Home healthcare and the use of medical devices outside of the professional healthcare environment are on the rise. Modern medicine allows us to live longer and provides those with chronic diseases the ability to receive medical care at home. Examples of home-use devices are oxygen concentrators, hospital beds, sleep apnea monitors, body-worn nerve and muscle stimulators, and dialysis machines, just to name a few.
According to the NAHC (National Association for Home Care & Hospice), approximately 7.6 million individuals are receiving home healthcare in the United States from roughly 17,000 paid providers. Not only does home healthcare improve recipients’ quality of life, but it also provides cost savings. Looking at the chart below, you can see the cost advantages to receiving care at home.
Despite the advantages, employment of devices outside of professional healthcare facilities increases the risk of harm through unintended or potential misuse, driving an even greater need for devices to be designed using human factors principles to mitigate these risks.
In the past, manufacturers of home healthcare equipment were required to comply with IEC 60601-1, demonstrating that their designs mitigate the risks associated with use in the home by patients or caregivers. In 2010, a new provision, IEC 60601-1-11 was published, turning attention specifically towards Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in Home Care Applications. Also in 2010, the FDA started the Medical Device Home Use Initiative to "ensure the safety, quality, and usability of devices labeled for home use." Accordingly, the agency states that it will take the following actions to support the safety and safe use of medical devices in the home:
- Establish guidelines for manufacturers of home-use devices;
- Develop a home-use device labeling repository;
- Partner with home health accrediting bodies to support safe use;
- Enhance post-market oversight; and
- Increase public awareness and education.
These steps will help address the challenges associated with the use of medical devices in the home and provide greater protections for patients receiving home healthcare.
As part of the initiative, a new draft guidance has been written to help manufacturers "design risk out of the device." Draft Guidance for Industry and Food and Drug Administration Staff, Design Considerations for Devices Intended for Home Use is meant to provide advice and summarize other guidance documents available to manufacturers, citing over 24 documents and international standards. It is important to remember that the guidance was created to help manufacturers understand all variables that should be taken into account when designing a home-use device, but that it is not possible to follow all of the guidelines simultaneously. Designers should follow the guidelines to the extent possible, which will help the FDA to evaluate the device’s requirements, functionality, and safety.
How are “home-use devices” and “environments” classified?
A home-use device is a medical device intended for users in any environment outside of a professional healthcare facility or clinical laboratory. The term includes devices intended for use in both professional healthcare facilities and homes.
A user is a lay person such as a patient (care recipient), caregiver, or family member who directly uses a device or provides assistance to the patient in using the device.
A home is any environment other than a professional healthcare facility or clinical laboratory where a device may be used.
Note that the word "home" is being used loosely to mean ANY location in which you use the device outside of a professional healthcare facility or clinical laboratory. Thus, it could be your primary home, your vacation home, your car, public transportation, outdoors, or any other non-clinical location.
It is vital to take into consideration the potential environment(s) where the device may be used. Just a few of the challenges are:
- There may be few electrical fixtures and they may not be up to code;
- The lighting may be poor;
- The home could be quieter or louder than a hospital environment. For example, children or a loud TV can add to noise level;
- Homes, vehicles, and public spaces are not always designed to mitigate maneuverability barriers; and
- Sterility and cleanliness in a home will not be the same as in a clinical setting.
So what should manufacturers do when designing their next home-use device? Consider the following high-level summary based on my review of ANSI/AAMI HE75:2009, Section 25, on home healthcare and the draft guidance on home use:
- The User - Front and center to the design of any product is the user. Who is the ultimate user of the device: the patient, the caregiver, a visiting nurse, or other person? Can the device be used by the intended population? Might the user have sensory, cognitive, or physical limitations? For example, is the device designed in such a way that someone with dexterity issues can use it properly without having to ask for help? Can they hear audible feedback from the device and see the screen well enough?
- The Use Environment(s) - Just as important as the user, the use environment must be strongly considered. Is the device stationary or mobile? Whether in the home or on the go, it is not possible to rely on proper power outlets and thus would require an alternative power source (e.g., batteries). If alarms are part of the device, manufacturers must ensure that they can “be heard in uncontrolled noise environments typically found in the home." Also consider whether the device will be permanently attached to the user in both private and public settings. How will the user bathe? Will it be comfortable when he or she is sleeping? Should it be made as inconspicuous as possible? How will he or she get through security scanners? The use environment(s) also will play heavily into design considerations as it relates to durability, potential exposure to the elements, and whether or not it can safely function in the expected conditions.
- Device Considerations - Multiple guidance documents exist to aid in the design process, offering a mix of regulations and advice. Manufacturers will find considerations related to such things as:
- Design controls and software;
- Learnability and intuitiveness;
- Sound;Labeling; and
The standards and guidance documents can assist manufacturers in developing safe, usable products. However, home-use devices still require extensive testing with the intended users—in simulated environments and later in actual home-use environments—to ensure their usability, understandability, and safety. If manufacturers consider the human factors that are specific to home-use devices, then they, their users, and the healthcare system as a whole will realize the benefits.