Question of the Month with Comment
MedSun: Newsletter #14, May 2007

Question:
Does your hospital have a policy or process to track faulty devices that are returned to manufacturers for evaluation and analysis? What problems or challenges do you find with the process? Is the process different for single-use products, devices or instruments, or other special cases? (This excludes devices that are sequestered for legal purposes.)

Comment:
For clinical equipment, we have the vendor/manufacturer sign a release form, which we send to the Biomedical Engineering Department. Staff temporarily remove this device from their inventory and then set up a tickler list to contact the manufacturer monthly about its progress in evaluating the problem. For single-use disposable items, a similar process is followed by the Risk Management Department. All potential legal cases are sequestered with both our facility and/or third-party evaluations. Our greatest challenge is that manufacturers often find that the equipment or disposable item "does not have any defect affecting the performance of the device" or that "the device is operating within normal design parameters." Another common response we receive is, "the device was operated in a manner for which it was not designed," but, of course, it obviously failed or we wouldn't be sending it back for evaluation.


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