Hospice Elements And Device Models Manualidades
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8Medical Devices in Home Health CareMolly Follette StoryAs the formal health care system has become increasingly stressed, patients are being released from hospitals and other health care facilities still needing care. As a consequence, both laypeople and professional caregivers are making use of a wide variety of technologies, some of them quite complex, in noninstitutional settings to manage their own health, assist others with health care, or receive assistance with health management.
These technologies provide support not only for care related to acute and chronic medical conditions but also for disease prevention and lifestyle choices.The range of medical technologies used in nonclinical environments runs the gamut in complexity from simple materials used for administering first aid to sophisticated devices used for delivering advanced medical treatment, and in size from tiny wireless devices to massive machines. 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. Consequently, many human factors challenges must be addressed to render these technologies, devices, and systems safe, usable, and effective for use in environments beyond the institution and for use by the much more varied population of users in these environments. This chapter discusses standalone medical devices used in home health care. BACKGROUNDThe Center for Devices and Radiological Health of the U.S. Food and Drug Administration (FDA) defines a medical device as “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar article that is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease” (Federal Food, Drug, and Cosmetic Act, 2005, Sec.
201 (h), 21 U.S.C. The center’s Home Health Care Committee defines a home medical device as “a device intended for use in a nonclinical or transitory environment, that is managed partly or wholly by the user, requires adequate labeling for the user, and may require training for the user by a health care professional in order to be used safely and effectively” (U.S. Food and Drug Administration, 2009b).Medical devices used in home health care need to be appropriate for the people who use them and for the environments in which they are used. The people who use medical devices may be professional or lay caregivers or the care recipients themselves. As a group, these users have diverse physical, sensory, cognitive, and emotional characteristics. The environment of use may be the home, but it may also be the workplace or another destination in the community or across the globe.
Environments vary in the quality and accessibility of utilities, the amount of space available, light and noise levels, temperature and humidity levels, and occupants, who may include children, pets, or vermin. 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 HomeThe most common types of medical devices, found in nearly every home, are used for delivering medications or first aid. Common medication administration equipment includes dosing cups for measuring medications in liquid form, such as cough medicine, and splitting devices for reducing the size and dosage of pills. First aid equipment includes thermometers (including oral, rectal, in-ear, and forehead), bandages, ace bandages, heating pads, and snakebite kits. Other types of medical devices commonly used in the home are assistive technologies and durable medical equipment.
Assistive technologies are most often either mobility aids (e.g., wheelchairs, walkers, canes, crutches) or sensory aids (e.g., glasses, hearing aids). Other common assistive technologies are prosthetic devices (e.g., artificial arms or legs) or orthotic devices (e.g., leg braces, shoe inserts). Durable medical equipment includes environmental devices, such as specialized beds, person-lifting and transferring equipment, and toileting aids.
Recently some medical devices have been produced as consumer products that enable people to manage their own health care more conveniently and independently (and inexpensively). For example, a wide variety of blood and urine testing kits are available that detect different chemicals and conditions (e.g., illegal drugs, cholesterol, pregnancy).
Hspice Reference Manual: Elements And Device Models
Various types of monitors and meters are available to measure health status indicators, such as blood pressure or blood glucose levels (for people with diabetes). Newer consumer devices include ones that measure blood coagulation (prothrombin time and international normalized ratio, PT/INR) for people taking blood thinning medications, blood oxygen levels (pulse-oximeter), and sleep apnea. Increasing Migration of Medical Devices into the HomeClimbing 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. Even complex devices, such as ventilators, infusion pumps, and dialysis machines, are being used outside the hospital or clinic, often by lay users, even though many of those devices were not designed for and were not specifically labeled for this type of use. There are few regulations that limit the practice of using these devices in the home.One of the problems associated with medical devices used in the home is that they often are not the same models as the ones used in formal health care settings. The devices may be older or of lower quality, and professionals who encounter the devices, either in the home or when patients bring them to the clinic or hospital, may not be familiar with them.
Speaking on behalf of AdvaMed, Susan Morris, vice president for government affairs for Kinetic Concepts (a wound care technology firm), said, “One of the biggest concerns of manufacturers is that legacy devices, old products that were used in the institution that may have been replaced by newer versions, are now migrating into the home because they’re available but they aren’t products that we originally designed for use in the home” (Taft, 2007). Health care professionals sometimes send people home with medical devices, but consumers sometimes give the devices to other people or resell them, for example, through the Internet on Craigslist or eBay. Devices acquired in this manner are much less likely to be appropriate for the end-user, to be properly operated or maintained, or even to come with complete instructions.Another challenge for medical device manufacturers is that the device user often is not the person who selected or purchased it. The device provider. Users of Medical Devices in the HomeThe Centers for Medicare & Medicaid Services reported that approximately 8.3 million Americans received Medicaid home care in 2004, which represents a dramatic increase over the 1.64 million who received services in 1995 (National Association for Home Care and Hospice, 2008) (see ). The growth trend is likely to continue.Users of medical devices in the home are a diverse population.
Some users are professional caregivers, such as physicians, nurses, nurse practitioners, physical and occupational therapists, social workers, and home care aides. 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. Other device users are lay caregivers, usually family members or friends of the person receiving care. Some care recipients operate devices themselves (while providing self-care).
Lay caregivers may be of any age and may have developmental or acquired disabilities, a temporary or intermittent condition, a chronic disease, or a terminal illness (see Chapters and ). Nonclinical Environments for Medical DevicesMedical devices are used in nonclinical environments that include homes, workplaces (which may or may not be in office buildings), schools, hotels, stores, places of worship, entertainment venues, and transportation systems (cars, buses, trains, airplanes, ships, etc.). Depending on the device and the procedure, people may use medical devices in a private space, such as a bedroom, office, or restroom, or in a public space, such as an airplane, theater, or park. The variety of use environments presents significant challenges for device and user safety. EMERGENT TECHNOLOGIES IN HOME HEALTH CARETelehealth—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) can be used to monitor people’s health at a distance.
High-resolution visual images and audio can be transmitted through telephone lines or broadband connections. In coming years, remote monitoring will increase dramatically and will involve more types of equip. Ment in the home; technologies such as wireless electronics and digital processing will support communication between a diverse set of devices and remote health care providers.
Some wireless devices, especially meters and monitors, will be wearable, which will make constant monitoring possible or intermittent testing more convenient.Telehealth technologies can be used to support adherence to treatment regimens, facilitate self-care, and provide patient education. Cameras and sensors can be used to track patient movements and behaviors in the home. Monitors can collect and transmit a variety of data to health care providers at a distance, eliminating the need to visit a clinic or to call in. These technologies can also provide reminders to people at home, such as to take medications, measure their blood pressure, perform physical therapy, or schedule follow-up appointments.Future technological advances will bring new devices, such as improved pacemakers, cochlear implants, and medicine delivery systems. Miniaturization of various components, including microprocessors and nanotechnology, will make possible advances to many types of medical devices used inside and outside formal health care settings. 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. User IssuesThe characteristics of individuals who use medical devices in the home are not well known by many medical device designers.
Indeed, some designers do not understand well even the needs of “average” users, and home device users often have capabilities that are far different from average. 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), or combinations of these conditions. Unintentionally making errors that could compromise the health of the person receiving care (Kaye and Crowley, 2000). This requirement has implications for medical device design, user training programs, and ongoing support. 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 long-term care facility or a nursing home.In 2005, Hancock, Pepe, and Murphy proposed a “hierarchy of ergonomics and hedonomic needs” (see ).
The purpose of the article was to suggest that once people’s needs for safety and functionality were fulfilled, designers should address the need for pleasure.This hierarchical structure could also represent the relationships among safety, accessibility, and usability. For individuals with any sort of physical, sensory, cognitive, or emotional disability, accessibility equates to functionality. The primary imperative is that home-use medical devices be safe; the secondary imperative is that they be functional (accessible) for the people who need to use them. Ideally, devices would satisfy all levels of the pyramid: they would be safe and functional, but also usable and pleasurable, and even offer customization to individual users’ needs and preferences. There is no reason why medical devices, especially those intended for personal use, cannot be satisfying to use and aesthetically pleasing, and possibly even enable users to achieve their own health and life goals. Musedo t 30 clip tuner manual dexterity. Device IssuesSome medical devices may not be safe for all users or use environments, but medical device manufacturers have a responsibility to recognize and mitigate hazards to the greatest extent possible.
In the FDA guidance document, Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management, Kaye and Crowley (2000, p.insulin infusion pump,.implantable cardioverter defibrillator,.automatic implantable cardioverter defibrillator with cardiac resynchronization,.ventricular (assist) bypass device,.mechanical walker,.implantable pacemaker pulse generator,.piston syringe,.intravascular administration set, and.continuous ventilator (facility use) (U.S. Food and Drug Administration, 2009d).Note that this list identifies the types of devices with which professionals have had greatest difficulty in the home; lay users do not have access to these reporting systems, nor do they have any good mechanism for providing this type of feedback to the FDA.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.Three of the most common use errors when administering intravenous medications via a pump are (1) dosage miscalculation, (2) transcription data entry error, and (3) titration of the wrong medication. For home use, the first two errors (both of which result in wrong dosage) are less likely if a professional sets up the pump when it first enters the home.
The third error (wrong medication) is more likely, especially if the person receiving care uses more than one type of medication. In any use scenario, the pump operator may accidently and erroneously change the rate of drug delivery.
All of these types of errors can be life-threatening.The MAUDE database contains a report of a dosing incident involving an individual who had been using an insulin pump for about 4 years. He had been using his previous pump for 2 years but had purchased a new one 3-4 months before the incident. A few hours after he arrived home one evening, he was found unconscious in his bedroom and could not be revived by paramedics. His cause of death was determined to be a severe hypoglycemic insulin reaction. The report said, “User reported having difficulties with pump outputs. No similar pump issues with older style pump” (U.S. Food and Drug Administration, 2009c).
This suggests possible usability problems with the new pump.To minimize the possibility of pump use errors, it is important that the pump clearly display the type of drug and infusion dose rate. Has built-in intelligence and self-checks (e.g., bar code recognition, reference drug libraries, dosing limits, and best-practice guidelines), or transmits data to a remote health care facility, the chance of error is reduced (B. Braun Medical, Inc., 2000; Beattie, 2005; DiConsiglio, 2005).Another example of home device user difficulty involved a home ventilator. A family member went into the patient’s room one night and discovered that the patient had died and his ventilator was not functioning.
The family member reported that no alarm had sounded and there was a problem with the ventilator’s power cord. The police officer who arrived at the house manipulated the power cord’s plug at the wall outlet, and the ventilator powered up again (Weick-Brady and Lazerow, 2006, p. 203).Medical devices used in the home should be easy for lay users to operate and have minimal requirements for calibration and maintenance. While hospitals have departments dedicated to performing these tasks, lay users should not be expected to have this level of interaction with equipment. Devices should be self-calibrating whenever possible. Maintenance should generally be limited to only the most basic, routine functions, such as simple cleaning and battery replacement. Depending on the device involved, however, some home care providers will need to sterilize components or dispose of used supplies, and the device system should be designed so that these tasks are easy to perform.
Human Factors Standards and GuidanceU.S. And international standards provide guidance to industry on the importance of and methods for applying human factors to medical device design. Standards offer companies models for including various processes in corporate operating procedures and allow them to utilize bodies of knowledge about best design practices without having to conduct their own research. Following standards enables companies to demonstrate to the FDA (and other regulatory bodies) that they have applied best practices.One of the key U.S. Standards is referred to as ANSI/AAMI HE74:2001, Human Factors Design Process for Medical Devices. Specifies a process for a manufacturer to analyze, specify, design, verify and validate usability, as it relates to safety of a medical device.
This usability engineering process assesses and mitigates risks caused by usability problems associated with correct use and use errors, i.e., normal use. It can be used to identify but does not assess or mitigate risks associated with abnormal use. If the usability engineering process detailed in this International Standard has been complied with and the acceptance criteria documented in the usability validation plan have been met, then the residual risks, as defined in ISO 14971, associated with usability of a medical device are presumed to be acceptable, unless there is objective evidence to the contrary.ISO/IEC 62366 incorporates HE74 as an informative appendix (with the exception of a description of the relationship between HE74 and the FDA Quality Systems Regulation). These two documents describe human factors methods that may be applied to assess device safety and performance.A new standard, ANSI/AAMI HE75:2009, Human Factors Engineering— Design of Medical Devices, supplements these process documents with design guidelines. The recommended practice is approximately 500 pages long and is organized into 25 sections, including one explicitly on home health care. In an interview in August 2008, shortly before his retirement as the FDA’s human factors team leader, Peter Carstensen praised the document but cautioned against applying its contents without judgment (Swain, 2008, p.
HE75 is a very comprehensive handbook describing almost everything a designer needs to know. It’s a one-stop shopping text with most all the information a designer would need to design a good user interface and validate it. But it still requires intelligent interpretation. It’s like someone could write a detailed text on how to perform brain surgery, but careful study and practice will be needed to pull it off. HE75 is a very good start but it’s not a substitute for expertise in the field.HE75 is massive and may be difficult to apply for engineers and designers who are unfamiliar with human factors and do not know how to prioritize the recommendations for a particular device or how to choose among the inevitable trade-offs that must be made when guidelines conflict. Human factors engineering is an art as well as a science and must be practiced differently for every application.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), especially for home use.In 1995 a group of architects, product designers, engineers, and envi. Ronmental design researchers convened to articulate the fundamental concepts that underlie universal design. The purpose of the resulting document, called The Principles of Universal Design (see ), was to support evaluation of existing designs, inform development of new designs, and educate both designers and consumers about the characteristics of more usable products and environments (Connell et al., 1997; Story, Mueller, and Mace, 1998). Implicitly, their purpose was to integrate accessibility into as much of the built environment as possible in order to make it more usable by people of all ages and abilities or disabilities.Below are examples of how the principles can be applied to medical devices for home health care.Principle 1. Equitable Use—i.e., design for all.
Optimizing universal accessibility can increase the number of people for whom a medical device, such as a dialysis machine, is appropriate and therefore extend the option of home health care to more people.Principle 2. Flexibility in Use—i.e., design for each.
A bed control can accommodate users’ personal characteristics, abilities, and preferences if it can be operated with a variety of switches that can be activated with a variety of body parts (e.g., hand, foot, cheek).Principle 3. Simple and Intuitive Use—i.e., design for the mind. User interfaces for pumps (e.g., infusion, insulin, enteral) should be easy to understand and intuitive and logical to use.Principle 4. Perceptible Information—i.e., design for the senses. A blood coagulation (PT/INR) meter should transmit information in multiple sensory modes in order to maximize communication.
It could allow users to enlarge the size of the information on the display (for people with vision impairments) and offer voice output (for people who are blind or who understand auditory information better than visual). The voice output should have a volume control (for people with different hearing abilities) that can be turned off (for people who cannot or do not want to hear it).Principle 5. Tolerance for Error—i.e., design for error.
Having the device’s user interface request confirmation of irreversible or potentially critical operations can reduce the chance of inadvertent actions. Having devices that revert to benign settings when the operator takes no action for a period of time, or that automatically shut off in case of a power surge (such as by using a ground-fault interrupter), can reduce the level of hazard.Principle 6.
Low Physical Effort—i.e., design for limited strength and stamina. Buttons that activate in response to body heat require no force (however, they are unusable for people with limb pros. TABLE 8-2 The Principles of Universal DesignPrincipleDefinition and Guidelines Associated with Principle1. Equitable UseThe design is useful and marketable to people with diverse abilities.1a.Provide the same means of use for all users: identical whenever possible; equivalent when not.1b.Avoid segregating or stigmatizing any users.1c.Make provisions for privacy, security, and safety equally available to all users.1d.Make the design appealing to all users.2. Flexibility in UseThe design accommodates a wide range of individual preferences and abilities.2a.Provide choice in methods of use.2b.Accommodate right- or left-handed access and use.2c.Facilitate the user’s accuracy and precision.2d.Provide adaptability to the user’s pace.3.
Simple and Intuitive UseUse of the design is easy to understand, regardless of the user’s experience, knowledge, language skills, or current concentration level.3a.Eliminate unnecessary complexity.3b.Be consistent with user expectations and intuition.3c.Accommodate a wide range of literacy and language skills.3d.Arrange information consistent with its importance.3e.Provide effective prompting and feedback during and after task completion.4. Perceptible InformationThe design communicates necessary information effectively to the user, regardless of ambient conditions or the user’s sensory abilities.4a.Use different modes (pictorial, verbal, tactile) for redundant presentation of essential information.4b.Maximize “legibility” of essential information (in all sensory modes).4c.Differentiate elements in ways that can be described (i.e., make it easy to give instructions or directions).4d.Provide compatibility with a variety of techniques or devices used by people with sensory limitations.5. Tolerance for ErrorThe design minimizes hazards and the adverse consequences of accidental or unintended actions.5a.Arrange elements to minimize hazards and errors: most used elements, most accessible; hazardous elements eliminated, isolated, or shielded.5b.Provide warnings of hazards and errors.5c.Provide fail-safe features.5d.Discourage unconscious action in tasks that require vigilance.6.
Low Physical EffortThe design can be used efficiently and comfortably and with a minimum of fatigue.6a.Allow user to maintain a neutral body position.6b.Use reasonable operating forces.6c.Minimize repetitive actions.6d.Minimize sustained physical effort. PrincipleDefinition and Guidelines Associated with Principle7. Size and Space for Approach and UseAppropriate size and space is provided for approach, reach, manipulation, and use regardless of user’s body size, posture, or mobility.7a.Provide a clear line of sight to important elements for any seated or standing user.7b.Make reach to all components comfortable for any seated or standing user.7c.Accommodate variations in hand and grip size.7d.Provide adequate space for the use of assistive devices or personal assistance.SOURCE: Connell et al.
(1997).theses or cold hands). Some devices may be controlled with voice commands.Principle 7. Size and Space for Approach and Use—i.e., design for body sizes and postures. A medical device should provide clearance for people who use it. The diameter of a cylindrical handhold can be tapered to allow users to place their hands along whichever section best suits the size of their hands as well as their needs and preferences for the specific task.These universal design principles can help improve accessibility and usability (and safety) for laypeople who operate medical devices in the home. Device Labeling and User Training IssuesDevice labeling, instructions, and training can all affect the occurrence of use errors. Use errors may be categorized as either active or latent.
Active errors have immediate and potentially serious consequences, such as from an incorrect medication dose or an injection in an incorrect site. Latent errors occur on an ongoing basis and can be much more difficult to identify, such as failure to replace the code key on a blood glucose meter or placing old test strips into a vial of new strips that have a different code (Patricia Patterson, Agilis Consulting Group, personal communication, 2004).Instructions and labeling that accompany medical devices used in the home must also be designed for lay users. Too often, medical device documentation and labeling are written not for novice users but for health care professionals—that is, to the education and knowledge levels of people who know about medical technology in general and the subject device in. Poor labeling increases the likelihood that users will need to call either the doctor’s office or the device manufacturer’s customer service line, which is expensive and may not answer all the user’s questions. 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. All household residents who are capable should learn how to interact with the medical equipment. Some residents should be taught about the limits of their involvement, such as children who may be taught to get help if an alarm sounds.Home users may have multiple problems with training.
As described by Fisk and colleagues (2004, p. The training may be provided under the stressful and emotional context of being newly diagnosed with an illness. Training provided by a health care professional may be presented too quickly, using jargon, with little practice by the patient, and without adequate explanation of the difficulties that may arise if the steps are not followed properly. When users are at home attempting to use a system, they may forget the details of the steps, have no idea about what to do if the system does not operate as expected, and have no immediate access to help.Lack of ongoing training and support is a particular challenge when device users are faced with purchasing a device when the reimbursement period ends. When a device, such as oxygen therapy equipment, is used under reimbursement, the distributor or supplier usually sets it up, services and maintains it, and delivers any necessary supplies. However, at the end of the reimbursement period, patients must purchase the device if they want to continue using it, but if they do, they lose the supports that the distributor or supplier used to provide. The home user typically has not been trained to service or maintain the device and may not know what supplies they will need or where to procure them, which can lead to serious problems.Training should be provided in multiple formats, including visual and auditory information, because individuals have different capabilities, learning styles, and preferences.
Some people understand information better when it is delivered in visual format, and others understand the spoken word better. Some device users have limited education or are illiterate. Some people do not understand English well or at all.
Hands-on training is generally most effective.Patricia A. Patterson, president of Agilis Consulting Group, is an expert.
Getting information into people’s long-term memory so that they can recall it when needed—accurately and consistently—is like walking on thin ice: it’s risky, and when we’re talking medical, it’s dangerous. And it has less to do with the media (a.k.a.
Video) and more to do with the instructional design. If the user needs information to perform a task—where is that information going to be stored: in their head (long-term memory) or someplace else?
We try to opt for someplace else whenever appropriate for obvious reasons. What labeling can do is to minimize the need for memory by making it accessible to the user when and where needed—like stuck to the device, in the user interface itself, etc.In addition to clear device labeling and effective training, home caregivers need to have access to ongoing support, always by telephone but also through e-mail, on the Internet, or via telehealth connection. Ideally, some form of help should be available 24 hours a day, 365 days a year.