The iPhone and iPad are changing the world of medical devices as we know it.

Thanks to their familiar interface, Web connectivity, and powerful processing capabilities, with the right app and plug-in these iOS devices can work as super smart medical devices that make sharing as easy as the push of a touchscreen button. Consumers can now access increasingly high-quality medical devices, making it easy to be more actively engaged in their own health. And home and rural care givers can benefit from the portability and versatility of iPad and iPhone based devices.

Below I’ll discuss three examples of powerful iOS medical devices I’ve found that already exist.

1) The Withings Blood Pressure Monitor

French company Withings developed this blood pressure monitor that features an app and a cuff that fits most average-sized people. Accurate data on your blood pressure can help you monitor hypertension, which can lead to serious consequences for your heart, brain and kidney. The Withings monitor can even work with an iPod Touch, and runs at $129. You can use the device to share your data with your doctor.

2) ECEM Pulse Oximeter

This device isn’t yet available to the masses, but given its utility I imagine it will be soon. It features a small clip that attaches to your fingertip. The clip beams a light through your fingertip to a receiver on the opposite side; the amount of light received is used to determine how much oxygen is saturated in your blood. Developed by the Electrical and Computer Engineering in Medicine research group together with the Pediatric Anesthesia Research Team at the University of British Columbia, it was originally created to help make anesthesia care safer in the developing world, but can also be useful to patients with heart of lung problems such as emphysema.

3) iBGStar Glucose Meter

From Sanofi-Aventis comes this glucose meter app and plug-in. The glucose meter is a well-known device to anyone with diabetes. Today, diabetics test blood sugar with needles and a clunky kit; the iBGStar offers a small add-on to the iPhone that’s said to give better, more accurate results. Plus, getting your data on your iPhone means you can share it easily, and you can get reminders on your iPhone when it’s time for another check.

For more discussion of the benefits of these iPhone and iPad based devices, plus commentary on two more devices not discussed here and commentary from an expert on medical devices, visit the Software Advice blog for the original article.

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Katie Matlack
Medical Software Analyst
Software Advice

The iPad has been heralded as a gamechanger in a number of sectors. What will its impact be in home health? Pretty significant, I think. That prediction is based on the way the device empowers home health care workers to streamline logistics, and get more done. Below, I’ve identified three concrete ways the iPad is poised be a big hit within home health below (I’ve expanded further in a longer post on my blog at Software Advice, too).  

1. It can replace costly equipment. The iPad has a ton of processing power. And developers can easily build new apps. Given those two factors, the device is impressively extensible. Think about blood pressure cuffs that can plug into an iPad, or disposable EKG electrodes that do the same. Will home caregivers soon just carry a kit of electrodes, cuffs and sensors around? I imagine that day is not far off. After all, a company called Square has already built a credit card reader add-on for an iPhone.

2. It facilitates EHR adoption in home health. Though EHRs have been available for the home health specialty for some time, it’s never been simple for home health care givers to access these programs on the go… until now. The touchscreen is intuitive and offers an efficient way for caregivers to capture hundreds of data elements. Furthermore, a growing portion of the population is already familiar with how to use an iPhone and the iOS. This could decrease the levels of apprehension home health care givers have about using a tablet device.

3. It can transform logistics. As I wrote in my original article,

Home health workers can use existing iPad apps from gas station locators and mileage counters to the built-in camera to help them save time and be more efficient. For example, caregivers could use the camera to snap photos of receipts for expenses reports. Sharing information in real time is now as easy as a home health care team using a shared calendar. Some home health software programs have scheduling features built in, too.

For more discussion on how I think the iPad will transform home health, including a discussion of how the device might be used for accountability purposes in the future, please check out my recent blog post. If you have any comments, please feel free to send me an email at katie@softwareadvice.com I’d really appreciate the feedback! Thanks for reading.

Babysitting recently, I easily became Mama Bear with Baby Bear, a delightful three year old, living in a cave under the stairs. We both felt the safety of our time together as we lay down on the floor over and over – many times – to go to sleep and wake up to Granma Bear’s breakfast of grits, bacon and fresh banana muffins.

Also recently I was told that a five year old child said “I love Julia. She makes the best pizza!”

“But,” I objected, “I didn’t make the pizza, I helped shovel pizza slices onto paper plates for hungry kids.” My informant joked, “You now know how you are remembered.” (Gee, to think that I could have made ALL those pizza pies!).

Please consider that this entire holiday season promotes the amazing cup of kindness we have shared once upon a time. “Auld Lang Syne” a Scots poem written by Robert Burns is traditionally used to celebrate and start the New Year in many English-speaking countries. In the days of “Auld lang syne” is equivalent to “Once upon a time.”  We are connected through centuries to the heart of memory, love, loss and gratitude. “For all these lives,” we say at remembrance services, “we give thanks.”

In the same spirit, the “Yes, Virginia” editorial written in 1897 is a reply to the letter from eight-year-old Virginia O’Hanlon who asked if there really was a Santa Claus. “Not believe in Santa Claus!” the editor wrote. “You might as well not believe in fairies.”

Especially grieving widows and widowers reply with a twinkle in their eyes that they may not be having a Christmas tree or other holiday rituals like usual but they are busy helping bring joy and gratitude for the holidays with Santa on this earth since ancient times.

Some elders are often cynical saying “It’s about the imagination – the importance of it. But as you get older like us, you lose your imagination along with everything else.”

But the imagination is extremely important. Another elder who is losing her eyesight and can no longer walk has to use her imagination to get by. She calls out in strong agreement, “Mine is getting stronger!”  Is yours getting stronger?  Do you still have your imagination?

By Julia Soto Lebentritt.  A published poet and producer, Julia Soto Lebentritt is author of As Long as You Sing, I’ll Dance: The bond not the burden – the blessing not the burn–out of caregiving (release date May 2012). She is a Bereavement Facilitator at the Community Hospice of Rensselaer County.

FDA-CDRH’S RESPONSE TO INDUSTRY CONCERNS

As a result of industry’s stated concerns, the FDA-CDRH has started an initiative to ease medical device innovations to address unmet public health needs and the following criteria will be considered: the device or class of them must have serious or moderate impact on health and must affect many patients and their families; the device or class of them can be improved or prevented by the development or re-design, and;  the device must not have been developed or re-designed due to government barriers.

As part of this initiative, the CDRH created a Council on Medical Device Innovation of participants from several federal agencies. Agencies represented include the National Institutes of Health (NIH), the Center for Disease Control and Prevention (HHS-CDC), the Centers for Medicare and Medicaid (HHS-CMS), the Administration for Healthcare Research and Quality (HHS-AHRQ), the Department of Defense (DoD), the Defense Advanced Research Projects Agency and the Department of Veterans Affairs (VA).

The Council is meant to identify the most important unmet public health needs; the barriers to develop or re-design medical devices, and; actions the federal government can take to reduce those barriers while assuring the safety, effectiveness and quality of medical devices. It seeks input from the medical device industry, academia, patients and consumer advocacy groups, professional trade organizations and other state and federal bodies.

“When human factors are taken into account, the industry is making a lot of changes at every stage of [the medical device marketing process] all the way through the approval step,” Johnson says. “Part of it is identifying user groups and training conditions appropriately, simulating real-world use during testing, and overall designing the product so that it is used properly. Even in the past year with the release of the FDA’s new draft guidance, manufacturers have been changing how they go about designing and testing medical devices. In many cases, these changes have been challenging, but the important thing is that the manufacturers are  changing how they are going through the process. It is a step in the right direction.”

Vladimire Herard is a freelance writer in Chicago. She was a health writer and online publication freelancer for the Guidance Channel, Longtermcare.com and States News Service for five years. For Community Development Publications, a publication chain in Silver Spring, Md., Ms. Herard wrote and edited newsletter articles about senior health and housing (Housing the Elderly Report and Aging News Alert); substance abuse prevention and treatment funding (Substance Abuse Funding Newsletter); health care financing (Inside HCFA); and food and product safety issues (Inside FDA) for four years. She has written articles about public education reform, county affairs, crime and community development for the Chicago Defender daily newspaper, the Syracuse Post-Standard and Syracuse Herald-American daily newspapers in New York state and the Pride of Syracuse monthly newspaper in New York state for five years. A print journalist for 18 years, Ms. Herard holds a master’s degree in newspaper from Syracuse University and a bachelor degree in liberal arts from Loyola University in Chicago.

NPWT, WOUND INFECTIONS, BLEEDING AND INJURY REPORTS

Among its many actions concerning different types of medical devices, the FDA-CDRH will upgrade its Medical Device Home Use Initiative to improve the use of the negative pressure wound therapy systems (NPWT) after releasing an agency safety communication Feb. 24, 2011 to warn healthcare providers, patients and caregivers about the increase in the number of instances of serious complications such as bleeding and wound infection from their use.

The communication comes as the FDA receives reports of six more deaths and 97 injuries for a total of 12 deaths and 174 injury reports since 2007 after releasing its Nov. 13, 2009 guidances titled “Preliminary Public Health Notification” and “Advice for Patients”.

With regard to death and injury reports to the FDA, wound infection took place in more than half the cases with most being linked to maintaining the dressing pieces of the wounds. As a result of the infections, patients had delayed recovery and needed wound treatment, removal of dead tissue and drainage.

Bleeding is the cause of most adverse events and was reported in 12 patients. It occurred in patients who had blood vessel grafts, wound infections, medication for blood clots, and removals of dressings of tissues. Most cases were related to shock, low blood pressure and swelling containing blood, a condition also known as hematoma. Some patients needed more surgery to stop the bleeding, transfusions, admission to the emergency room and hospitalization.

The FDA-CDRH recommends the following for health care providers:

• Choose patients carefully for NPWT contraindicated for wound types and risk factors;
• Assure that patients are monitored;
• Be on guard for life-threatening complications such as bleeding;
• Be aware of complications due to dressing changes;
• Obtain proper training, and;
• Resume NPWT as soon as a patient is transferred to the home or another care facility.

The agency recommends the following for patients and their caregivers:

• Receive adequate training from doctors, nurses or home health care aides;
• Understand the possible complications that may be linked with using the NPWT device;
• Be aware that complications take place, and dressings have to be changed;
• Get NPWT patient instructions from doctors, home healthcare providers, NPWT distributors or the maker’s website, and;
• Talk to the doctors if incapable of managing the NPWT device at home.

NPWT forms a system of care for open wounds by removing fluids and waste material, using negative wound pressure at a wound site and drawing the edges of the wound together.

The systems are made up of a vacuum pump and make a negative pressure environment within a sealed wound. They also include dressing materials to pack and seal the wound; tubing to remove fluids; and a container to collect waste materials that are suctioned out of the wound.

The agency’s Medical Device Home Use Initiative was launched in April 2010 to do the following:

• Establish guidelines for makers of home health care use devices;
• Develop a device labeling repository;
• Partner with accrediting bodies for safe use, including such technology as nanotechnology or health informatics such as electronic health records;
• Improve postmarket supervision, and;
• Boost public awareness and education.

The FDA-CDRH created a 10-month pilot program in the summer of 2010 to help “pre-market” stakeholders such as device makers submit their labeling to the agency for posting to an Internet depository. This resource will help “post-market” stakeholders such as hospitals, medical facilities, home healthcare patients and caregivers find information about the safe use of their devices.

To support its Medical Device Innovation Initiative, FDA-CDRH sought public comment through April 2011 on proposals contained a report about the subject and hosted a meeting for stakeholder feedback March 15, 2011.

The initiative also has post-market supervision through HomeNet, a subset of the FDA’s Medical Device Surveillance Network, an adverse event reporting database linking 350 healthcare entities nationally.

The intended result is that the FDA-CDRH better understands caregivers and home health care workers and their issues and addresses them. The agency will record cases in which devices meant for a healthcare facility are used at home. The FDA-CDRH has already kept an account of safety concerns pertaining to home hemodialysis and is making similar moves for wound therapy devices.

The agency is working with the Community Health Accreditation Program and the Joint Commission of Accredited Healthcare Organizations (JCAHO), which examines and accredits healthcare facilities and programs, to enforce home health agency accreditation criteria for medical device safe use.

BLOOD PRESSURE DEVICES

Another example of a category of medical device that is increasingly gaining a presence in private homes of the chronically ill and recuperating is the blood pressure device. More BP machines are making their way into home health care for such reasons as “white-coat” hypertension.

Namely, research has found that a person’s blood pressure can be high when measured in a physician’s office as a psychological or emotional reaction to the nature of conversations held with the doctor, the institutional environment or atmosphere on the part of that patient.

In the instance of “white-coat” hypertension, the accuracy of the BP reading of an office machine is compromised, researchers say. To avoid such inaccuracy, more self-monitoring of BP at home using automated devices is being used to assess BP for technical use.

Researchers say home health care BP devices are most effective in early detection and treatment of hypertension when their readings are accurate, their measurements can be replicated and senior patients and family caregivers have enough information to use them properly and safely. Before the FDA created and identified regulations for noninvasive blood pressure (NIBP) monitors and aside from the “white-coat” hypertension phenomenon, many BP monitors were discovered to be inaccurate and lacking in adequate instructions for use.

They say that the accurate measurement is essential to determine risk and to guide treatment. Researchers explain that there is increasing evidence that self-measured BP readings taken at home can often predict future cardiovascular events and are useful for monitoring the effects of hypertension treatment.

An automated home BP monitor can cost as low as $20, contains manual inflation units and may feature printers and USB ports. The monitors are regulated to have the same performance standards in home health care as they do in hospitals or other formal health care settings.

Federal agencies in the United States are not the only entities to have expressed concerns and craft policy on the development, re-design, training and proper use of BP machines.  As early as 1987, the Arlington, Va. nonprofit Association for the Advancement of Medical Instrumentation (AAMI)’s sphygmomanometer committee (SPIO), the British Hypertension Society and the European Society of Hypertension developed standards that led to an increase in the number of home use BP devices with validated accuracy.

A sphygmomanometer measures arterial pressure and reports values in millimeters of mercury through devices that do not use mercury. Like a BP machine, it operates with an inflatable cuff to restrict blood flow. It is often used with a medical stethoscope.

Specifically, the AAMI-SPIO committee standards specify safety, labeling and performance requirements designed to protect patients and family caregivers. While they need not do so, manufacturers designing and testing their products and who must meet AAMI requirements and the standards of world bodies the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) typically label their packages to indicate compliance.

Packaging for the home health care BP monitors must provide the following details: identification of the appropriate range of arm circumferences on which the enclosed cuff component of the machine can be used; the operating and storage temperature and humidity ranges; and battery use requirements.

AAMI has created a new home healthcare committee called Medical Devices and Systems in Home Care Applications to tackle key issues, which complements the FDA’s Medical Device Home Use Initiative. The standard will raise the bar for home healthcare devices for safety of construction and installation, electromagnetic isolation, and safety when in use. Already, the FDA has joined with the AAMI and the IEC to develop a general standard IEC 60601-1-11 for medical electrical equipment and medical electrical systems intended for home health care.

Johnson says that User Centric is a member of AAMI and works with the other members to advance safety in medical technology. As a member of AAMI, company consultants attend meetings and participate in discussions about standards, guidance, and best practices for the testing and development of medical devices.

“We now see medical device making efforts to comply with the guidelines created by the FDA,” he says. “We see their behavior shifting. There is more training and much greater focus is being placed on formative and summative testing to incorporate human factors into the product design process.

Additionally, the ISO-IEC regulation titled 60601 contains language that dictates other requirements for home health care equipment under IEC 60601-1-11:2010.14. In particular, IEC 80601-2-30:2009 provides guidance for major non-electrical safety issues to address problems in the pneumatic system of a special class of BP machines known as automated sphygmomanometers.

Specifically, malfunction problems in the inflation cycle of the BP machine include a high target inflation pressure for the intended population, too long an inflated period or too rapid a repetition rate for a long period of time.

Additionally, an inflated cuff of a BP machine could fail to deflate during a determination when the device is turned off or loses power. Any one of these conditions could create injury to an aging patient, which could occur undetected if the devices are used in a private home. FDA standards provide details of how the device works under single-problem conditions to alleviate the chance of a mishap involving a patient, including a senior.

The FDA rule allows for a disruption of a specific automatic mode useful for the measurement of blood pressure at home or in a doctor’s office. Recommendations for the diagnosis of hypertension include at least two determinations to be taken every minute and the average of those determinations that must be taken as the patient’s blood pressure, including a senior. The allowance is due to the increased use of home BP monitors. The period between measurements, as directed by the manufacturers, may be from several second to minutes.

As with all devices, automated sphygmomanometers must meet electromagnetic compatibility requirements. Testing instructions and toleration for error for the device are contained in one rule. Validation methods and accuracy are also in the FDA regulation.

A BP monitor will be exposed to external pressures. As a result, it must be strong enough to absorb vibration, shock, bumps and drops in daily use. The FDA standard governing this takes a private home or hospital setting into account. Testing requirements vary based on whether the BP monitor is handheld or mobile. Many are handheld devices. After testing, the device must continue to meet all safety and performance standards.

INFUSION PUMPS

Additionally, the FDA-CDRH is creating an initiative for pump manufactures, will ease device improvements and educate users to address the safety problems associated with external infusion pumps. Infusion pumps are connected to control, accuracy and precision in drug delivery in diminishing medication errors and assisting with patient care.

The pumps are medical devices used to delivery fluids such as nutrients and medications such as antibiotics, chemotherapy drugs and pain relievers into a patient’s body in limited amounts. Examples include large volume, patient-controlled analgesia (PCAs) or pain-relieving pumps, elastomeric, syringe, enteral or gastrointestinal and insulin pumps used in all health care settings and for home health care.

The FDA has found problems, potentially leading to over- or under- infusion, missed treatments or delayed therapy. To address them, the agency has drafted a guidance to infusion pump premarket notification; sent a letter to pump manufacturers April 23, 2010; held a workshop on May 25-26, 2010 on a generic pump project; held presentations in October 2010 on such subjects as leadership on the proper use of the pumps by the most influential healthcare providers, standardization of user interfaces, drug libraries and filling data gaps on incidents; and created a website to report adverse events.

Infusion pumps in a hospital setting might undergo testing or preventive maintenance annually, with the staff cleaning it between uses. As a result, a hospital BMET might see the pumps on campus once a year.

The efforts have paid off, industry leaders say. Use of the pumps has been found to improve overall health. Research states that more frequent treatments with infusion pumps decrease medications and enable patients to feel mentally sharper and to gain weight, enhancing the patients’ sense of well-being.

Continue reading Part 5 next week…

Vladimire Herard is a freelance writer in Chicago. She was a health writer and online publication freelancer for the Guidance Channel, Longtermcare.com and States News Service for five years. For Community Development Publications, a publication chain in Silver Spring, Md., Ms. Herard wrote and edited newsletter articles about senior health and housing (Housing the Elderly Report and Aging News Alert); substance abuse prevention and treatment funding (Substance Abuse Funding Newsletter); health care financing (Inside HCFA); and food and product safety issues (Inside FDA) for four years. She has written articles about public education reform, county affairs, crime and community development for the Chicago Defender daily newspaper, the Syracuse Post-Standard and Syracuse Herald-American daily newspapers in New York state and the Pride of Syracuse monthly newspaper in New York state for five years. A print journalist for 18 years, Ms. Herard holds a master’s degree in newspaper from Syracuse University and a bachelor degree in liberal arts from Loyola University in Chicago.

Some of these new guidelines make a lot of sense, with the changes we’ve already seen in the LTC industry, this just goes hand in hand with the path they are expecting us to take.  They want a stronger compliance program in our facilities and want us to adhere to our policies and procedures.

One big area is that they are mandating is a “working” compliance program that includes review of policies and procedures.  You can get ready for this now by making the policy and procedure review part of your monthly quality assurance program.  (You are doing monthly quality assurance right?  If you aren’t you really should make that change, they will most likely require it anyways.)

We have already started this in our homes; we are reviewing 4 nursing P&P each month and 3 operational P&P.  This allows the home to look at these policies make any revisions necessary and then return them to the following months meeting for signature and finalization.  Our medical director’s attend most of our monthly meetings so they are signing off on these too.  We have actually seen more deficiencies in the state’s we work in on this very issue.  With QIS coming very soon, this is a big part of this process.

Another area the mandate is looking at is the utilization of Part B resources versus Part A or state funded programs.  With financial cuts already in place for Part A stays, the expectation is that the usage of Part B will rise.  In my opinion this is a pre-emptive strike to ward off using Part B instead of Part A due to the reduction in reimbursement.  What will flag here is if the facility has a high Part B census with a relatively low Part A case load.  I know of a facility in the south where this will help their facility…they are still dealing with antiquated physician’s that still try to “bank” Part A days…therefor beneficiaries don’t get the benefit of their 100 days of eligibility.  This new rule will help that facility…those physician’s will have to justify their decision and that will help those residents get the days they are entitled to .

The OIG is focusing on 8 areas…

• Written policies and procedures;
• Compliance Committee’s;
• Training and Education;
• Effective Communication within the facility;
• Auditing and monitoring;
• Enforcing standards and following your facilities disciplinary guidelines;
• Response to violations;
• Risk Assessment.

This is a pretty big list, but hopefully most facilities already have these plans in place.  We did identify that we needed a stronger compliance committee in our facilities so we already started the Policy and Procedure review.  But, this does give us a head start on the OIG guidelines.

Again, this is expected to be released in March of 2012, but if you want more information you can go to CMS website at cms.org and type in OIG 2012 Work Plan this will take you to the information.  Full compliance as stated in the work plan must be by March 23, 2013, that date will be here before we know it and for some there will be a lot of work to do.

By Michelle Voss.  Ms. Voss is an RN with 20 years experience in Long Term Care and is the Director of Clinical Operations for Stein LTC, a Long Term Care management group, where she services facilities in 7 states across the southern United States. With expertise in not only general nursing practices, she also specializes in education, Skilled Nursing services, reimbursement and staff education and motivation to provide that higher level of care we all seek to provide.

If you are considering a new rewarding job in senior living or in senior care nursing, therapy or administration, be sure to search NSLPN.com for the latest senior care jobs available including Home Health Jobs, Hospice Jobs, Nursing Home Jobs, Independent Living Jobs, and Assisted Living Jobs.

SAVINGS FROM USE OF MEDICAL DEVICES

Thus far, the industry’s case for medical device-supported home health care is innovations within integrated delivery systems, experts say.

For instance, the Veterans Administration (VA) Care Coordination Home Telehealth (CCHT) program – which uses video technology and messaging devices to collect information about the vital signs of patients and symptoms of such illnesses as diabetes, chronic heart failure, chronic obstructive pulmonary disease (COPD), depression or post-traumatic stress disorder – has resulted in reduced costs and institutional stays.

VA-CCHT has been discovered to reduce hospital readmissions by 19 percent and the average cost of home health care to $1,600 – compared to up to $77,000 for nursing home care – by working with formal health care settings, including senior citizen long-term care settings such as nursing homes, assisted living centers, continuing care retirement communities (CCRCs), adult day care, skilled nursing facilities (SNFs) and acute rehabilitative care centers.

As another example, Community Care North Carolina has altered its home health care model to build community health networks coordinated and run by local physicians, hospitals, government health departments and departments of social services.

Its office is based in Raleigh in the state’s Office of Rural Health and Community Care and is sponsored by the Division of Medical Assistance, which serves as the state’s Medicaid agency with funding from the North Carolina Foundation for Advanced Health Programs.

As a result of its reorganization, researchers discovered that Community Care North Carolina’s model led to an estimated savings for fiscal year 2006 of $150 million to $170 million relative to what Medicaid would have spent under previous models.

In another example, Geisinger is a physician-led health care system serving 2.6 million patients in 43 counties in Pennsylvania and Wyoming. Specifically, the healthcare network provides 24-hour health care to patients in central and northeastern Pennsylvania, including Columbia, Montour, Northumberland, Snyder, Union, Luzerne, Lackawanna, Lycoming, Wyoming, eastern Schuylkill, and northern Monroe counties and surrounding areas.

Among Geisinger’s innovations, patients communicate online with doctors to submit health monitoring information, including blood glucose and blood pressure. Between 2006 and 2008, as a result of all of its efforts, the company was found to have reduced hospital readmissions by 20 percent and hospital admissions by 18 percent.

Repair of machines by healthcare systems also has been credited with efficiency and cost-cutting. As an example, experts report that the San Diego-based Rady Children’s Hospital successfully manages, repairs and tracks equipment that is used for home health care. The hospital’s turnaround time for equipment repair is an hour to a day. An outside agency took two weeks, corporate leadership reports. The program also spared $160,000 in savings, facilities and families in year one of the operation. Cutting rental companies out of the process, repair cost cuts, and decreases in lost equipment factored into the savings.

Overall, experts say, critical success factors include cost reduction while maintaining quality; accurate and relevant measures and solutions’ seamless integration; and clear federal regulation, especially about legal liability and reimbursement.

GROWTH OF HOME HEALTH DEVICE USE, PROBLEMS

The FDA-CDRH updates its medical device initiative as research shows two important discoveries: an increase in home health care with patients with chronic illness being transferred from hospitals to acute rehabilitative care to private homes; and a projected 72 million people turning over age 65 in the next 20 years.

The agency finds about 7.6 million patients receive home health care from 17,000 paid providers. As of 2007, annual costs for home health care were estimated as $57.6 billion. This does not account for caregivers who assume care responsibilities when a home health agency no longer visits patients.

Hemodialysis equipment to treat kidney failure, wound therapy, intravenous therapy devices and ventilators are among the most commonly used medical products to be found in homes nationally, including among senior patients.

Either as an outpatient or inpatient therapy process, hemodialysis uses a dialysis machine, saline solution, tubes attached to the veins of a patient’s arm, a blood pump, pressure monitors and detectors to remove waste products and free water from the blood of a patient diagnosed with and being treated for kidney failure.

Intravenous therapy, also known as IV therapy, can help correct electrolyte imbalances, deliver medications and be used for blood transfusions or fluid replacement to treat dehydration.

Impediments to growth of in-home dialysis

The portability of the devices and downsizing has enabled at home dialysis or travel with a compact machine, including among senior patients. Still, only a small percentage of patients of any age choose to dialyze at home, says the National Kidney and Urologic Diseases Information Clearinghouse in its report Kidney and Urologic Disease Statistics for the United States. In 2005, more than 91 percent of U.S. residents on dialysis were being treated in dialysis centers.

About 28,000 patients were dialyzing in a non-hospital or non-clinic setting: about 2,100 received home hemodialysis, and nearly 25,000 received continuous ambulatory and continuous cycling peritoneal dialysis, both primarily home treatments.

A less commonly used alternative to hemodialysis and a risk for infection, peritoneal dialysis is for patients with severe chronic kidney disease, using a membrane in the abdomen to convey fluids, exchanging substances from the blood and flushing out liquid every night during a patient’s sleep or throughout the day. Hemodialysis, peritoneal dialysis and kidney transplants are the three most common kidney replacement therapies used to address kidney failure.

Research finds that many home dialysis patients have been able to return to work and report that they are healthier and enjoy a higher quality of life as a result of the procedure. Being able to dialyze at home means more frequent dialysis – perhaps six times a week than the typical in-center regime of three days per week – a measure that would favor bedridden seniors.

Thus far, data on the difference between in-home versus in-center dialysis has been lacking. The Centers for Medicare and Medicaid Services (CMS) and the National Institutes of Health (NIH) are conducting two clinical trials, with results expected this year.

Challenges for family caregivers

The FDA finds that caregivers lack enough training to work the devices for their aging relatives to convalesce at home, the instructions coming with the products do not provide sufficient guidance or are too technical and the home environment may prevent the safe use of devices. Some complications lie with the senior patients or family caregivers such as visual or hearing impairment, cognitive or physical mobility challenges, illiteracy or speaking a language other than English.

More complicated factors affect what medical device experts call the “obtrusiveness” of a home healthcare information technology (IT) system. The measure of obtrusiveness is the degree to which such a system may be unwanted, including such factors as perceptions of privacy being invaded, self-image or self-consciousness, the physical space and interference with daily routines – an issue that, again, speaks to the discomfort of senior home health care patients and family caregivers.

While patients may receive training on the operation of medical devices, such as oxygen concentrators, ventilators and sleep apnea monitors, senior patients and caregivers can do little else to maintain them besides changing filters and checking the function of alarms.

Home environment problems also include a lack of consideration of users’ capabilities, electromagnetic interference, noise levels and the presence of children and pets.

Typically, the process of a formal healthcare setting transferring a device to a residential home starts when a patient receives a leased piece of equipment that has been transported from home to home. In some cases, the labeling may get lost during the trip or disappear before reaching the rental equipment company.

Many such home health care devices end up as the property of the patient and can be purchased on the Internet. In many cases, however, they are being sold without proper maintenance instructions; without proper labeling for appropriate accessories or components, and; without proper instructions for cleaning, disinfecting or calibrating.

Without a trained operator, home health care nurses, physicians who make house calls and family caregivers will use the newly-acquired equipment in an unorthodox manner. For example, a medical device meant for indoors may be used outdoors by a nurse, physician or caregiver or be exposed to liquid spills.

A trained operator would be a biomedical equipment technician (BMET). Whether the senior patient or family caregiver is using a dialysis machine, a ventilator or a home infusion device, the BMET who maintains and services home care devices from a formal healthcare setting must be available or accessible. BMETs work on the same devices that they are assigned to in their hospitals or healthcare settings. Their training to test and service hospital equipment has been transferable to outpatient equipment. With the growing use of home health care devices, the biggest challenges the BMETs face is keeping up with the volume of work.

BMETs are expected to maintain backups, spares and emergency preparation plans at their hospitals, facilities or warehouses as contingencies for family caregivers and at-home senior patients just in case pre-existing equipment malfunctions.

Caregiver advocates such as the National Family Caregivers Association say family caregivers must have a say in the development and re-design of these devices. At the outset, caregivers want medical device companies to invent or re-design simpler medical devices. Manufacturers, they say, must consider the needs and mental state of family caregivers who will be using the medical equipment.

They add that caregivers, technicians, engineers and clinicians should be approached at the start of the design process, possibly having them interact with device prototypes.

“That is something we do see in user research with medical devices: elder caregivers do tend to represent their own user group,” Johnson says. “In these cases, we work with the manufacturers to incorporate these [elder] users in the user research. If seniors are part of the intended market for use of a product, it is important that we incorporate seniors in our testing to ensure that the product has been designed for seniors as well as the rest of the target population. Some things that we need to consider for the senior population include the potential for cognitive impairments, dementia, vision impairments, hearing impairments, or reduced manual dexterity.

“The user groups we test are based completely on who the intended target market is. In other words, who the end users will be once the product is put to market. Human factors validation studies are intended to validate that the humans who will actually be using a product can do so safely and effectively, as intended by the manufacturer.”

Certain home health care devices must be resilient, industry leaders say. For example, a home ventilator attached to a motorized wheelchair may receive more shock and vibration than it would in a hospital and device designers and healthcare staff must account for this.

Most hospitals will have biomedical engineering staff on hand who can detect a problem when the home health care device user would be less capable and therefore may be more dependent on the strength and efficacy of the equipment.

To address the problem of training and technical support to family caregivers and their senior home health care patients, the FDA has added an equipment specialist to its branch offices, who, in turn, gets support from BMETs and a preventive maintenance coordinator to serve the healthcare departments representing more than 500 pieces of equipment.

Testing

Among the problems BMETs are trained to address are the clarity and usability of machine monitor surfaces. Various graphic user interface options are tested with patients and clinicians to ensure the graphics are easily understood.

Testing on the used device is mandatory after each use. As a result, BMETs will test these devices 50 to 60 times a year. By contrast, hospital staff will test a comparable device in the hospital once in the same time frame.

For example, oxygen concentrators are tested every six months, whereas some manufacturers state they can be tested annually. However, many device makers say they believe this is an excessively long time for a device to leave a hospital or health care facility without testing.

Privacy, costs of distant travel

Another challenging aspect of home health care devices is the technicians’ greater exposure to patient information. BMETs have access to patient names, phone numbers and contacts. That exposes BMETs to violating the Health Insurance Portability and Accountability Act (HIPAA) and legal actions concerning privacy that they otherwise do not encounter in a hospital or formal health care setting.

Patient protections and privacy aren’t the only issues. For clinicians such as respiratory therapists and technicians who deliver and set up equipment, the distance, travel and the personal contact within a person’s home can also pose conflicts to an agreement between hospitals or formal health care settings and a homebound senior patient and his or her family caregiver. This means greater costs and some discomfort for senior home health care patients and possibly family caregivers.

Continue reading Part 4 next week…

Vladimire Herard is a freelance writer in Chicago. She was a health writer and online publication freelancer for the Guidance Channel, Longtermcare.com and States News Service for five years. For Community Development Publications, a publication chain in Silver Spring, Md., Ms. Herard wrote and edited newsletter articles about senior health and housing (Housing the Elderly Report and Aging News Alert); substance abuse prevention and treatment funding (Substance Abuse Funding Newsletter); health care financing (Inside HCFA); and food and product safety issues (Inside FDA) for four years. She has written articles about public education reform, county affairs, crime and community development for the Chicago Defender daily newspaper, the Syracuse Post-Standard and Syracuse Herald-American daily newspapers in New York state and the Pride of Syracuse monthly newspaper in New York state for five years. A print journalist for 18 years, Ms. Herard holds a master’s degree in newspaper from Syracuse University and a bachelor degree in liberal arts from Loyola University in Chicago.

With the constant struggles to maintain staff, tougher regulatory guidance, new MDS processes, reductions in Medicare reimbursement and a new survey process already in place or coming very soon, it is no wonder nurses are leaving long term care in record numbers.

How to do you balance all this and still maintain a modicum of sanity?  That is much easier said than done, but hopefully I can give you some tips that will help preserve just a small amount of that sanity.

• Don’t sweat the small stuff…we all let the little things get to us, but, as a nurse leader you have an option.  You have to prioritize every second of your day.  Problems that endanger the safety and wellness of your residents of course come first.  But, problems with supplies or a policy that you need for next week’s staff meeting can wait.  Put them on the “do later” list.
• With that being said, don’t procrastinate…I’m probably the worst when it comes to procrastination; it’s something I have to work on each and every day.  The only way I accomplish this is to use lists.  I have lists in my planner, on my smart phone and make a list each morning, no matter where I’m at.
• Don’t set yourself up for failure!  By making that list, only put a few items on it.  Don’t put down everything you have to get done for the week, only put down what you have to get done that day.  Once you do this, add all the things you get done that aren’t on your list.  This will help you see that even though you might not have gotten each thing on your list done, you did get more things finished.  Take credit for everything you’ve done, that way you have a sense of accomplishment at the end of the day.
• Delegate, delegate, delegate.  We all have a little control-freak in us, but in order to succeed in today’s challenging times; we have to share the misery!  That task that you have a really hard time with is the one to share with your other team members.  You never know they just may absolutely thrive at this task.
• Communicate…if you are bogged down, you can’t hold all that in, the panic and guilt and long hours will only burn you out faster.  You need to let your supervisor know that you need help, you can’t continue to hold all the pressure in or you will eventually lose control.  Your supervisor probably already knows you are struggling but if you communicate with them it leaves everything open and honest.

These are just a few tips to help you, but I promise if you just try one of them, you may feel a lot better and anything we can do to survive all this is worth the effort!

If you have some tips that help you cope, I’d love to hear about them!  Please, just comment any ideas or tips to this blog and we’ll share them with the others!

By Michelle Voss.  Ms. Voss is an RN with 20 years experience in Long Term Care and is the Director of Clinical Operations for Stein LTC, a Long Term Care management group, where she services facilities in 7 states across the southern United States. With expertise in not only general nursing practices, she also specializes in education, Skilled Nursing services, reimbursement and staff education and motivation to provide that higher level of care we all seek to provide.

If you are considering a new rewarding job in senior living or in senior care nursing, therapy or administration, be sure to search NSLPN.com for the latest senior care jobs available including Home Health Jobs, Hospice Jobs, Nursing Home Jobs, Independent Living Jobs, and Assisted Living Jobs.

DEVICE INDUSTRY, CHALLENGES

Overall, through a series of workshops and presentation meetings held by the FDA in the past decade, the medical device industry has touted the rise of home health care as the most influential trend in treating chronically ill patients and cutting costs.

Home health care is part of a larger continuum of care, industry advocates argue. They say that this growing subset of the health care industry promotes quality of life, lowers costs and can collaborate with residential care and acute care.

They add that medical device development and re-design promotes public health, including the prevention, detection and treatment of serious diseases. Industry experts identify barriers to medical device innovation as a lack of market viability, a lack of standardized guidance and a punitive Medicare/Medicaid reimbursement policy.

Experts explain that market viability means implementing care in the home and mobile care as the new health models; providing industry with education in order to adapt; sharing the good news about the new model across the national healthcare spectrum; allowing research to publicize claims of reduced readmissions; allowing the claims for all devices that qualify; and encouraging clinicians to adapt new health technologies, research or workshops on new workflow models.

Experts say that a standardized guidance should result in safety, efficiency and consistency in the use of medical devices. It is not enough that the user manual going with the device is accurate, they say. The senior patients and family caregivers should be able to read the font of the labeling or instructional manual and understand its language.

Experts say that device makers consult international standards to guide design, especially the International Electrotechnical Commission’s (IEC) 60601-1-11 regulation, which focuses on requirements for medical devices and medical electrical systems used in home health care. The standard includes tests of temperature and durability for devices.

Medical device companies, they say, should be able to operate on a level-playing field by using the same definitions for different types of “post-market” stakeholders such as BMETs, senior patients, family caregivers, family practice or internal medicine physicians and medical specialists, nurses, certified nursing assistants (CNAs) and direct care workers, according to disease state, physical mobility and categories of care. Such a level-playing field would result in a standardization of validation of activities.

Additionally, it will be easier to analyze data on the use, safety and effectiveness of the medical devices, which will enhance understanding of the new market, experts say.

Support for the way in which device makers are reimbursed by Medicare and Medicaid means a better identification and comprehension of the major companies, they say. Currently, the industry uses 510(k) and PMA processes to qualify devices for reimbursement.

A clinician-customized care protocol, medications, vital sign measurements and alerts to the BMETs – when vital signs are a cause for concern – comprise a complete solution. A clinician can complicate labeling, industry leaders say. Namely, a device maker will create labeling but a clinician will change it to meet medical needs.

One-stop shopping is also a part of the Medicare/Medicaid reimbursement charge, industry advocates say. To resolve the matter of poor reimbursement, the industry says that it must share its healthcare outcome data with the White House’s Office of Management and Budget (OMB) and the Centers for Medicare and Medicaid (CMS).

Medical device industry leaders say that member companies should shorten the time it takes to bring their inventions or product improvements to market, using the 510(k) process for market clearance and the Medicare/Medicaid reimbursement codes.

Leaders also say they must champion greater Internet access for senior citizens. They argue that seniors and persons with disabilities are the least likely of any demographic in the nation to have broadband connectivity and, increasingly, this is needed as many medical devices for home health care require a connection to the Web.

Data capture must be as reliable as possible to ensure data integrity and the timeliness of information transfer, industry leaders say. In particular, Medicare and Medicaid should reimburse the costs of installation, distance of travel, and Internet access when the medical devices in question are used as part of an overall home health plan of care.

The industry also says that its member companies must form internal and external research and development partnerships to drive proof of the validity of product concepts, invention and re-design and business-model innovation. It also demands that these partners push for federal and state laws, regulations, funding and technical assistance for medical device makers. Leaders also call for advocacy and policy to enlighten and win the support of the public.

They ask that financial institutions provide risk capital to encourage early-stage innovations, especially companies producing, updating and delivering medical devices and engaging in follow-up customer service.

Device manufacturers are eying a number of federal spending scenarios, including a prediction of expenditures spanning the years 1962 to 2082. While updated figures in 2011 are pending, another prospect from the December 2007 long-term budget outlook showed the Congressional Budget Office (CBO) embracing changes in medical device policy unlike that of the past. Projected figures amounted to $20 billion for Medicare and Medicaid in 2012 and $35 billion in 2082. Additionally, under these scenarios, Social Security would contribute $10 billion in 2012 through 2082 to government policy and programming supporting the development and re-design of medical devices.

MEDICAL DEVICE-SUPPORTED HOME HEALTH CARE

In the past decade, federal research has favored the development and re-design of medical devices for home health care, including seniors in long-term care.

The U.S. Department of Health and Human Services’ Health Resources and Services Administration (HHS-HRSA) reports that 75 percent of U.S. health care occurs with home health care with medical devices, due to chronic disease complications.

HRSA explains that about 20 million Americans have diabetes and the same number have kidney failure, about 50 million have hypertension, nearly 65 million have cardiovascular disease, two-thirds are overweight and one in five is obese, thus warranting follow-up care after hospitalization.

Additionally, a National Health and Nutrition Examination Survey (NHANES) study finds that at least 65 million adult American have hypertension.

The Framingham Heart Study in Framingham, Massachusetts reports that the lifetime risk of hypertension is about 90 percent even among individuals who do not receive intensive care at ages 55 to 65 and who live to see ages 80 to 85. The Framingham program has released research for decades on several medical topics such as Alzheimer’s disease and dementia, malnutrition in seniors, mental health and hypertension and works with the National Heart, Lung and Blood Institute (NHLBI) and Boston University.

To confront the high incidence in diabetes, kidney failure, hypertension, cardiovascular disease and obesity, industry advocates say that a new model of health care can be found in infrastructure independence. The current model is very institution-intensive and, as a consequence, amounts to low frequency visits, a focus on acute care, appointments, location specificity and high costs. By contrast, the new model would translate into high touch, appropriate treatment, on-demand care, convenience, location and lower costs, advocates say.

They say that chronic illness is diagnosed by medical incident and is treated accordingly, taking up a substantial volume of resources brought about by the worsening of already-negative health conditions, budget cuts to health care and other conflicts. Experts project that chronic disease will be addressed with a continuum of care and outcomes improvement will reduce costs and avoid acute conditions.

Many plans of care, they say, are centered on technology. Industry leaders say that medical device firms must re-examine the state of their production, delivery and follow-up customer service of home health equipment and identify their fundamental problems. Most likely, they will  end up finding that solutions provide seamless delivery, quality and lower cost.

Experts say that “device-based, closed-loop, feedback-controlled therapeutics” ought to drive the willingness to “personalize” medicine and connect therapy with the desired effect, not merely avoid health complications. It should foster a growing trend for consumer-driven care; a need for care devoid of institutions, chronic and changing disease activity; and the drive to lower costs, which are caused by illness and expensive infrastructure.

Industry experts say that huge potential exists for the development and re-design for home health care medical devices, including for senior patients and family caregivers. Development and re-design of devices is emerging against the background of what experts call an untenable healthcare model to which access has been increased.

However, experts say the medical device industry faces serious legal concerns. There are patient protections for medical data or privacy, but there must also be clarity on who should incur risk and liability and the pursuit of tort reform. Current “disclarity” is keeping the private sector from investing in medical device firms, they say.

Other legal issues abound. Industry leaders agree that instructions must be simplified for caregivers and accessible. But developing easier guidances is difficult because device makers feel that they must include information and precautions to prevent legal liability.

The industry asks that the FDA clarify the distinction between medical devices that detect illness and devices that are multi-use and nonmedical. To this end, the FDA and the device industry is convening a health regulatory coalition to develop a guidance document.

Continue reading Part 3 next week…

Vladimire Herard is a freelance writer in Chicago. She was a health writer and online publication freelancer for the Guidance Channel, Longtermcare.com and States News Service for five years. For Community Development Publications, a publication chain in Silver Spring, Md., Ms. Herard wrote and edited newsletter articles about senior health and housing (Housing the Elderly Report and Aging News Alert); substance abuse prevention and treatment funding (Substance Abuse Funding Newsletter); health care financing (Inside HCFA); and food and product safety issues (Inside FDA) for four years. She has written articles about public education reform, county affairs, crime and community development for the Chicago Defender daily newspaper, the Syracuse Post-Standard and Syracuse Herald-American daily newspapers in New York state and the Pride of Syracuse monthly newspaper in New York state for five years. A print journalist for 18 years, Ms. Herard holds a master’s degree in newspaper from Syracuse University and a bachelor degree in liberal arts from Loyola University in Chicago.

Beatrice, an 88-year-old retired teacher, asked for this kind of caregiving pulling me aside one day to report an incident. She gestured with both arms cradling herself slowly rocking. “We cannot do everything for ourselves. They need to treat us gently. Talk with us and work slowly.” But what does a caregiver do with their feelings of impatience, weariness and hopelessness especially at the end of a long day?

At the heart of the matter, comparing caregivers with lullaby singers makes me recognize the ambiguities of caregiving and why caregivers need to know more about quieting and soothing themselves as well as those whom they care for. Often as the poet Yehuda Amichai wrote, the lullaby singer sings “about terrible things in a sweet voice.” Motifs in lullabies worldwide include not just angels and golden flowers.

When I came on this very old lullaby I thought of the burden of caregiving: “While close I hold thee in my arms/And sing my lullaby/I think – what could become of thee/If I should chance to die?” Here the caregiver fears her own mortality. The chance is always there that the caregiver, not the cared for, will exit first. This is the desperate caregiver’s thought because the total responsibility is the caregiver’s.

Most often folk lullabies emerge from the oral poetry of women who are feeling the weariness of a mother due to lots of labor and little rest with a crying restless baby. Loneliness; impatience; love/hate relationships, aversion and hostility; vulnerability; guilt; imagined other worlds; even potential for violence when caring for a helpless human being persists in the world’s lullaby lyrics. While ambiguities are often expressed in the lullaby and there is a lack of sentimentality sometimes, the sweet loving voice with tender kind touch can help the mother express her feelings, process and accept them without acting out negatively or hurting herself or her loved one.

So these ancient universal ways of soothing and relaxing both mother and child can help a caregiver survive what John Zeisel calls “the four A’s of Alzheimer’s – anxiety, aggression, agitation and apathy.” As professional and non-professional caregivers of the elderly, we experience constant psychological stress related to the difficulties that illness inflicts on the patient, their families and friends.

We can ease the symptoms of our own caregiver fatigue by consciously activating self-care rituals with music, visuals, visualizations (storytelling, poetry), creating comfort and a sense of home, witnessing nature, using facial expressions, touch, rhythmic drumming and finding more and more ways to help each other when things get tough.

By Julia Soto Lebentritt.  A published poet and producer, Julia Soto Lebentritt is author of As Long as You Sing, I’ll Dance: The bond not the burden – the blessing not the burn-out of caregiving . She is a Bereavement Facilitator at a Community Hospice. Contact her at lullabologist@aol.com.