Background
With some 76 million Americans born between 1946 and 1964 heading toward retirement, emerging technologies likely will help care for this aging baby-boomer generation. Technology is already being used to help keep tens of millions of older people in assisted living situations a lot safer.
Today, telemedicine connections can bring high-resolution images and audio through not much more than a telephone line and a computer monitor. A telemedicine device installed in the home allows a nurse to complete an exam without the person ever having to leave the house.
"Telemedicine is simply a steppingstone to a more sophisticated home health-care future," says Steve Warren, Ph.D., assistant professor of electrical engineering at Kansas State University. It's a steppingstone that adds an element of reality to a caregiver’s job as a home-health nurse by allowing them to promptly see what's troubling a patient.
Su Salud en Su CASA recognizes that as information technology becomes a more robust resource for people and their health-care providers, the link to home- and self-care products will raise issues such as liability, privacy, financing, and most important, the safety and effectiveness of the products.
The National Association for Home Care in Washington, D.C., conducted several clinical trials of home-distance monitoring of blood glucose levels by computer and found improved outcomes in diabetes care. Similarly, trials of home-distance monitoring of blood pressures showed enhanced efficiency. But failure to improve outcomes of high-risk pregnancies through home-distance monitoring illustrates the difficulties in managing certain clinical applications in the home environment, and the need for further research and regulatory controls. This will require special consideration of the capabilities and limitations of people using the devices at home as well as in different types of environments.
Part 1: User Issues--A Major Concern
Given the newness of various technologies and known problems with some home-use devices, Su Salud en Su CASA is going to be skeptical of new medical technologies that are long on promise to consumers. As technological developments become more complicated, so do the requirements for their design to ensure that they can be used safely and effectively in the home.
"Human factors" is the science of interactions between people and technology, and involves designing a device with the users' abilities, limitations, and operating environments in mind. In short, the possibility of user errors (unintentional mistakes) always is of particular concern.
Medical device design problems can lead to errors when they don't consider that consumers can become easily confused using devices in the home. Distractions, such as children or other family members, variations in lighting and noise levels, and the demands of using the device exceeding the user's capabilities, all can contribute. Other problems, such as not following procedures precisely or relying on the device too heavily, also are concerns.
And, once the user becomes accustomed to a device, failing to follow maintenance and calibration procedures, taking shortcuts when a specific technique is critical, or failing to communicate with their home health-care professionals as often as they should, also could lead to trouble.
The critical question, has always been whether consumers will be able to use new medical technology without unintentionally making errors that could compromise their health.
The ability of patients to operate a medical device, for example, can depend on medical training and experience, language barriers, literacy, memory, learning ability, dexterity, vision, and hearing. Difficulties using certain devices can be caused by advanced age, medications, or the actual medical condition that requires use of a product. The focus of most of Su Salud en Su CASA's guidances will be on ensuring that users are able to safely operate and maintain the device--anything they would need to know about, such as controls, displays, software, labeling, and instructions.
Although new devices give people increasing control and a feeling of security when managing their health, users must remember to keep in regular contact with their health-care providers.
Part 2: No Mistakes
Stephen B. Kaufman, a pioneer in home-care technology from Deerfield, Ill., supports device technology that has "simple prompts" and "no possibility of mistakes." He says, "There are just too many opportunities to make bad mistakes." For this reason, the FDA has provided human factors guidance to manufacturers on device design that will reduce the likelihood of user error. This guidance document, titled "Medical Device Use Safety: Incorporating Human Factors Engineering Into Risk Management," can be found on CDRH's Web site at www.fda.gov/cdrh/humfac/1497.html (the document is also available as a PDF).
Design controls are a system of checks and balances that increase the likelihood that a device is designed, manufactured, used, and maintained properly, and that the device is appropriate for its intended use. Design controls are the part of a quality system that requires manufacturers to consider both human factors and the intended use environment during device design. The controls are intended to "build quality into the device."
Another factor contributing to the increase in user errors is the difficulty that consumers have understanding instructions provided with devices. Most are written for health-care professionals. Su Salud en Su CASA has plans to develop, plan and write the manuals for consumer use regarding the use of home-use devices. Su Salud en Su CASA will focus on consumer education and training, , and safety issues that new technologies may generate.
Part 3: A New Paradigm for Health Care
Today, what could be characterized as a return to home health care has much to do with the emergence of the Internet as a conduit of health information to patients. Those who remember huge mainframe computers can appreciate today's technology and the exponential advances in the compilation and distribution of information.
Home- and self-care devices are being projected as a high probability area for dramatic growth. This unfolding wing of modern medicine means that 21st century home- and self-care devices could soon revolutionize health-care delivery systems in the United States. And when these potential technological marvels are ready for the market, some may lead to products that we may wonder how we lived without.
SU SALUD EN SU CASA DEVICE PROFILE FOR HOME HEALTH MONITORS
The objective is to define how devices with Bluetooth™ wireless communications can use the Su Salud en Su CASA Protocol to discover the feature set, and then communicate with the a data repository which would apply preset intuitive processes for charting, notifying designated care givers, and updating respective family members with any requirements. The intent is to define how a device with Bluetooth wireless communications can support Su Salud en Su CASA services over the Bluetooth protocol.
Medical devices, products and technologies are converging to revolutionize home- and self-care health systems in the United States, making it possible for people to play a greater role in maintaining their own health.
These systems are geared toward a prevention-oriented, consumer-driven model for health care that includes innovations such as "smart devices" that can "think" for themselves, customized wearable devices, electronic patient records, and wireless Internet-linked systems--all expected to deliver convenient, user-friendly, intelligent health care in the home.
For consumers, this could mean convenience in time and travel and reduced health-care costs, and--it is hoped--result in home-care systems that teach people to monitor themselves with gizmos that give timely warnings of illness so that they can turn to their physicians early--when intervention will do the most good. For doctors, it could mean more efficient--and effective--health care driven by patients who take greater responsibility for their own health.
When your health monitor records an abnormal value, would you use a phone to call your caregiver?
The concept of a Bluetooth home health monitor is simply to regularly record a patient's cholesterol, blood pressure, glucose level, and send abnormal levels to the patient's cell phone, but also checks measurement trends and send a composite of measurements over time to a fax ,email, or intuitive database.
The Bluetooth monitor as such would give patients at risk for diabetes, cardiac complications a chance for more mobile lifestyles.
The difference between this wearable monitor and other previously developed ones that require a patient to call into an Interactive Voice Response (IVR) system is that a wireless device not only transmits information to the caregiver through Bluetooth, a wireless network used to transfer information where urban WANS are implemented or being planned, but it is also designed to bypass the need to call in readings as proposed in Phase I using a developed IVR system.
Not only would this offer the patient more mobility, but it would save the consumer time in calling in daily readings and greatly reduce any margin of error due to miss-typing over a phone system.
There are certainly substantial advantages to be had from the ability to transmit directly from the device to Su Salud en Su CASA data repository.
Phase II: Goals and Objectives
MAJOR GOALS AND OBJECTIVES: SU SALUD EN SU CASA DEVICE PROFILE FOR HOME HEALTH MONITORS
The goal is to define how devices with Bluetooth™ wireless communications can use the Su Salud en Su CASA Protocol to discover the feature set, and then communicate with the a data repository which would apply preset intuitive processes for charting, notifying designated care givers, and updating respective family members with any requirements. The intent is to define how a device with Bluetooth wireless communications can support Su Salud en Su CASA services and reduce unintentional errors and to build quality into the service of daily monitoring of health status indicators.
CURRENT STATUS
Identification of any manufacture(s) of wireless home health monitoring technologies. Preliminary research indicates there is one manufacturer that provides a wireless Telehealth Gateway with built-in Bluetooth wireless technology for the seamless and secure transmission of data from vital sign monitoring devices like blood pressure monitors, personal weight scales, SPO2, peak flow monitors etc. to a server on the Internet.
On request, manufacturer is ready to offer private labeling and customization of a Telehealth Monitor for deployment. This partnership feature is vital for Su Salud en Su CASA to focus on services specific to home health monitoring and supports our commitment to deploy current technologies for expanded use.
SPECIFIC ACTIONS & TASKS
- Determine research and development cycles for added monitoring functions such as lipid profiles, glucose, and the feasibility of data transfers from device to a health server via cell phone.
- Explore and acquire a Telehealth Gateway. Enhance system in development for the inclusion of Cholesterol (HDL&LDL) and triglycerides tracking and interpretation.
- Negotiate a service agreement with a home health agency to offer electronic home health monitoring services as a beta test facility.
- Determine the best model for cocktail of monitors based on price, integration features, robust functions, and test each modality for tracking, reporting and interpreting multiple test results.
- Establish a portfolio business case for self monitoring and reporting vs. multiple lab tests and physician visits for interpretation of glucose, cholesterol, and blood pressure readings.·
- Develop interface criteria for integrity, accuracy, update protocol and accommodation of wireless transmission
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