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5 Health Care Technologies in the Home
Pages 103-140

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From page 103...
... In effect, health care requires the use of technology, both by formal and informal caregivers and by care recipients. Much of the medical equipment now used in homes was designed by device manufacturers to be used only in clinical settings and by trained health care professionals (U.S.
From page 104...
... These developments also pose a challenge to the medical device industry, which must take into account these factors when designing medical technology which may be used in the home. Technology relevant to health care can be separated into two major categories: medical devices and health information technologies (HIT)
From page 105...
... premarket notification submission and additional scientific review to ensure device safety and effectiveness. Many of the devices in this category are invasive, such as pacemak ers, heart valves, other implantable devices, or high-risk medical devices, such as defibrillators.
From page 106...
... meter Pulse oximeter Weight scale Blood pressure monitor Apnea monitor Electrocardiogram (ECG) monitor Fetal monitor
From page 107...
... Telephone or Internet connections aAssistive technology or adaptive technology is an umbrella term. Given various definitions of the term, an assistive technology is essentially anything (e.g., item, piece of equipment, device, or system)
From page 108...
... It was once limited to the modest array of devices available over the counter or equipment obtainable from health care professionals or durable medical equipment providers, often only by prescription, but this is no longer the case. Care recipients can now purchase many medical devices, medications, assistive technologies, and health information technologies from a variety of sources via the Internet, including sources like Craigslist and eBay.
From page 109...
... Some of the medical devices, however, posed difficulties. Martin has some difficulty weighing himself with the scale provided when he is fatigued.
From page 110...
... Senders (1994) describes an error taxonomy with five categories that is useful in describing human error in medical device use: 1.
From page 111...
... In operating a device to provide treatment, users might make errors due to missing a step in a procedure, inserting or substituting a step, or repeating a step they already executed because they were distracted. It is easy to see why the number of errors as well as the severity of their consequences might be greater for untrained caregivers and care recipients operating medical devices.
From page 112...
... Until the FDA's recent introduction of new mechanisms for adverse event reporting (e.g., the HomeNet subnetwork of MedSun) , care recipients and caregivers had limited avenues by which to report problems.
From page 113...
... As a result, design of these devices is improving to the benefit of both formal and informal caregivers as well as care recipients caring for themselves. Problems remain, however, and this work continues (see, for example, Medical Device Consultants Inc., 2010)
From page 114...
... Regardless of their capabilities and levels of support, individuals using medical devices in the home should be able to use the devices safely, effectively, efficiently, and without making errors that could compromise the health of care recipients (Kaye and Crowley, 2000)
From page 115...
... They also discuss exploratory studies and usability testing methods. Representative care recipients and home caregivers should be included in any user testing that is conducted in order to assess the safety of the medical device and its use in the home.
From page 116...
... Given the number of problems identified in this study and the percentage of care recipients in this small sample who experienced the same problem, it is difficult to believe that premarket human factors usability testing would not have uncovered many of these problems, especially had adequate user testing been employed. Some, however, might have been seen only in a postmarketing study, thus the importance of continuing surveillance.
From page 117...
... Burdened with requirements of care provision and busy with other aspects of their lives, untrained users need medical devices to be as simple as possible, while still achieving treatment goals. In some cases, this may suggest that manufacturers develop different models of devices for untrained and for professional users.
From page 118...
... It is easy to see that the design of training materials for users of medical devices in the home is critical. But few care recipients and informal caregivers receive formal training on the proper use of a device.
From page 119...
... assumes the responsibility for training members of the household and for determining the best training technique for a particular individual on a specific device because good training materials are not available. A sizable body of knowledge employed in many aspects of user interface design for home health care applications (e.g., Tufte, 2001; Association for the Advancement of Medical Instrumentation, 2009)
From page 120...
... . These new information technology tools will enable the future health care system to become predictive, preemptive, and personalized to the needs of individual providers, care recipients, and caregivers to an extent not previously possible (Gibbons, 2007)
From page 121...
... To address some of these issues and to provide support for increased adoption of health information technology, in 2008 the Office of the National Coordinator for Health Information Technology requested a report entitled Defining Key Health Information Technology Terms (National Alliance for Health Information Technology, 2008) in which the term "health information technology" is used as an umbrella term for at least six types of technologies: 1.
From page 122...
... Generally speaking, with the exception of the personal health record, the health information technology tools defined above are designed for and used by medical providers (e.g., physician, nurse, allied health professional) working in a hospital, clinic, or office-based setting.
From page 123...
... In order to receive funds, which will become available in 2011, hospitals and eligible providers have to meet more than 20 benchmarks, including being able to write electronic prescriptions, provide care recipients with access to their own electronic medical records on request, provide clinical summaries for care recipients for each office visit, and send reminders to care recipients for follow-up or preventive care. In response, many vendors are augmenting their EHR applications with online care recipient portals, including personal health records.
From page 124...
... Collection of daily living data through PHRs gives both clinicians and care recipients insights for improving health care and health outcomes that are unattainable if records contain only data captured in clinical settings. Recording observations of daily living in a health record is not a new concept.
From page 125...
... . Consumer Health Informatics Increasingly, health information technology tools, applications, and devices are being produced for and used by healthy consumers, not just for individuals with suspected or diagnosed illness.
From page 126...
... Importantly, interactions between the consumer health informatics tools available to care recipients and the electronic health records that primary care providers and hospitals use raise issues that have a direct impact on health care in the home. Two of these issues are data ownership and data reliability.
From page 127...
... found that none of the 108 consumer health information websites examined satisfied all of the web accessibility requirements. In determining web accessibility, the authors constructed a measurement framework and scoring system based on specifications4 that offer checkpoints to determine content access for people with disabilities.
From page 128...
... Recent evidence suggests that nurses are very savvy when it comes to using information technology for health, and approximately three out of four U.S. nurses recommend health websites to care recipients.
From page 129...
... The FDA's postmarket surveillance system is insufficient to capture data to assist in the understanding of problems with medical devices in the home. Despite the proliferation of health information and integrated technologies for health care in the home, guidance and standardization are lacking for these new products regarding their content, format, structure, and usability, especially for untrained users (Karsh et al., 2011)
From page 130...
... It can be used to identify but does not assess or mitigate risks associated with abnormal use." IEC 60601-1-11:2010 This standard addresses some of the issues related to electrical medical devices used in the home. Although it Requirements for Medical offers significant guidance with respect to electrical power Electrical Equipment and considerations for home use devices, as well as some guidance Medical Electrical Systems on instructions for use, remotely audible alarms (since Used in the Home untrained caregivers may not always be in close proximity to Healthcare Environment the equipment or the care recipient in the home)
From page 131...
... It focuses on improving how the system meets the needs of users in their workflows, learning, information architecture in design of the user interface, error/warning messaging, and user acceptance. It identifies the specific requirements for designing user interfaces for health care information systems in order to ensure care recipient safety and consistent use of graphical elements and interface components in health information systems.
From page 132...
... , are being leapfrogged by technical advances and, in fact, the definition of a medical device is growing fuzzier. For example, smart phone applications are available that can perform functions that were once relegated to singlepurpose medical devices, such as glucose monitoring.
From page 133...
... is a multifunctional tool that enables users to download applications that assist them in tracking important measures, such as sleep, exercise, nutrition, blood sugar, and overall wellness. Several applications currently available allow care recipients to update and view their personal health record, understand and track medication usage, communicate with their physicians, and even participate in clinical trials.
From page 134...
... Recent advances in digital TV will soon enable care recipients to have access to rich Internet applications on their television sets. These can include using video content sites to deliver training or instructional material and perhaps full two-way communications between individuals and their caregivers in different locations.
From page 135...
... plays a major role in telehealth applications and web-based applications in which individuals transmit personal health information over the Internet. However, HIPAA cannot address some of the new and emerging trends in health information technology" (National Research Council, 2010, p.
From page 136...
... . The social life of health information.
From page 137...
... . Defining key health information technology terms.
From page 138...
... . Information for health: A strategy for building a national health information infrastructure: Report and recommendations from the National Committee on Vital and Health Statistics.
From page 139...
... . Medical device home use initiative.


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