FDA Launches Home-Use Medical Device Pilot Program

 Posted on April 23, 2015 in FDA

Every year, more than 7 million patients receive home health medical care under the direction of their medical providers. Many such cases require the use of medical devices in the home to treat or maintain a wide variety of conditions. The devices are put to use by the patient directly, or with the help of a caregiver or family member. While, to a certain extent, home health providers may be able to offer a degree of training in the proper utilization of a home-use medical device, federal regulators have expressed concern over the lack of a standardized labeling format for the devices.

Home-use medical devices include a wide range of equipment, including more simple things like canes and crutches, to more complicated items such as infusion pumps, glucose monitors, and continuous positive airway pressure (CPAP) machines. According to the U.S. Food and Drug Administration (FDA), there have increasing reports of adverse events related to medical devices used in the home, many of them related to the unavailability of the manufacturers instructions.

Over the course of time, and many devices are used in the home for years, the original packaging and documentation can easily be lost or separated from the equipment. This can create problems for a family member or new caregiver who may be unfamiliar with the proper use of the medical device. For a “lay user” without formal training, the device label and package insert may be his or her only possible resource to facilitate the device's proper use.

Last week, the FDA announced that it is moving forward with a pilot program to develop an online repository for home-use device information. On a voluntary basis, manufacturers are being asked to submit an electronic version of instructions, labels, and package inserts to be entered into database made available through the FDA's website. The aim is to create a centralized resource for patients and caregivers to be able to find the information they need as quickly and easily as possible.

The program is set to run throughout the second half of 2015. Evaluations will be made regarding the effectiveness of the database, as well as the administration's submission system. In doing so, the FDA hopes to improve home-use medical device safety and protect patients from unnecessary mistakes due to the absence of proper labeling and instructions.

Using a medical device incorrectly can lead to serious health problems and injuries. Defective medical devices, even when used correctly, can create equally, if not more, serious problems. If you have been injured by a defective medical device, contact an experienced Crystal Lake personal injury attorney to discuss your options. Call today to schedule your free phone consultation.