 350 hospitals that have been recruited and specifically trained to identify and report device problems. The hospitals in this program are broadly representative of U.S. healthcare facilities. FDA staff talked with representatives from more than 50 of these facilities to obtain feedback on their experience with using reprocessed SUDs.

“The MedSun respondents who gave us feedback represented various occupations in hospitals, including materials management, biomedical and clinical engineering, risk management, infection control, surgical services, nursing staff, supply utilization, and equipment management. Staff being interviewed responded overwhelmingly that they view the use of reprocessed SUDs as providing a significant cost savings to their facilities and as being an environmentally sound practice.

“There was considerable variation in the devices being reprocessed at the various facilities and the degree of acceptance of this practice by individual practitioners within the facilities. None of the participants we spoke with reported specific problems with SUD-related infections, but they also pointed out that, if an infection occurred, it would be difficult to discern whether the reprocessed SUD was the cause. It also is interesting to note that the participants did not report a greater concern with mechanical problems associated with reprocessed SUDs compared to unreprocessed SUDs. In general, the participants had a favorable view of reprocessed SUDs used in their facilities. They also stated that they relied heavily on FDA oversight to ensure safety and effectiveness and to provide objective information on reprocessed SUDs.”


MedSun Newsletters are available at www.fda.gov/cdrh/medsun