This report originally appeared in the December 2010 issue of DOTmed Business News

The shock and surprise experienced by bystanders as someone goes into sudden cardiac arrest only makes it harder to administer cardiopulmonary resuscitation. But manufacturers have taken the shock factor into consideration when they developed the newest technology in automated external defibrillators. The technology offers not only audible prompts, but visual display screens and videos that walk a rescuer through the CPR and resuscitation process step by step.

"[Video] overcomes the issues of comprehension and processing during a very stressful time," says Dr. Glenn Laub, co-founder and CEO of Defibtech, a defibrillator OEM. "If someone talks to you while you're trying to save a life, it can be extremely stressful."

Defibrillators are lifesavers when it comes to SCA - the leading cause of death in the United States, accounting for 325,000 deaths every year, according to the Heart Rhythm Foundation.

"To date, nothing can restart a stopped heart except an electric shock. When a person suffers SCA, for each minute that passes without defibrillation, [his or her] chance of survival decreases by 7 to 10 percent," according to the website for the American Heart Association.

Industry professionals say one of the biggest challenges in the defibrillator industry is trying to make the public aware of how deadly SCA can be and how defibrillators are crucial to saving lives.

In order to address the small window of time - three to five minutes - in which a person can be saved from SCA, these technologies deliver step-by-step instructions and feedback - whether a person is compressing too softly or slowly - for AEDs.

"The technology has gotten easier to use," says Ben Wellons, president and co-founder of eMed America Inc., a distributer of new and refurbished defibrillators. "There is CPR coaching tied in with defibrillators now."

Personal instructor
What seems to be the most common trend in the defibrillator industry is the push to make the devices more accessible to a broader group.

"Defibrillators are becoming more and more user-friendly," says Jarrod Handley, a sales associate for Tennessee-based Dixie Medical Inc. "That's the ultimate goal for every manufacturer."

More than 10 years ago, Zoll Medical Corporation introduced the visual display screen to the AED market. The device had both audible and visual prompts.

"We've led the market in many ways," says Ward Hamilton, the OEM's senior vice president and vice president of sales. "We were kind of like the ugly duckling when we came out with [the visual screen] in 1999, but now, you can't talk to anybody about defibrillators unless it's about how it helps do CPR."

Most important, experts say, is that the technology gives real-time instructions. In Zoll's devices, each session is recorded to allow people to look back on how they did and what needs improvement.

But Connecticut-based Defibtech has taken the visual screen to new levels. Earlier this year, the company released the first and, to date, only defibrillator with video instructions: the Lifeline View.

"A picture is worth a thousand words, and video is worth even more," says Defibtech's Laub.

Unlike a visual screen, which indicates what to do with pictures, Defibtech's screen shows a real-time, full-motion instructional video.

Industry experts are confident that the lifesaving devices will move toward video in the years to come.

"[Video] is going to become, within a few years, the standard of care," says Laub, pointing out that anyone, regardless of what language she or he speaks, could perform CPR using an AED with an instructional video.

Laub says in the next year his company will be releasing two to three new models. He could not elaborate on the new features or expected availability, other than to say the company intends to make the devices more durable and longer-lasting.

Still, companies have obstacles to overcome.

Lifesaver-in-training
"The biggest challenge is awareness and getting the word out about this incredible therapy and how it saves peoples' lives," says Jamie Froman, director of marketing for Philips HeartStart's AED business. "We've made incredible strides, but we always have that next challenge of making sure we can educate people about how they can meet that next survivor."

The staff at eMed recognizes owning an AED is only half the battle in saving a life. Without proper training, there is only so much one can do - even with AED audio and visual instructions - which is why the company offers education programs to its customers.

"Our role, in a nutshell, is to educate individuals on the risk of SCA and provide a solution to them that saves lives," says Wellons.

EMed targets its training program to a select handful of individuals in a facility who will ultimately become an emergency response team.

"Training, a lot of times, is outsourced or [there isn't any] at all," says Wellons. "We believe it's a key component to preparing our customers to really be ready to save a life. If you own [a defibrillator] but don't have people trained to use it or don't know where it is when that emergency happens, it's only so good."

Wellons points out that his company has saved an average of five lives per year through its training and AEDs.

Philips' Froman notes a trend in training programs, especially among the nation's police force.

"[The police] are an incredible source of potential AED rescuers," says Froman. "They are often the ones first on the scene of an emergency."

He highlights the Rochester, Minn. Police Department, which has implemented an effective AED program.

"I've had three defibrillator saves, and I obviously look at it incredibly different right now because had we not had these defibrillators and had not been trained with them, I wouldn't have that feeling of actually being an integral part of saving someone's life," said Rochester Police Department's Sgt. Craig Anderson in a video about the program.

But in addition to owning an AED and knowing how to use it, a life can only be saved if a defibrillator is used in time. Those in the industry stress the importance of having enough defibrillators in a facility so one is never more than five minutes away.

"If we can't meet that [time frame] we know we can't save a life properly," says eMed's Wellons. "If [it took us] six minutes, an individual is going to be dead."

AED at home
In addition to defibrillator technology becoming easier to use - an independent study found that sixth graders successfully and quickly used a Philips HeartStart defibrillator - it is also becoming less bulky.

Without the bulk, experts say, the devices are less intimidating for the laypeople likely to use a defibrillator in an out-of-hospital setting. That's a design aspect Heart Sine Technologies took into consideration. Not yet available in the United States, the company has created an AED for at-home use.

"It's smaller and more mobile. It's easier to use. It's designed specifically for the layperson," says Wellons, whose company will distribute the new device when it becomes available in the United States.

Heart Sine Technologies' global marketing manager Marc Lawrence expects the device to be available in the U.S. next year.

In order to purchase the at-home AED, patients are required to have a prescription. The device is currently available in Europe for about $500.

"It's very, very innovative," says Lawrence. "The design is intuitive. The user interface is intuitive. It's non-threatening. And the packaging and price point are where individuals who are at home...really need them."

Patients who have existing cardiovascular or coronary heart disease may qualify for an at-home defibrillator prescription. In some cases, severe diabetics may also be able to get a prescription.

"The primary advantage [to the home unit] is the immediate access to a life-saving device," says Lawrence.

He also points out that there's likely a population of people who would want the device just in case.

Some people see the device "as a precautionary device," he says. "They would rather have the device and not need it than need it and not have it."

Growing trends: AED accessories
In addition to the play-by-play instructions and the visual and video screens, the defibrillator industry is beginning to dabble in two emerging treatment options.

Researchers are uncovering more evidence to support the use of therapeutic hypothermia for cardiac arrest survivors.

"A number of animal and clinical studies have supported the use of this treatment, and international guidelines have been published regarding the use of this exciting new modality," according to the University of Pennsylvania's School of Medicine's website.

Earlier this year, Philips HeartStart introduced its InnerCool RTx Endovascular System, which allows a physician to cool down a patient to increase the chance for survival.

"There are emerging studies that support the benefits of temperature management for patients who survive out-of-hospital sudden cardiac arrest," says Philips' Froman.

In fact, AHA's 2005 guidelines on CPR and resuscitation supported clinical use of therapeutic hypothermia.

The new 2010 guidelines on therapeutic hypothermia have been updated for adult victims of cardiac arrest to include those who remain comatose following asystole - cardiac standstill with no cardiac output and no ventricular depolarization - as well as ventricular fibrillation, says Dr. Monica Kleinman, incoming chair of the AHA's Emergency Cardiovascular Care Committee.

"There is also increased emphasis on using therapeutic hypothermia as one component of an organized system of post-cardiac arrest care," she says.

"Therapeutic hypothermia improves survival even more," says Dr. Douglas Zipes, a past president of the American College of Cardiology.

Cam Pollock, Physio-Control's vice president of global marketing, says therapeutic hypothermia is becoming part of the standard of care for SCA survivors.

"Clinically, studies show if you cool a patient down, after sudden cardiac arrest, it seems to provide a protective mechanism," he says.

"It's not something we have the technology for at the moment, but we are certainly following and watching [developments] closely," Pollock says.

Another development manufacturers are starting to make available are carbon monoxide monitors for SCA patients.

"Outside of the hospital market, we see a growing uptake on the addition of carbon monoxide [monitors] in the defibrillator," says Zoll's Hamilton. "It's attractive in the pre-hospital setting, in trying to figure out if a patient may have been exposed to carbon monoxide."

Zoll's E Series is separate technology from its AEDs, but it is used on SCA patients, in addition to others suspected of suffering from carbon monoxide poisoning.

New guidelines focus on chest compressions
Every five years since 1974, the AHA revises its guidelines on CPR and resuscitation according to the latest science-based recommendations for treating cardiovascular emergencies, especially SCA.

In 2005, the guidelines advised the AED manufacturers to seek innovative methods to decrease the amount of time chest compressions are withheld for AED operation. This is still part of the new guidelines released in late October, says Kleinman.

As of late, there has been more of a push toward laypeople administering compression-only CPR instead of the conventional CPR, which includes compressions and rescue breaths. Recent studies have indicated that compression-only CPR could lead to better outcomes in adult patients who undergo SCA outside of a hospital.

In fact, a study published in October in the Journal of the American Medical Association found that adult victims of SCA outside of a hospital were more likely to survive to hospital discharge if bystanders administered compression-only CPR.

"Anything that interrupted compressions was detrimental," lead researcher Dr. Ben Bobrow told DOTmed News in October, referring to previous studies.

The study also found that lay bystanders were more likely to administer CPR using the compression-only method than conventional CPR, although the researchers from the University of Arizona did not study the reasons why.

"The [2005] CPR guidelines require the rescuer to use mouth-to-mouth, and a person who notices someone going into sudden cardiac arrest might hesitate," says Dixie Medical's Handley. "With the new guidelines, they're doing away with mouth-to-mouth. It makes people more comfortable. Anyone can put one hand over the other, lock their elbows and press hard at a rapid pace."

Physio-Control's Pollock was confident that the new guidelines would further stress compression-only CPR. But unlike the 2005 guidelines, which forced manufacturers to change their software, he anticipated these changes wouldn't be as big.

"We tried to make our products as configurable as they can be, and we anticipated if there were changes, we [would be] ready to make them," he says.

The single biggest change, says Kleinman, is switching up the CPR sequence. Up until now, rescuers were advised to follow the ABC sequence: airway, breathing and compression. But in order to start compressions earlier, the AHA now recommends rescuers follow CAB: compressions, airway and breathing.

When it comes to AEDs and their technology and software, this new guideline can be met by changing the audible and visual instructions to coach CAB instead of ABC.

Industry professionals note that the release of new guidelines will trigger a surge in sales, likely due to increased awareness of SCA and resuscitation and potential changes to technology.

"Every year around the guidelines, the marketplace for equipment always increases the next year," says Zoll's Hamilton. "[The guidelines] are good for the industry. The guidelines are a real driver of growth."

Click here to read about FDA's External Defibrillator Improvement Initiative.

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DOTmed Registered Defibrillators Sales & Service Companies
Names in boldface are Premium Listings.

Domestic
Ben J Wellons, eMED , AR
DOTmed Certified
Dan Aeling, QualCare , CA
Ryan Davis, Davis Medical Electronics Inc , CA
DOTmed Certified
DM 100
Ramon Manalo Jr, Requests International , CA
Kenn Matayor, Jaken Medical Inc. , CA
DOTmed Certified
Thomas Wodarczak, Jet Medical Electronics, Inc. , CA
Arthur Zenian, enBio, Corp., CA
James Fowler, BioMed Techs Inc , FL
Ronald Tarr, MEDELCO , FL
Luz Olaya, Medi-Col, Equipment Export, Inc., FL
Carlos Vargas, INCAV, FL
DOTmed Certified
D. Fosco, Redfish Medical Inc. , IL
DOTmed Certified
DM 100
Ana Ortega, General Biomedical Service, Inc. , LA
Kevin Blaser, Coast to Coast Medical , MA
DM 100
Jesus Carlos, Coast to Coast Medical, Inc., MA
Bob Gaw, PRN , MA
DOTmed Certified
DM 100
John Gladstein, Medical Device Depot , MD
DOTmed Certified
Don Grimm, Bemes Inc. , MO
DOTmed Certified
DM 100
Anwar Syed, Global Medical Parts on Line , MO
Robert Ward, Innovative Service Solutions, LLC , MS
DM 100
George Fraza, DMS Topline Medical , ND
Alison Fortin, Global Inventory Management LLC , NH
DOTmed Certified
David Ogren, OMED of Nevada LLC , NV
DOTmed Certified
DM 100
Mary Field, Medsurplusonline , NY
Robert Schirano, Finger Lakes Medical Supply , NY
Abe Sokol, Absolute Medical Equipment , NY
DOTmed Certified
DM 100
Julie Gutterman, Pulse Consultants , OH
Jarrod Handley, Dixie Medical, TN
DOTmed Certified
DM 100
Patricia Richardson, Richardson Medical LLC , TN
Charles Tucker, MedSurg Equipment, LLC. , TX
DOTmed Certified
Philip Mothena, Simple Solutions, Inc. , VA
Philips Medical Systems, WA
Cam Pollock, Physio-Control, Inc. , WA
Jonathan Dobbs, Allied 100, LLC , WI
Sherwyn Simon, Intermedequip Inc. , WV

International

Bruce Raynor, Raynor Shine Ent , Canada
Jorge Morales Mello, BIOMET , Uruguay