Medical Devices in the Home
FDA's Home Use Device Initiative
An Op-Ed by Dr. Nancy J Stark
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In our lifetimes, each one of us will be either a caregiver or a care-receiver. 1. Brady

It's been a year and a half since my last whitepaper. Several of you have asked why I stopped writing. My husband was diagnosed with cancer in late 2010 and my role in life quickly changed from author and business-woman to caregiver. He passed away in April 2012 as the immediate result of a shoddy medical device and a shift in business practices that uses poorly regulated specialty pharmacies as distributors.

Care-giving in the Home
When I was a care-receiver in 2000, my husband took care of me and my hospital took responsibility for my home-use IV therapy. Over six weeks of treatment, that Abbott IV system never failed once. 2. Abbott When I was the caregiver for my husband in 2012, his Curlin 4000 CMS IV system failed every 6-8 hours around the clock. 3. Moog Curlin

An incredible burden is placed on family caregivers today. We are given a burden that goes far beyond basic assisted living duties of bathing, cooking, cleaning, shopping, changing diapers, and routine errands. Today the family caregiver is expected to operate sophisticated medical equipment, recognize the signs of disease progression, treatment failure, and make critical patient assessments, all without adequate training or skills or support. I believe the device industry must take proactive responsibility to ease this burden and protect its reputation.

The American Medical Association tells us that 16% of caregivers report their own health worsening since taking on the caregiver role (mine did); 40% incur financial expenses for (non tax-deductable) care related products, services, and activities (I did); and 20% spend up to 10% of their monthly income on caregiving activities. 4. AMA Some lose their jobs when long-term leave expires. Loss of health-care coverage can follow soon after. In my own situation I was forced to stop working for two years; I supported my family and paid insurance premiums with our life savings.

Division of Labor
On 19 March 2012 my husband was admitted to Northwestern University Hospital with a painful lump on the back of his neck. We already knew he had a type of cancer that almost never metastasized, but nevertheless we were worried. Here is Frank's photograph, goofing around in the ER using his belt to hold a hot-pack in place on the back of his neck. I'm showing you his picture so you'll know I'm talking about a real human being who played a full and critical role in my life.

Frank C Suarez

Frank C Suarez, March 2012

After a work-up the lump was diagnosed as an abscess caused by a Staph infection. Frank was started on IV and oral antibiotics and began improving immediately. After a few days of treatment we were ecstatic with hope and confidence.

And then, on March 28, he was sent home with a Curlin 4000 CMS IV pump and Curlin IV administration sets. He was to receive an additional six weeks of IV antibiotic therapy at home. We had every hope of a positive outcome and every expectation that the specialty pharmacies in charge of his health would provide quality drugs and devices to support our needs. His meds and tubings were provided by Walgreen's Infusion Therapy. The pump was dispensed from another firm called Greatland Home Health Services but had a Walgreens label on it. I never was clear about who the home health care nurse worked for. A 24/7 support line was provided by someone to answer any questions that might arise at home.


Curlin 4000 IV Pump by Moog Medical

At 10 PM the first night the pump started to beep incessantly. A mystery code was displayed on the screen. We couldn't shut the noise off, and there were no instructions for use. My husband was infected, feverish, tired, weak, unable to concentrate, focus, or remember the five minutes of 'training' someone had given him at the hospital. I was tired, worried, scared, untrained, and alone with someone's life in my hands.

After extended deliberation we remembered the promised 24/7 support line for the device. When we called the 1-800-number we got an answering service. The individual said they didn't know anything about IV pumps, they were just an answering service, and they would have someone call us back. Try to imagine the urgency of the situation, the loud screeching and unending noise this machine was making late at night, and our frightened helplessness and vulnerability.

Several minutes later a return caller translated the secret code as meaning we needed to change the battery. Wouldn't you expect a home medical device to be dispensed with a fresh battery?

To compound our desperation, a previous user had jammed the lid to the battery closet on so tightly that we could not get it off. My husband was weak and could barely open a can of Pepsi. I have a small frame and arthritis in my hands; I need a pair of pliers to open a bottle of Ensure. The woman on the phone said it didn't matter that we were promised 24/7 support, they were not going to send a technician out after hours to help us. Finally my husband used a hammer and screwdriver to pry off the battery lid. I said a silent prayer for revenge hoping the damned machine would be destroyed.

Wouldn't you expect a home medical device to go through a quality check before being dispensed?

Two or three times a day over the next few days we would get error messages called "down occlusions", accompanied by loud screeching beeps and a pump that didn't deliver life-saving medicine. Since there were no instructions for use, I had not been trained, and Frank was never educated about error codes, we called the 1-800-number again. The return caller told us that a down occlusion meant there was an air bubble somewhere between the pump and the bag.

The air bubble was always in the region of the pump rollers, where the tubing was placed inside the pump. The IV set was built from two lengths of PVC tubing, attached to each other by a short segment of soft silicone-like tubing—a common construction for peristaltic pumps. The soft tubing went inside the pump and over the rollers so the rollers could move the fluid forward. This seemed to be the source of the air leak. I learned to take the tubing out of the pump, massage the air bubbles backward into the bag, replace the tubing, and restart the pump cycle. I worried that if air could be drawn in from the atmosphere, what other contaminants could be drawn in?

A Final Failure
On Easter evening, 1 April 2012, my husband and I attended mass. Frank wanted to shut the pump off for the duration of the service so that screeching alarms wouldn't disturb the congregation. Because he wanted to be independent, he was the person who monitored the pump for failures.

The primary family caregiver is expected to assess the patient and make the most important medical decision of the patient's life: should they be taken to the hospital or can they make it safely through another night? Although I asked the doctors on two separate occasions to educate me about what to watch for, all I was ever told was that if Frank was in trouble he would be 'disoriented' or 'unable to concentrate'. I had visions of a cousin with dementia who ran away from home one cold winter night.

To my eternal heartbreak, Frank forgot to turn the pump back on after mass.

We discovered the pump was off about noon the next day. The clue was that it hadn't screeched at us for twelve hours. There was an air bubble 18 inches long in the tubing. I didn't know how to disconnect the tubing from a PICC line and replace it so I had no choice but to start the task of massaging the air bubble backwards into the bag. I had to fight to get a health-care nurse come out that same day.

At 4 PM the nurse arrived and calmly suggested that Frank be taken to the ER. He simply said, "He is dehydrated." I had no understanding of the significance of those words.

Finally in the ICU, the doctors told me the dehydration had caused his liver to shut down and toxins had built up in Frank's body and brain. If he survived there would be brain damage. Frank was calling out "love out, love out" and I thought he was telling me he no longer loved me. Later I realized he meant "lights out", but he couldn't grab the right noun. The doctor and I had conversations about whether or not to "put the paddles" to him'.

A few days later Frank came home to die. The next day the administration set fell off the PICC line and he started to bleed all over his clothing, blankets, and bed. The specialty pharmacy, who promised to deliver such specialized care, actually asked me to rebuild the PICC line following instructions from them over the phone!

My husband passed away on 20 April, exactly four weeks after being diagnosed with an infection. If he hadn't been sent home, if we had been given decent equipment, if we had been given picture-based instructions-for-use, if we had been given training, if the home care nurse had come daily, if the tubing hadn't failed regularly, if I had been told the signs and danger of dehydration, if, if, if... he might have lived a few weeks longer. I used to think that if you have lived for 70 years what difference can one more week make? Now I know that the last week of life may be the most intimate, the most loving, the most important, that a couple can share.

Thirty-two days after his death, many models of CURLIN IV administration sets were recalled, including the model number dispensed to my husband. Conveniently, the specialty pharmacy did not keep records of which lot numbers Frank received.

The Blameless Middle-Man—Specialty Pharmacies
We all know the story of the meningitis infections following careless quality practices at the NECC compounding pharmacy in Massachusetts. That's when we learned that FDA has limited authority for inspection and enforcement over these firms. But the issue came to my house when I wrote to Martin J Berardi, President of Moog Medical Devices Group, complaining about the quality of his products. He was sorry for my loss and lack of training, reminded me that Moog has many educational and quality programs in place, "However, in spite of all our efforts...we cannot control what happens with our information after we provide it to the agencies responsible for the use and distribution of the pump."

The statement is significant because it illustrates how specialty pharmacies are used as a screen behind which the device industry hides. Moog only makes the devices, what speciality pharmacies do with them is not Moog's problem.

In a bipartisan effort, the House introduced HR 3089, the Compounding Clarity Act, last week. The bill would subject large compounding (specialty) operations to regular inspections, fees and other requirements from the Food and Drug Administration, and would mandate FDA to write regulations for these operations. The Senate introduced similar legislation, S 959—the Pharmaceutical Compounding and Accountability Act—in May. 5. House & Senate.

FDA's Home Use Device Initiative
In 2010 FDA launched its Home Use Device Initiative. The initiative recognizes our aging population and the challenges of using medical devices that are still too complex for an untrained lay person to use safely and effectively. Furthermore, as our health care system changes, hospital stays are becoming shorter, forcing patients who still require sophisticated care to receive that care from untrained or untrainable family members. The Home Use Device Initiative aims to: 1) establish guidelines for manufacturers of home use devices, 2) develop a home use device labeling repository, 3) partner with home health accrediting bodies to support safe use, 4) enhance postmarket oversight, and 5) increase public awareness and education. 6. Home Use Initiative.

[1] Practitioner Survey on Medical Device Labeling
In 2011, a group of home care practitioners were surveyed for FDA regarding their needs and perceived shortfalls regarding labeling for devices used in the home. The practice areas included respiratory therapy, infusion therapy, and wound care.

Practitioners agreed that more pictures and diagrams; use of color, larger font size and more white space; a short and a long version of the labeling; the short version attached to the device; hardcopy and electronic copies; and better paper quality, all were improvements needed in medical device labeling.

The practitioners identified instructions for use, troubleshooting, warnings, precautions, contraindications, adverse events, manufacturer's contact information, and lot numbers/serial numbers as the most important items to be included in the labeling. Clinical trials and references were ranked as unimportant. 7. Practitioner Survey

[2] Caregiver Survey on Medical Device Labeling
Three months after my husband died I found a Patient Guide for the CURLIN 4000 IV pump, hidden carefully behind Greatland's contract stating we were responsible for any damages. The Patient Guide, originally published in June of 2005, is a copy of a copy of a copy. The guide assumes a level of user sophistication that I find laughable: "...The cursor will be on RESUME, REPEAT Rx, or NEW PROGRAM. Move the cursor to the proper selection...." In my state of stress I could barely function beyond the age of reason, let alone figure out the proper selection.

In 2012, a group of 127 caregivers were surveyed for FDA regarding their needs and perceived shortfalls regarding labeling for devices used in the home.

These people were caring for adult family members (95%), usually spouses or partners (44%), and the majority had been using their medical equipment for three or more years. The most common medical conditions were stroke, heart disease, diabetes, cancer, lung disease, Alzheimer's or dementia, post-surgery recovery, or simply old age. The most common items of medical equipment used were patient lifts, wheelchairs, blood glucose monitors, specialty hospital beds, nebulizers, respiratory equipment, and assistive equipment.

Caregivers indicated that more pictures and diagrams would be useful in the instructions, that most don't have instructions for their equipment, and that the information they need isn't always contained in the manufacturer's instructions; instead, information came from other sources such as friends. 8. Caregiver Survey

[3] FDA Accessible Medical Device Labeling Workshop
On April 29-30, 2013, FDA held a two-day workshop on Accessible Medical Device Labeling. The purpose of the workshop was to discuss the growing need for medical device labeling to be delivered in a clear, concise, and readily accessible format so that patients, caregivers, and healthcare providers could access and utilize it. In other words, the development of a labeling repository.

FDA proposed to develop a standard format and standard content for device labeling. And they proposed that a pdf copy of every version of a device's labeling be maintained in a labeling 'database' to be maintained by FDA. Care receivers often use the same device for many years, but manufacturers commonly replace older versions of labeling as new versions become available. Care receivers using older devices are unable to obtain replacement copies of labeling if the original is lost or unavailable. 9. Accessible Labeling.

[4] Draft Guidance on Design Considerations for Home Use Devices
The FDA guidance for labeling medical devices for home use, "Guidance on Medical Device Patient Labeling," was written in 2001. The technology changes of the last decade surely need to be addressed in a labeling guidance. An updated draft guidance, "Design Considerations for Devices Intended for Home Use" was published in December 2012. The guidance discusses environmental considerations (pet, children, plants, WiFi), user considerations (cognitive level, arthritis or physical limitations), device considerations (lock-out mechanisms, calibration, mechanical strength, electrical issues, electromagnetic compatibility, wireless technology, and those pesky alarm systems), human factors, labeling, and post-market considerations. 10. Draft 2012 Guidance. For the first time in my career I submitted comments on a draft guidance to FDA. 11. Stark-Suarez Comments.

AAMI Activities
The AAMI standards community is working closely with FDA to define healthcare technologies that will meet the higher demands of home use. Joint summits are being held to identify, discuss, and formulate strategic initiatives which will help ensure the safety and effectiveness of medical technologies in nonclinical settings. You may register for the next summit being held on 9-10 October 2013 by contactinging AAMI at 1-703-253-8270. Caregiver and care-receiver input is especially important to these efforts. 12. AAMI/FDA Summit.

Training is key. Adults learn in different ways: I need a picture. Some people need a demonstration. Others need the written word. All kinds of training, available on-demand, are critically important and it is the responsibility of manufacturers to make sure this happens. If specialty pharmacies aren't doing a good job representing your device, don't use them.

Delivery of training is key. People who are dealing with life and death scenarios cannot Google for instructions. The manufacturer must make certain the labeling is in front of the caregivers face, on top of the contract for service, and permanently affixed to the device.

Support is key. If a device fails at 10 PM it is unreasonable to tell the caregiver they'll just have to wait until morning for help.

Quality is key. Devices cannot fail in home. Period.

Best Regards,
Nancy J Stark, PhD
President, Clinical Device Group Inc

1. Brady,
   Mary Brady, Sr. Policy Analyst,
CDRH, or 1-301-796-608.
2. Abbott.
   Abbott Laboratories, Abbott Park, IL.
3. Moog Curlin.
   The Curlin 4000 IV pump is manufactured by Moog Medical Inc, 4314 S 670 W  Salt Lake City, UT 84123; 1-801-264-1001.
4. AMA.
5. House & Senate.
6. Home Use Initiative.
7. Practioner Survey.
8. Caregiver Survey.
9. Accessible Medical Device Labeling Workshop, April 2013.
10. Draft 2012 Guidance.
11. Stark-Suarez Comments.
12. AAMI/FDA Summit

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