Kimberly Wiles, BS, RRT, CPFT
VP of Respiratory Services
Kittanning, PA 16201-1922
(724) 763-8889, ext. 5220
Fax: (724) 763-4284
Greg Spratt, BS, RRT, CPFT
Director of Clinical Marketing
3144 CR 193
Philadelphia, MO 63463
Office: (573) 439-5804
Mobile: (857) 919-2947
Angela King, RRT, Mobile Medical Maintenance, Spencerville, IN
Unlike in some other countries, there is no central database of patients who use home mechanical ventilation in the U.S. We do, however, have a database of Medical Device Reports (MDR) compiled by the Food and Drug Association (FDA). The MAUDE database (Manufacturer and User Facility Device Experience) houses medical device reports submitted to the FDA by both mandatory reporters and voluntary reporters. Mandatory reporters include device manufacturers, importers, and device user facilities. Voluntary reporters include health care professionals, family caregivers, and patients.
Defining the terms
According to the FDA, a “device user facility” is an ambulatory surgical facility, hospital, nursing home, outpatient diagnostic facility, or outpatient treatment facility that is not a physician’s office. “Outpatient treatment facility” is defined as an entity that operates for the purpose of providing nonsurgical therapeutic care on an outpatient basis or via home health care.
The FDA included home health care agencies and their device distributors in the definition of a user facility because of the serious nature of the risks posed by malfunctions of devices used in home care. Health care professionals working in home care are likely to be the first to learn of problems with critical devices such as apnea monitors, infusion pumps, and ventilators.
The Medical Device Reporting regulation 21 CFR 803 contains the specific requirements for device user facilities to report adverse events and product problems to the FDA.
Using the database
Today, respiratory therapists working in home care can easily access the MAUDE database to learn about the types of incidents that occur in the provision of home ventilator care. However, originally, there was no specific code for home care ventilators; all life-support ventilators were classified as “CBK” devices. This made searching the MAUDE database for home care incidents virtually impossible — the user had to scan each report to try to determine if the ventilator was a home care or hospital ventilator.
In 2008, the FDA created the code “NOU” specifically for tracking home care ventilators in the MDR reporting system. Going forward, the NOU code will make it easier to search for home care incidents — but the previously logged data has not been recoded.
The MDR website does advise the database user to be cautious when interpreting the data. The database should not be used to confirm with absolute certainty whether a cause-and-effect relationship exists between the incident and the device. The website emphasizes that MDR reports may be inaccurate, untimely, and biased.
A review of the home care data reveals that MDR reports in home care often describe patient incidents that were not witnessed. Family caregivers may be traumatized by the incident and are sometimes unsure of the chain of events or whether ventilator alarms did or did not sound.
Additionally, the ventilator manufacturer’s initial MDR report is often incomplete because the ventilator has not yet been returned from the patient’s home or the durable medical equipment company for testing and evaluation.
However, even with these significant limitations, the MAUDE database can be very useful to home care therapists seeking to illuminate the potential hazards they must be vigilant for in their patient population.
Editor’s Note: In Part 2 of this article, King will share some specific examples from the database related to home respiratory care.
Robert McCoy, BS, RRT, FAARC, Valley Inspired Products, Inc., Apple Valley, MN
I recently had the opportunity to present a lecture to the Taiwan Society for Respiratory Therapy (TSRT) on the transition of pulmonary patients from hospital to home. The request came due to their need to control costs by treating chronic respiratory patients in a less expensive environment. The U.S. has a well-established home care model that the TSRT thought would be a good model to emulate for their development of a home program. Patrick Dunne was their first choice as speaker (and an excellent choice, at that), but Patrick could not go and he recommended me as another option. I was happy to accept.
My first question to the program committee was whether they wanted a presentation on our old model or new model. They were a little confused, so I explained that our old model is evolving and a new model is being established.
That was then, this is now
I explained to my Taiwanese colleagues that home respiratory care in the U.S. has its roots in equipment rentals that could be distributed by general rental locations (i.e., “ABC Rentals,” which also did party tents, etc.) From there, oxygen rentals evolved to new companies that provided focused medical products, and eventually, professional respiratory therapists to provide clinical services.
Unfortunately, over time payers determined that equipment, not service, was the only necessary component of home respiratory care. Reimbursement dropped to a level that only pays for equipment. Services, which are the most critical function in home respiratory care, have all but vanished in the U.S. So the current home care model in the U.S. is efficient equipment delivery with little to no services other than maintenance and supplies.
The new health care model focuses on total cost, not individual payments. In the U.S., institutional costs continue to rise and hospitals are now targeted to reduce costs. DRGs reduced hospital stays and 30-day readmission penalties discourage readmission in that time frame. With little home respiratory services and penalties for early readmissions, hospitals are now encouraged to improve home care to prevent lost revenue. New models are evolving that focus on value versus volume in home respiratory care.
Therefore, the question to my hosts at the TSRT was, which model do you want to hear about? They chose the new model.
Components of the lecture
My lecture included the basis and evolution of home respiratory equipment with the not well known variability of equipment performance, which can affect understanding of outcomes in patient care. If a clinician does not know how equipment performs (or doesn’t perform) that clinician may think a patient’s lack of response to a device is due to disease limitations rather than the device.
The next portion of the lecture focused on monitoring a patient for results. The goal of any therapy is to improve the patient’s lung function. Medications should lead to measurable improvement in function or maintenance of the current status. Oxygen therapy should improve and maintain oxygen levels with all activities. The ultimate goal of home respiratory therapy is to allow the patient to return to a level of performance that allows for a more normal life. Activity and exercise are critical to good health and the therapies prescribed should bring the patient back to the highest performance level possible for his disease and progression of the disease.
The presentation then focused on the respiratory therapist’s skills and capabilities, which are critical to accomplishing the above objectives in the home. A knowledgeable therapist using critical thinking skills can assess the environment, educate the patient on her disease, and identify the correct devices and appropriate drugs and therapy. The therapist will monitor for effectiveness either directly or with remote monitoring and advise the physician on patient status and need for changes in prescribed therapy. The therapist will continue to coach the patient to modify or improve behavior to prevent complications and encourage a healthy lifestyle.
I concluded the lecture by encouraging my hosts to focus on effective therapy using both products and services to keep patients outside the hospital for as long as possible and prevent exacerbations. I told them the future is bright for seamless respiratory care, both inside and outside of the hospital anywhere in the world.
This same lecture has been given at AARC meetings, yet we are still in a mode where home respiratory care is considered DME. There is a need for professional respiratory services, uncoupled from hardware, to evolve and become readily available for home care services in the U.S.
It is interesting that politics and payment are highly variable around the world, yet lung disease and the appropriate treatment of the disease are common in any county. Focusing on efficient treatment of disease and prevention is the most cost effective method of care, yet hospitalization has been the method of care for decades.
Luckily, governments and payers are now realizing this problem and challenging the medical profession to find solutions. All countries in the world, including the U.S., will need to address the traditional institutional care model with new and innovative programs that provide both advanced and basic care in the patient’s home. Again, the future for respiratory care in the home is bright and time and attention need to be channeled to this objective.
Let’s recapture our youth
Another interesting thing I observed while at the TSRT meeting was how young and enthusiastic the therapists were who attended. It appears that respiratory care is a young profession in Taiwan, and the excitement at that meeting reminded me of when I started in respiratory care in the mid-1970s. Leading therapists then were very young and idealistic, with the typical “I can do anything” attitude.
This enthusiasm created and developed the field of respiratory care. The new and emerging field of professional respiratory services in the home is the next great opportunity for the “young Turks” in the respiratory profession. It is new and exciting and is going to require therapists who can think “outside the box” — with the box being the hospital. There are many reasons why it will be difficult to create the new home respiratory care model, with reimbursement being the major obstacle, yet both quality patient care and lower overall costs are worth the effort to build the program.
Home is the best place to be
I stopped in Japan on the way home and discovered that they, too, are working on home respiratory services with improved technology and telemedicine. They don’t have respiratory therapists, yet I’m sure in the future, when we prove the value of our respiratory services with measureable outcomes, they will consider moving toward home respiratory therapists.
“Respiratory care anywhere” seems like a logical approach to medicine, as there is not a cure for patients with chronic disease, only the optimization of their condition. The best place to live a life with chronic disease is in the home; all we need is open minds, education, skills, and a can-do attitude. The time is now for this to happen.
Recruit a new member: Know an AARC member who could benefit from section membership? Direct them to section sign-up. It’s the easiest way to add section membership to their overall membership package.
Bulletin deadlines: Winter Issue: December 1; Spring Issue: March 1; Summer Issue: June 1; Fall Issue: September 1.