The US Food and Drug Administration (FDA) has finalized a draft guidance intended to clarify how manufacturers should design and develop medical devices primarily used by a patient in their own home—so-called "home use" devices.
FDA released the draft version of the guidance in December 2012 as part of its 2010 "Home Use Initiative." As explained by FDA, the initiative is intended to "support the safe use of medical devices in the home." For example, FDA has been working to standardize medical device labeling and is working on building an online repository for labeling information, both of which are intended to make it easier for consumers to easily access information about their devices.
Home use devices are, as their name suggests, devices which are used in home healthcare settings, either by a patient or a caregiver. As defined by FDA, they are any device capable of being used outside of a professional healthcare facility or clinical laboratory. Home use devices include infusion pumps, cold packs, oxygen supplies, CPAP machines, wheelchairs, walkers and more.
Because the devices are typically used frequently by those without medical training, FDA has taken an interest in making sure that they are designed appropriately for use within the home. The agency has already compiled dozens of case studies to illustrate how seemingly benign features or flaws can lead to patients being harmed or even killed.
For example, FDA cited a feeding pump used to feed a baby. After the pump was hit with a power surge, its feeding rate reset to 10 times its normal rate, resulting in a child being overfed and dying of "a necrotic bowel situation."
Draft Guidance Basics
FDA's guidance was intended to prevent this case, and others, by asking manufacturers of medical devices to focus more on the design and quality of home use devices in order "to eliminate or reduce errors that occur during use."
FDA said it hoped devices could be designed to better take into account a product's use and the environment in which it is used. "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. That includes the device itself, as well as software used to control the device's functions.
FDA is now out with a final version of the guidance document, Design Considerations for Devices Intended for Home Use.
As FDA explains in an accompanying Federal Register announcement, the guidance contains relatively few changes relative to the original draft guidance.
Some changes, however, are notable. For example, FDA's new definition of "home use device" now includes devices which are used in "outdoor environments, office environments, schools, vehicles, emergency shelters, and independent living retirement homes." Some within industry had complained that FDA's definition of "home" was overly restrictive. FDA did not address, however, concerns that nursing home environments should be included under the guidance.
Another notable change is FDA's elimination of a requirement that devices should be "childproof." That provision has been entirely removed from the final guidance, and replaced with a cautionary note that, "You should consider that children or adults might interact with the device in inappropriate ways."
Another addition to the guidance regards storage. FDA says that manufacturers should "provide information to the user about proper storage of the device and its components and accessories." Some devices may need to be kept out of direct sunlight, be stored at a certain temperature, or be kept dry, for example.
FDA also calls for manufacturers to consider developing a "risk management plan" to identify potential hazards, estimate and control risks, and monitor the effectiveness of any controls.
Design Considerations for Devices Intended for Home Use (FR) (Docket)