Posted 12 December 2012
By Alexander Gaffney, RF News Editor
The US Food and Drug Administration (FDA) has released a new medical device draft guidance intended to assist manufacturers in designing and developing devices used by a patient in their own home-so-called "home use" devices.
The devices covered include infusion pumps, cold packs, oxygen supplies, CPAP machines, wheelchairs, walkers and more. As defined by FDA, they are any device capable of being used outside of a professional healthcare facility or clinical laboratory. Since April 2010, FDA has been particularly interested in the devices, launching a Medical Device Home Use Initiative it said is aimed at supporting the safe use of the devices in the home.
The initiative has also been dutifully posting regular case studies regarding home use devices, including cases of patient deaths, odd device malfunctions and cases of unfortunate human-device interactions, such as a wheelchair patient who grabbed onto the accelerator switch of his chair when he sneezed, causing him to careen into his television set. That case could have been prevented had the switch been further away from the wheelchair's movement joystick, FDA said.
The 12 December issuance of the guidance, Draft Guidance for Industry and FDA Staff - Design Considerations for Devices Intended for Home Use, is a part of this home use initiative, FDA explained. "The draft guidance is intended to improve the design and quality of home use devices to eliminate or reduce errors that occur during use," FDA wrote on its website. "It provides recommendations that take into account the device user, the use environment, the device itself, and its labeling." The guidance takes into account many recommendations received through a May 2010 workshop, FDA added.
At the core of FDA's concern with this class of devices is one fact: The devices are being used much more commonly by consumers. That's due to a variety of factors, FDA explained. Consumers, and in particular the "baby boomer" generation, are aging, requiring more in-home healthcare options; medical advancements have resulted in chronic diseases being more manageable, often with the help of devices; and a focus on cost-management in home healthcare settings has spurred the growth of the home use market as payors would rather pay for a few devices for a person's home than nursing home care.
And that's fine, writes FDA. Such devices "provide significant benefits to patients and families, including quality of life improvements and cost savings." But so, too, do those devices pose what FDA calls "unique risks" resulting from the use of the device, the environment in which the device is used and the device itself.
FDA's guidance is primarily focused on the latter of those risk factors-the device itself-which FDA hopes can be designed to take the former two factors-use and environment-into account.
"These risks are best addressed at the design stage," FDA wrote. "Failure to adequately consider certain factors during the design of home use devices may result in inappropriate use, use error, or incompatibilities between the use environment and the home use device. This may lead to hazardous situations or cause the device to malfunction, possibly contributing to death or serious injury."
Put simply, companies need to be focused on "designing risk out of the device," FDA added.
The Design Considerations guidance speaks to many of the ways companies can do that, starting with its references to the Quality System Regulation (QSR), which FDA notes addresses the concept that well-designed devices need to meet the performance and design needs of their intended users. Considerations to take into account include design, cleaning, disinfection and sterilization procedures. A device might function perfectly, for instance, but unless it is able to be easily cleaned by a 70-year-old person, it might pose health disks due to bacterial infection.
Sponsors should also consider enacting a risk management plan describing how the company plans to mitigate the hazards and risks of the device.
Software, too, plays a crucial component in many home use devices, and FDA explains that they should be thoroughly developed and tested as to be straightforward and user-friendly. Methods for updating the software should also adhere to a "least burdensome" and "lowest risk" principle, FDA said.
Much of the remainder of the guidance deals with the environmental and use factors pertinent to the maintenance and use of devices. In light of the potential for power shortages, manufacturers should consider designing their devices with battery back-up options to power them. They should also be designed to meet the needs of various environments, including ones with high levels of humidity, high or low temperatures, low air flow, environments with children (i.e. childproof devices) and physical stresses found in the movement of a device from location to location.
As the guidance is still in draft form, FDA said it will accept comments for the next 90 days. It is expected to be officially published in the Federal Register on 13 December 2012.