The U.S. Food and Drug Administration (FDA) recently held a two-day workshop to launch its External Defibrillator Improvement Initiative, which was met cautiously by attendees, and some observers think there may be a downside.
Although presenters praised the benefits of AEDs, a running theme that came through the two-day FDA event (held in December) was the issue of industry standardization, which could slow the development of new products.
Standardization isn’t always good, says John Freese, MD, chief medical director of the Fire Department of New York.
“Standardization really kills drive to have any innovation,” says Freese. “If their device is going to be just like their competitor’s, then there’s nothing new. We actually have the potential to stop progress when we’re not quite sure where the progress is going.”
The FDA shocked defibrillator makers in November by calling for two days of public sessions to address concerns regarding how the industry deals with recalls, product failures and manufacturing controls.
“I think the workshop was good. It was productive,” says Mark Adelman, a founding senior partner of Good to Be Alive, which markets AEDs for home use, adding that a lot hinges on what the FDA decides to do next.
During the session, Adelman urged the FDA to continue to play its vital role as a watchdog for patient safety, but he also cautioned about to carefully avoiding the “chilling effect” of increased regulation.
FDA officials called for the hearings after recording an 85.4% increase in medical device reports [MDRs], which are filed overwhelmingly by manufacturers.
However, Derek Smith, senior vice president at Philips Healthcare, cautioned attendees about interpreting the MDR statistics. Smith said there were multiple reasons for the increased number of MDRs, including more units in service, the parameters for what the FDA wants reported and an increased effort to file reports.
Megan Moynahan, the FDA’s senior network leader for Cardiac Electrophysiology Devices Network, told attendees there were issues with “quality system practices that appear to be at the heart of some problems that we’re seeing.”
Throughout the two-day event, multiple attendees made reference to standardizing AEDs. For example, one told the panel all cars have the gas and brake pedals in the same place, and a similar thinking would help with AEDs.
“There is an idea that is starting to form that maybe we should be moving toward a more standardized form of defibrillators,” says Moynahan, adding later that there’s a successful history of such efforts with other medical products.
Freese has some doubts.
“With medical devices, the FDA’s involvement is a given and necessary,” says Freese. “But without that innovation, we are potentially giving up on some patients down the road.”
—Richard Huff, NREMT-B
Watch What You Eat
Two research reports issued by the Centers for Disease Control and Prevention (CDC) in December show an estimated 48 million Americans become sick from food-borne illnesses each year, including 128,000 patients who required hospitalization.
That’s much lower than the 76 million figure that came out of the CDC’s latest major report on food-borne illness, which was released in 1999. However, due to differences in survey methods, the CDC cautioned that the new, more precise data doesn’t necessarily show a downward trend. (The CDC’s FoodNet data shows a 20% decrease in food-borne illnesses from certain pathogens in the past 10 years.)
According to the new reports, seven pathogens—Salmonella, Norovirus, Campylobacter, Toxoplasma, E. coli O157, Listeria and Clostridium perfringens—caused 90% of the illnesses, hospitalizations and deaths.
The CDC advises that different food-borne diseases need to be treated differently, depending on the symptoms. The most common symptoms are diarrhea and vomiting, which can lead to dehydration. So replacing lost fluids and electrolytes is important.
The CDC warns that sports drinks shouldn’t be used to treat diarrhea illnesses because they don’t correctly replace those losses. Additionally, antidiarrheal medication could make the illness worse and should be avoided if there’s a high fever or blood in stools.
Salmonella, which was at the center of the egg recall that sickened thousands of people in 2010, led the way by sending more than 19,000 people to the hospital and ultimately leading to the death of 378.
Christopher Braden, MD, director of CDC’s Division of Foodborne, Waterborne and Environmental Disease, told JEMS the new information on Salmonella concerns him the most.
“We’ve made the least inroads with Salmonella as a major pathogen,” Braden says. “I think we need to really rethink and redouble our efforts in that regard.”
Norovirus, which is less severe than Salmonella, was the cause of 58% of all food-borne illnesses, sickening an estimated 5.4 million people annually.
The work of frontline medical providers was essential in gathering the data.
“It reinforces the usefulness of the data that is obtained through our surveillance systems, which start with doctors and other care providers and laboratories reporting these illnesses to their local and state health department,” Braden says.
After patient symptoms are taken into account, the new information should help in patient treatment.
“I think this study will help them realize which of the ones are most likely to cause food-borne illnesses,” Braden says.
Project Organ Preservation
On Dec.1, New York City started a pilot program that could lead to a revolution in organ donation. Project Organ Preservation will follow up on prehospital cardiac-arrest deaths to recover kidneys for transplantation, according to Bradley Kaufman, MD, MPH, division medical director at FDNY and co-principal investigator for the program.
New York Police Department, FDNY and Bellevue Hospital are partners in the five-to six-month trial that allows for preservation and recovery of kidneys after an out-of-hospital cardiac arrest death.
Kidneys were chosen for the trial because they have the best chances of surviving the process leading to a transplant. The trial is funded for $1.5 million by the U. S. Department of Health Resources and Services Administration.
Police and EMS will monitor calls between 4 p.m. and midnight for possible cardiac arrest calls. If there’s a cardiac death in the field, a police detective will determine whether there’s any chance of foul play with the phone assistance of a deputy chief medical examiner.
The organ preservation team of two EMTs, an emergency physician and an organ donor family service specialist will arrive after that. The medical team will administer one minute of chest compressions, inject heparin, and establish an airway and IV after re-confirming the death. The donor specialist will talk to the family.
Potential donors must meet certain criteria. They must be a Manhattan resident between 18 and 60 years old, listed on the organ donor registry and have no disqualifying conditions, such as cancer or AIDS. A family member must consent to the donation in addition to the deceased being on the registry.
The donor body will be moved to the organ preservation unit, which is a vehicle outfitted with an automatic chest compression unit and transport ventilator, and then taken to Bellevue Hospital for further tests before transplantation.
Kaufman stresses that the pilot program is a test of processes. Even if they don’t manage to recover one kidney, the trial can succeed. The goal is to see how the system works. He also says if similar programs were in place all over the country, enough kidneys could be recovered to meet the needs of all patients on waiting lists.
Pro Bono> Don’t Count on Immunity
Many field providers who work for municipal agencies may think they can’t get sued because of the legal immunities afforded to local governments. That’s often not the case.
Yes, many states restrict the rights of citizens to bring a negligence action against their municipally operated EMS agency. It’s no surprise that state legislators would provide state, county and local government units with limited or “qualified” immunities against a lawsuit.
Many states also restrict the amount of damage awards that can be obtained by an injured plaintiff from negligent government agencies. This harkens back to the old “common law” principle that “the king can do no wrong” and that government agencies with limited resources should be protected from the burden of liability.
But even in states where this immunity shield from litigation is strong, government agencies can still be liable for negligence if the conduct of the agency was grossly negligent or if the conduct fit one of the exceptions for immunity.
For example, many states consider harming someone while operating an emergency vehicle one of those exceptions. These specially carved out government immunities vary significantly from state to state and don’t prevent a lawsuit from being filed in the first place. And the immunities don’t always protect the individual EMS field provider.
Case in point: A North Carolina judge recently allowed a negligence suit to proceed against a former paramedic. The case alleges the paramedic failed to treat an athlete who called for an ambulance after a strenuous workout but was later found dead by his parents after the paramedic left the scene. The paramedic allegedly obtained a signed “refusal” from the 17-year-old patient and was back at his base only 22 minutes after first arriving at the patient’s home.
The defendant paramedic argued he should be granted government immunity from liability for mistakes he made in the course of his duties. He tried to convince the court that he enjoyed immunity as a “public officer.”
In North Carolina, there’s a big difference between a public officer and a public employee. Public employees can be held personally liable for negligence. The law in North Carolina states that only “public officers” whose jobs are created by statute and who exercise sovereign power and discretion in their duties enjoy this immunity. That means higher level policy making officials are protected from a lawsuit while “rank and file” public employees are not. (That should be no surprise.) So this case against the paramedic public employee continues to move forward.
Bottom line: Remember that the “law of negligence” isn’t federal. Rather, it’s governed by state law. Know the law in the state where you function. In many states, EMS providers who work for private, profit or even non-profit organizations aren’t afforded the same protections from lawsuit that government employees may have. And the North Carolina case points out that even if you are a government employee, you can still be sued for negligence.
Treat people with compassion and competence, follow your protocols and use common sense. Leaving a patient at the scene after that patient called for help is one of the biggest risk areas we face.
Claims of negligence, wrongful death and abandonment are resulting in increasingly high damage awards. These cases involve patients who had the tragic misfortune to have died shortly after the hand of an EMS provider touched them, and surviving family members and juries understandably have a difficult time with that. It’s a misfortune we should all strive to avoid.
Pro Bono is written by attorneys Doug Wolfberg and Steve Wirth of Page, Wolfberg & Wirth LLC, a national EMS-industry law firm. Visit the firm’s Web site at www.pwwemslaw.com for more EMS law information.
N.Y. Drivers to Foot the Bill for MVCs?
New York City Fire Commissioner Salavatore J. Cassano recently proposed a new tax that will charge New Yorkers a car accident response fee from $365–490, depending on the severity of the accident. The Fire Department of New York (FDNY) estimates this new tax can generate $1 million annually, helping close a large budget deficit.
Cassano stated that other cities, including Buffalo (N.Y.), Dallas and San Francisco already employ similar taxes on fire department response services.
Steve Ritea, a spokesperson for FDNY, says the purpose of the crash tax is to “relieve pressure on the taxpayer and place it on those at fault and their insurance.” The motorist who receives these services will be billed, whether they were at fault.
However, with a $64 million budget, council members are opposed to charging citizens. At the budget hearing, city councilman Vincent Ignizio urged his colleagues to support a bill introduced this week that would forbid the city from charging a fee for any fire services.
FDNY officials expect that citizens will pass the accident bill to their insurance agency. Unfortunately, some insurance companies are already stating they won’t cover these charges, and if they do, insurance premiums are expected to rise.
FDNY will also have discretion over who they should bill if the accident doesn’t require medical attention, if there isn’t a fire or if the accident is caused by an external factor not perceivable to the patient.
A public hearing on the new charges was scheduled for Jan. 14. The “accident tax” would then go into effect on July 1.
Are Opioids Harming Your Patients?
A new study published in the Archives of Internal Medicine found that such opioids as Oxycodone, Oxycontin and Hydrocodone increase the risk of fractures, heart attack and all-cause mortality in elderly patients.
The study examined Medicare patients with arthritis over a six-year period who took either opioids, nonselective nonsteroidal anti-inflammatory drugs (e.g., ibuprofen) and COX-2 inhibitors (e.g., Celebrex and Vioxx).
The author of the study, Daniel Solomon, MD, says that in recent years, opioid use has risen because of concerns with long-term use of such drugs as ibuprofen and COX-2 inhibitors that cause gastrointestinal problems and heart risks. Unfortunately, more research is needed to be able to tell exactly what pain medication is best and safest for any given patient.
Although opioids were found to be less safe, it still isn’t clear why they increase the risk of fractures and heart attacks.
Solomon explains that the opioids may affect bone mass, and the drugs could be contributing to falling because it causes wooziness. The authors called the relation between the drugs and heart attacks an “unexpected finding.”
Little is known about why opioids are causing a higher health risk. Solomon thinks this shouldn’t discourage doctors from prescribing opioids; rather, it should encourage them to do so in an informed manner.
Improve Your CPR Skills
Upgrade your CPR skills from good to excellent with a new, free educational resource from the CPR Working Group, Inc. The Improve CPR toolkit, complete with a CD and DVD, includes a question and answer session with field experts, research presentations and podcasts of sessions presented at the 2010 American Heart Association Annual Meeting. It also contains interviews with CPR scientist Vinay M. Nadkarni, MD, and personal stories from survivors and providers.
In addition, the toolkit features the December 2010 JEMS supplement, “CPR Performance Counts,” which highlights the new guidelines in detail. For more information or to check out the toolkit, visit www.improvecpr.com/toolkit. Read the supplement at www.jems.com/special/cpr-december-2010.
This article originally appeared in February 2011 JEMS as “The AED Debate: Providers debate industry standardization.”