If the servicing of devices is truly about patient safety, critical device information should not be withheld on the grounds of trade secrets. Moreover, questions exist under applicable trade secret law as to whether the information is truly "trade secret" information if it is provided to some servicers but not other servicers. Is it really secret? Patient safety and pragmatism should control.
IAMERS is requesting that the FDA resolve confusion with respect to FDA’s interpretation of what constitutes the scope of "adequate instructions" particularly with respect to access to service keys, technical information and updates. What, if any, consequences should exist if the manufacturer declines to cooperate?
A manufacturer should not be able to claim that certain necessary instructions will not be provided because the manufacturer claims the information otherwise provided is a "trade secret", or the equipment has reached "end of life" status (a condition determined ahead of time by the manufacturer). Since all of the leading manufacturers engage in multi-vendor servicing programs for healthcare organizations, they, themselves, experience issues with the dearth of information being willingly provided, when they attempt to service devices other than those they manufacture.
The industry, and most importantly the patients, benefit from cooperation in this area. Where policing this area is, as at least one manufacturer has suggested, within the "exclusive" jurisdiction of FDA, we will be very interested in learning how the FDA intends to further address noncompliance with existing regulatory requirements for adequate instructions.
We are grateful to the FDA for its very substantial efforts to receive industry input (including the full participation of senior CDRH leadership in both days of the 2-day workshop). Still, as noted, there are many important questions we are hopeful the answers to which should be clarified in the FDA Servicing Guidance.
Your input is essential. Moreover, while the FDA is in the process of updating certain aspects of servicing, such as its guidance on radiation control regulations (comments to which are due February 15, 2019) it may, as a practical matter, be several years before the FDA formally revisits this servicing guidance area.
About the author: Robert J. Kerwin is general counsel for IAMERS, the International Association of Medical Equipment Remarketers and Servicers.Back to HCB News
