In April 2010, FDA announced its "Medical Device Home Use Initiative." The aim of the plan is to provide greater protection for patients who receive home healthcare. According to FDA, many home use devices provide no instructions or instructions that are not suitable for lay caregivers to follow. With the hopes of improving the instructions, FDA has created a pilot program that enables manufacturers of home devices to submit their labeling electronically to the agency. The instructions will be posted in a central location on FDA's Web site, which makes it easier for caregivers to find what they need.
KCI's president and CEO says about the initiative, "We not only commit to take this important and needed step, but believe in the FDA's broad goal of putting patients and safety first."