This report originally appeared in the July 2011 issue of DOTmed Business News

Last April, Vanessa Seale, a 30-year-old health teacher and coach at a Texan middle school, collapsed on her school’s gym floor from sudden cardiac arrest.

Alerted by a group of students, the school nurse rushed to the gym to find Seale with no pulse. She started cardiopulmonary resuscitation and asked someone to get the automatic external defibrillator, hanging in a wall-mounted case in the hallway.

The two shocks delivered by the AED ended up snatching Seale from the jaws of death. Data collected by the defibrillator later helped a cardiologist determine that she has long QT syndrome, a heart rhythm disorder.

Thanks to the AED, Seale avoided becoming one of the nearly 300,000 Americans who die every year due to sudden cardiac arrest, according to the Sudden Cardiac Arrest Association.

After the incident, Seale told the Star-Telegram that the AED is “pretty dummy-proof,” simply requiring a rescuer to push a big button and stand clear as the shock is delivered.



The devices were once significantly more complicated and could only be used by trained medical professionals. Fortunately, the technology has come a long way. Today, an AED can be used by practically anyone and can be found anywhere from a casino to a health club.

And the simplicity of the device is key -- time is precious when administering aid to someone suffering from AED. If defibrillated within the first minute of collapse, the chances that a person will survive are close to 90 percent. For every minute that a shock isn’t delivered, the survival rate drops by 7 to 10 percent, according to the SCAA.

AEDs are quickly becoming the standard of care in the public sector, and manufacturers are making sure the devices are as user-friendly as possible. More recently, companies have also placed a bigger emphasis on the role of AEDs in the facilitation of the entire resuscitation process.

Coaching CPR
Every five years, the American Heart Association relies on the latest research to issue an updated version of its Guidelines for CPR and ECC. The most recent AHA guidelines came out in 2010.

One of the key highlights from the association’s recommendations is the strong and continuous emphasis on high-quality CPR.

In response to AHA’s renewed focus, manufacturers are touting technologies that help responders perform quality CPR.

For example, Zoll Medical Corporation utilizes the Real CPR Help technology on their devices. “It’s a system that measures the depth of chest compression when doing CPR and provides a rescuer with feedback on whether they’re doing the right depth or not,” explains Ward Hamilton, the company’s vice president of marketing.

The system includes a compression rate indicator and audio/message prompting, which provides feedback on the quality of compressions and minimizes interruptions in the CPR process. It also gathers relevant information. “A lot of data is collected on the CPR after the event to debrief the staff on how well they managed it,” Hamilton says.

Zoll pioneered the technology to enhance CPR performance back in 2002 and its Real CPR Help system now comes standard on all of the company’s defibrillators.
Another manufacturer that coaches responders through the rescue process is Defibtech. Its newest unit, the Lifeline View AED, employs video to get the job done. As the pads are placed on the victim and the ECG is read, the AED offers customizable video and audio instructions on what to do next, explains Greg Slusser, Defibtech’s vice president of sales and marketing.

“It’s not running through a DVD selection of scenes,” says Slusser. “It’s reading the ECG off the victim and then immediately determining what video instructions should be played to the lay responder on everything from where to place the pads, to how to deliver the shock and perform CPR.”

Defibrillator maker Physio-Control offers a CPR-focused product for its medical emergency response customers. This winter, Physio-Control completed the acquisition of the Swedish company Jolife AB, the maker of the Lucas Chest Compression System.

Lucas is an automated compression device that enables rescuers to deliver quality, uninterrupted compressions. The product has been popular with Physio-Control’s customers and the recent AHA guidelines updates boosted its demand, says Cam Pollock, the company’s vice president of global marketing.

The automated device not only ensures uninterrupted compressions at the rate that’s in accordance with the AHA guidelines, but also eases the rescue process for the emergency responders. “When transporting a patient who is still in arrest and requires CPR or re-arrests and requires CPR, it’s much safer for providers if they can remain seated and buckled in at the back of that ambulance, as opposed to standing up and trying to do CPR in a moving vehicle,” explains Pollock.

Users of Lucas also say having the device on scene changes the nature of the event, making it less chaotic. With an automated system, responders can maintain their calm and focus on the next step in the rescue process. “We know that humans can’t possibly keep up high quality 2-inch depth, 100 compressions per minute CPR over long periods of time but Lucas can,” Pollock says.
Philips Healthcare, which markets the HeartStart line of defibrillators, also equips its devices with CPR coaching to assist with the rescue.

Emphasis on connectivity
Another trend in the defibrillator industry is a focus on improved connectivity and access to data. Zoll’s Hamilton says customers enjoy the span of communications allotted to them by smartphones and products such as iPads. Now, they look for the same abilities in defibrillator products, wanting “better, quicker and easier access” to the event information, he says.

Hospital users looking for connectivity can choose a Zoll defibrillator from the company’s R Series line. “It has communications capabilities, in particular Wi-Fi, so [the unit] can talk to a Wi-Fi network at a hospital and send data to that network in case of an event,” says Hamilton.

Zoll has also recently added Wi-Fi capability to its E Series products for emergency medical service professionals.

Physio-Control’s Pollock backs up this trend. He says customers are increasingly looking for ways to get information about patients sooner, embed it into patients’ electronic health records and deliver the data to hospital staff ahead of the patient’s arrival.

The company offers a subscription-based Web data network called Lifenet. The service started off as a transmission system for 12-lead ECG data and can now be used to track defibrillator features such as battery and pads status.
A customer using Lifenet can connect an EMS system to a hospital and move data directly from the field to a cath lab or an ER department, thus reducing the door-to-balloon time, says Pollock.

Physio-Control has more than 11,000 of its Lifepak defibrillators on the network and about 1,100 hospitals signed up so far. “The goal is to have every device on it,” Pollock says.

AED upkeep
In its 2010 guidelines, AHA also emphasized the need for quality improvement initiatives. But a well managed SCA event can only be successful if the AED is ready to deliver a shock at the right moment.

To ensure the devices are always on standby in working condition, several companies offer a variety of AED maintenance programs.

Philips has an AED data management program called Smart Track, a Web-based system that monitors expiration dates, responder training records and other AED details, says Jamie Froman, global director of marketing, HeartStart AEDs, Philips Healthcare.

“It’s a whole system program management software that helps support the AED program administrator at a school, a health club or another institution,” says Froman. “It helps assure their overall program’s readiness for use.”

eMed America, a company that sells AEDs from a number of manufacturers, also has an online AED program management option. “It’s a Web-based software program that monitors and maintains every defibrillator that we put out into service,” says Ben J. Wellons, the company’s president and CEO. “It also monitors the trained personnel at each location so we can make sure they get retrained and refreshed every year.”

Currently, more than 2,000 of eMed’s customers are using the management program. “Owning or buying a defibrillator is only the first part of the equation to be prepared to save someone’s life,” Wellons says.

Defibtech’s Slusser says the company’s Lifeline View unit is a “benchmark in AED maintenance.”

“The pads and the batteries are programmed with the serial number and expiration dates,” Slusser says. “When they’re replaced, it automatically interacts with the unit to load that information directly to the status screen.”

In addition to the subscription-based maintenance programs, most AEDs are also designed to run a number of self-tests. For instance, if the batteries are low or the pads need to be replaced, the unit is programmed to emit an audible warning.

Philips’ units have an extensive suite of self-tests, according to Froman. “There’s more computing power devoted to the self-testing than anything else,” he says.

Challenges -- FDA and…bystanders?
Although most AED makers say business has been steady or up in the past year or so, the sector is not without challenges. A new Food and Drug Administration initiative and a recent study assessing the public’s relationship with AEDs present some obstacles to manufacturers.

Last year, the FDA launched a new AED initiative as a response to the thousands of reports it received regarding external defibrillator malfunctions.

The goals of the agency’s External Defibrillator Improvement Initiative include promoting innovation to enhance AED safety and improving the industry’s ability to pinpoint and resolve safety risks in a faster and more effective manner.

The FDA also vowed to establish a premarket regulatory pathway for AEDs that incorporate best practices for design and product testing.

Although manufacturers commend the FDA for the initiative, it’s worth noting that it will affect, and potentially slow down, the approval process for new AEDs. “It may require more time and more data as part of the effort to improve reliability,” says Zoll’s Hamilton.

Nevertheless, industry experts believe by working with the FDA on the improvement initiative, defibrillator products already on the market will not be significantly impacted.

In addition to forthcoming regulatory changes to AED manufacturing, companies also have to deal with the public’s qualms about AED use.

In a recent study published in the journal Annals of Emergency Medicine, researchers surveyed 1,018 people from 38 different countries at the Central Railway Station of Amsterdam, a busy travel hub that’s also AED-equipped.

The researchers found that only 47 percent of those surveyed would be willing to use an AED and a little more than half (53 percent) of those surveyed couldn’t even recognize the device.

“Only a minority of individuals demonstrate sufficient knowledge and willingness to operate an AED, suggesting that the public is not yet sufficiently prepare for the role it is destined for,” the study’s authors wrote.

To deal with such a challenge, companies are continuously working to raise awareness about the incidence of SCA by investing in educational campaigns and initiatives. And with the potential bystander reluctance to use an AED in mind, manufacturers are also working to make the device less intimidating and more user-friendly.

Every AED on the market is capable of delivering an electric shock, says Defibtech’s Slusser. “But in the hands of a lay person, we need more than just a piece of electronics that has the ability to deliver a shock,” he says. “We have to understand how people use them, the stress associated with those events and the trepidations that they may have about using AEDs.”

DOTmed Registered Defibrillator Companies

Names in boldface are Premium Listings.
Domestic
Ben J Wellons, eMED, AR
DOTmed Certified
Kirk Marshall, Global Medical Devices,Inc, CA
Arnold Wiesel, MFI Medical, CA
DOTmed Certified
Lisa Vanasco, Ready Medical, CA
Peter Leonidas, Soma Technology, CT
DOTmed 100
James Fowler, BioMed Techs Inc, FL
Moshe Alkalay, Hi Tech Int'l Group, FL
DOTmed Certified
Clinton Courson, Quest Medical Supply, Inc., FL
DOTmed 100
Richard Fosco, HealthWare Inc., IL
DOTmed Certified
Dennis Swaggert, Heartland Medical Sales/Service, KY
Alda Clemmey, Saffire Medical, MA
DOTmed Certified
DOTmed 100
John Gladstein, Medical Device Depot, MD
DOTmed Certified
Tom Kohman, Universal Hospital Services, MN
Peter Stuart, Universal Hospital Services, Inc., MN
Anwar Syed, Global Medical Parts on Line, MO
Robert Ward, Innovative Service Solutions, LLC, MS
George Fraza, DMS Topline Medical, ND
DOTmed 100
Alison Fortin, Global Inventory Management LLC, NH
DOTmed Certified
DOTmed 100
Abe Sokol, Absolute Medical Equipment, NY
DOTmed Certified
DOTmed 100
Robert Schirano, Finger Lakes Medical Supply LLC, NY
Mohan Das, Netech Corporation, NY
Philip Mothena, Simple Solutions, Inc., VA

International
willem willemse, labbay bv, Netherlands
jorge sandoval, empresa sandoval, Mexico
An Min, mindray Co,Ltd, Hong Kong
Jose Pinto, American Medical Systems And Supplies, S.A, Honduras
ALESSANDRO NORDI, PROGETTI SRL, Italy
Noor Mohamed, sms enterprises, India