Kinetic Concepts Inc. (NYSE:KCI) is the first manufacturer to take up a new Food & Drug Administration program for labeling home-use medical devices.
The San Antonio, Texas-based device maker will voluntarily submit labeling to the FDA as part of the agency’s medical device Home Use Initiative, a 10-month pilot program for manufacturers to submit labeling of home-use medical devices to a central website.
The FDA launched the new initiative in April, aiming to improve the safety of complex medical devices used to treat patients in their homes, such as hemodialysis systems, wound care and intravenous therapy devices.
The agency believes posting the labeling data will improve access to information about the safe use of the devices for patients and caregivers. The FDA will also implement measures to enhance post-market surveillance of home-use devices, using “HomeNet,” part of its Medical Device Surveillance Network adverse event reporting program.
Several models from KCI’s V.A.C. suite of negative-pressure wound therapy devices are FDA approved with an indication for home use.