The Role of Human Factors in Home Health Care Workshop Summary (2010) / Chapter Skim
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8 Medical Devices in Home Health Care--Molly Follette Story
8 Medical Devices in Home Health Care--Molly Follette Story
Pages 145-172
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From page 145... ...
Some medical devices have been used in the home for many years; other devices are just beginning to migrate there; and emergent technologies present new opportunities for health care management in the home. While some of these devices were explicitly designed for use outside formal health care settings by professional home health caregivers as well as the general public, many devices were not.
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From page 146... ...
All of these use factors must be considered in order to ensure that medical devices are safe and effective for people receiving home health care. Historical use of Medical Devices in the Home The most common types of medical devices, found in nearly every home, are used for delivering medications or first aid.
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From page 147... ...
Increasing Migration of Medical Devices into the Home Climbing costs of health care services and hospital stays and shortages of health care facilities and of nurses and other skilled personnel have put pressure on the medical system to provide more care on an outpatient basis. Consequently, the range and complexity of medical devices being used outside formal health care institutions by diverse user populations are increasing.
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From page 148... ...
These professionals are typically associated with home care organizations (e.g., home health agencies, hospices, homemaker and home care aide agencies, staffing and private-duty agencies, companies specializing in medical equipment and supplies) or they may be from registries or operate as independent providers.
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From page 149... ...
• Assistive Technology -- devices used to enhance personal capabili ties, such as sensory abilities or mobility. • Durable Medical Equipment -- includes medical devices used to support performance of basic activities of daily living, such as beds, lifts, and toileting equipment.
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From page 150... ...
Prosthetic device Orthotic device, including braces Cane or crutches Walker Wheelchair Scooter Durable Medical Equipment Hospital bed Specialized mattress Chair (e.g., geri-chair or lift chair) Lift equipment Commode, urinal, bed pan Meters/Monitors Thermometer Stethoscope Blood glucose meter Blood coagulation (PT/INR)
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From page 151... ...
Telephone or internet connections EMERGENT TECHNOLOGIES IN HOME HEALTH CARE Telehealth -- which is health care facilitated by telecommunications technology -- has begun to transform the home care landscape and promises to grow substantially in coming years. Currently, simple technologies (e.g., e-mail, the Internet, cell phones)
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From page 152... ...
Some of the devices envisioned will be embedded in common household objects, such as a biosensing chip in a toothbrush that will check blood sugar and bacteria levels; smart bandages made of fiber that will detect bacteria or a virus in a wound and then recommend appropriate treatment; smart T-shirts that will monitor the wearer's vital signs in real time; and heads-up displays for glasses that use pattern recognition software to help people remember human faces, inanimate objects, or other data. Novel handheld devices may provide new capabilities for home health care, such as skin surface mapping, an imaging technology that will track changes in moles to detect malignancies; biosensors that will perform as portable laboratories; and alternative input devices such as eye blinks (electromyography)
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From page 153... ...
Particularly due to the conditions that require them to need home health care, individuals receiving care at home may have reduced physical strength or stamina (e.g., fatigue associated with chronic pain) , diminished visual or hearing abilities, impaired cognitive abilities (including confusion caused by the effects of medication)
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From page 154... ...
If the human factors demands of the medical device exceed the capabilities of the user, the equipment burden may be too great to manage, and the person receiving home health care may be forced to move to a longterm care facility or a nursing home. In 2005, Hancock, Pepe, and Murphy proposed a "hierarchy of ergonomics and hedonomic needs" (see Figure 8-2)
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From page 155... ...
(User facilities are defined as hospitals, nursing homes, long-term care facilities, and ambulatory and outpatient treatment facilities, including home care and hospice care.) In evaluating reports of adverse device events in the MAUDE database between June 2008 and August 2009, the FDA found 1,059 events for which the location of the event was reported as "home." The devices involved in the greatest number of events were
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From page 156... ...
Infusion pumps, the most frequently reported device on this list, are notoriously complicated to operate and put a particularly high cognitive burden on the user. This is especially problematic because the person receiving infusion tends to be sicker than the typical home health care recipient and the medications are more critical; consequently, the margin for error is small.
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From page 157... ...
The document describes "a recommended human factors engineering process for use in fulfilling user interface design requirements in the development of medical devices and systems, including hardware, software, and documentation." The standard includes an overview and a discussion of the benefits of human factors engineering, a review of the human factors engineering process and its analysis and design techniques, and a discussion of implementation issues. One of the most important international standards is ISO/IEC 62366:2007, Medical Deices -- Application of Usability Engineering to Medical Deices, which refers to and builds on HE74.
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From page 158... ...
To complement national and international standards, guidance associated with the concept of universal design provides useful information related to the needs of lay users. Universal design considers the needs of the broad spectrum of potential design users, which is relevant when designing medical devices (Story, 2007)
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Below are examples of how the principles can be applied to medical devices for home health care. • Principle 1.
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3c. Accommodate a wide range of literacy and language skills.
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These universal design principles can help improve accessibility and usability (and safety) for laypeople who operate medical devices in the home.
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From page 162... ...
User confusion can lead to use errors or product abandonment, either of which compromises quality of care. All home caregivers, whether professional or lay, must be adequately trained to use and maintain the medical devices that they will use in the home.
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From page 163... ...
. Medical devices may be used under variable conditions involving such environmental attributes as space, lighting, noise levels, and activity: • Rooms may be physically crowded or cluttered, making it diffi cult for the person providing or receiving care to maneuver in the space.
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From page 164... ...
. Some care recipients cannot survive long without the medical devices on which they depend.
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From page 165... ...
. In a study of telemonitoring and 19 elder home health care recipients, a few participants were unable to measure their own weight using a scale, most often because they needed help to accomplish the task and no one was available at the time; at least one-third of participants could not reliably interpret their blood pressure results as being normal or abnormal, and for a significant percentage of those, even periodic retraining didn't help (Daryle Gardner-Bonneau, Bonneau and Associates, personal communication, 2009)
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From page 166... ...
They need to establish permanent human factors departments or identify and contract with qualified human factors consultants to perform the human factors analyses needed to ensure that medical devices will be safe and usable, reducing the likelihood of product misuse or abandonment. HuMAN FACTORS ASSESSMENT The Food and Drug Administration requires medical device manufacturers to demonstrate that they have addressed human factors issues during the product's development process.
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From page 167... ...
FuTuRE DIRECTIONS FOR THE FIELD Critical gaps exist in the understanding of human factors issues for medical devices in the domain of noninstitutional health management and care. These include user issues, device issues, and environmental issues.
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From page 168... ...
could be conducted on a single blood sample, reducing the number of samples and the amount of blood that needs to be drawn. Device issues that need to be addressed include concern for accuracy of home health care devices, especially some of the more inexpensive types designed for home use.
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From page 169... ...
The field also needs better mechanisms for home health care users to provide feedback to medical device manufacturers regarding the difficulties and hazards associated with use of devices in the home. Professional and lay caregivers and people receiving home care are rich sources of information about medical device use safety and errors, which need to be tapped.
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From page 170... ...
The medical industry needs to improve the health of the general public in the United States, and it also needs to reduce the cost of providing health care. Home health care promises to advance both of these goals.
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From page 171... ...
Home Healthcare Nurse, 2(5)
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From page 172... ...
Home Healthcare Nurse, 2(5)
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