DOTmedbusiness news I july 2011 43

& the publicDefibrillators

In line with the latest guidelines, AEDs look to deliver more than a shock By Olga Deshchenko

Last April, Vanessa Seale, a 30-year-old health teacher and coach at a Texan mid-dle 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 car-diopulmonary resuscitation and asked someone to get the automatic external defibrillator, hanging in a wall-mount-ed 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 syn-drome, 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 adminis-tering aid to someone suffering from

Courtesy of Defibtech

DOTmedbusiness news I july 2011 www.dotmed.com44

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 de-vices are as user-friendly as possible. More recently, compa-nies have also placed a bigger emphasis on the role of AEDs in the facilitation of the entire resuscitation process.

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

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

In response to AHA’s renewed focus, manufactur-ers 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 per-formance 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 of-fers 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 immedi-ately 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-fo-cused product for its medical emergency response custom-ers. This winter, Physio-Control completed the acquisition of the Swedish company Jolife AB, the maker of the Lucas

Refurb market is charged upFor companies like Dixie Medical, a seller of refurbished de-fibrillators, business is booming– its business was up by 25 percent last year. “I think that in the past certain customers that would have never considered buying refurbished prod-ucts are now being forced to look at that option because of tight budgets,” says Matt Spencer, the company’s president.

Some of the most popular devices currently in demand are the Zoll AED Plus, Cardiac Science Powerheart AED 3G units and Physio-Control’s Lifepak CR Plus AED, according to Spencer.

Customers can save between 30 and 40 percent if they choose to purchase a defibrillator on the refurbished mar-ket, Spencer says.

The demand for refurbished products has even attracted some OEMs to the business. Last year, Physio-Control launched its Refurbished Equipment from the Lifesaving In-novators (RELI) program.

As many of the company’s customers are switching to the latest Lifepak 15 monitor/defibrillator, they’re trading in their Lifepak 12 models, which Physio-Control then puts through a complete factory refurbishment process.

According to Cam Pollock, the company’s vice president of global marketing, a customer can purchase a refurbished Lifepak 12 for about 25 to 35 percent less than the cost of a new Lifepack 15.

So far, the RELI program has been a hit for the company. “We’ve been selling everything we’ve got,” says Pollock.

Physio-Control plans to have all of its Lifepak products as part of the RELI program in the future.

• Online: dotmed.com/dm16378

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Chest Compression System.Lucas is an automated compres-

sion device that enables rescuers to deliver quality, uninterrupted com-pressions. The product has been pop-ular with Physio-Control’s customers and the recent AHA guidelines up-dates 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 re-quires 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, respond-

ers 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 mar-kets the HeartStart line of defibrilla-tors, also equips its devices with CPR coaching to assist with the rescue.

Emphasis on connectivityAnother trend in the defibrillator in-dustry is a focus on improved connec-tivity and access to data. Zoll’s Ham-ilton says customers enjoy the span of communications allotted to them by smartphones and products such as iP-ads. Now, they look for the same abili-ties in defibrillator products, wanting “better, quicker and easier access” to the event information, he says.

Hospital users looking for con-nectivity can choose a Zoll defibrilla-tor 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 profes-sionals.

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

The company offers a subscrip-tion-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 de-fibrillator features such as battery and pads status.

A customer using Lifenet can con-nect an EMS system to a hospital and move data directly from the field to a cath lab or an ER department, thus re-ducing the door-to-balloon time, says Pollock.

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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 upkeepIn its 2010 guidelines, AHA also em-phasized the need for quality im-provement initiatives. But a well man-aged 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, sev-eral companies offer a variety of AED maintenance programs.

Philips has an AED data manage-ment program called Smart Track, a Web-based system that monitors expiration dates, responder train-ing 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 sup-port the AED program administrator at a school, a health club or another institution,” says Froman. “It helps assure their overall program’s readi-ness for use.”

eMed America, a company that sells AEDs from a number of manu-

facturers, also has an online AED program management option. “It’s a Web-based software program that monitors and maintains every defi-brillator 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 man-agement program. “Owning or buy-ing 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 com-pany’s Lifeline View unit is a “bench-mark in AED maintenance.”

“The pads and the batteries are programmed with the serial number and expiration dates,” Slusser says. “When they’re replaced, it automati-cally 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 num-ber 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 Fro-man. “There’s more computing power devoted to the self-testing than any-thing else,” he says.

Challenges — FDA and…bystanders?Although most AED makers say busi-ness 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 relation-ship with AEDs present some obsta-cles to manufacturers.

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

The goals of the agency’s External Defibrillator Improvement Initiative include promoting innovation to en-hance AED safety and improving the industry’s ability to pinpoint and re-

DOTmedbusiness news I july 2011 47

solve 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 com-mend 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 re-quire 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, defibril-lator products already on the market will not be significantly impacted.

In addition to forthcoming regu-latory changes to AED manufactur-ing, 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 Am-sterdam, 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, sug-gesting that the public is not yet suf-ficiently prepare for the role it is des-tined 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 ca-pable 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.” • Online: dotmed.com/dm16377

Olga Deshchenko can be reached via email at olga@dotmed.com

DOTmed Registered Defibrillator Sales & Service CompaniesFor convenient links to these companies, go to www.dotmed.com and enter [DM 16377 ]Names in boldface are Premium Listings.Name Company - Domestic City State Certified DM100 Ben J Wellons eMED Little Rock AR • Kirk Marshall Global Medical Devices,Inc El Cajon CA Kenn Matayor Jaken Medical Inc. Chino CA •Arnold Wiesel MFI Medical San Diego CA • Lisa Vanasco Ready Medical Paramount CA Ramon Manalo Jr. Requests International Stevenson Ranch CA Greg Slusser Defibtech Guilford CTPeter Leonidas Soma Technology Bloomfield CT •James Fowler BioMed Techs Inc Gainesville FL Moshe Alkalay Hi Tech Int’l Group Boca Raton FL • Carlos Vargas INCAV Orange City FL • Clinton Courson Quest Medical Supply, Inc. Longwood FL •Richard Fosco HealthWare Inc. Oak Brook IL • Dennis Swaggert Heartland Medical Sales/Service Louisville KY Garret Purrington Medical Equipment Dynamics, Inc. New Bedford MA •Contact Support Philips HeartStart AED Andover MAAlda Clemmey Saffire Medical Taunton MA • •John Gladstein Medical Device Depot Ellicott City MD • Jamie Saltzman Zoll Medical Corporation Chelmsford MATom Kohman Universal Hospital Services Bloomington MN Peter Stuart Universal Hospital Services, Inc. Edina MN Ben Eden Bio Basics Global Park Hills MO Anwar Syed Global Medical Parts on Line Saint Louis MO Robert Ward Innovative Service Solutions, LLC Hattiesburg MS George Fraza DMS Topline Medical Fargo ND •Shanna Flanagan DMS Health Technologies Fargo ND •Alison Fortin Global Inventory Management LLC Dover NH • •Abe Sokol Absolute Medical Equipment Wesley Hills NY • •Robert Schirano Finger Lakes Medical Supply LLC Spencerport NY Marc Todd Longevity, LLC Brooklyn NY • •Mohan Das Netech Corporation Farmingdale NY Victor Landeros OMED Reno NV Julie Gutterman Pulse Consultants Mason OH Jarrod Handley Dixie Medical Franklin TN •Philip Mothena Simple Solutions, Inc. Blacksburg VA Cam Pollock Physio-Control Redmond WA Name Company-International City Country Certified DM 100Jose Pinto American Medical Systems And Supplies, S.A La Ceiba Honduras An Min Mindray Co,Ltd Shenzhen Hong Kong Noor Mohamed sms enterprises Chennai India ALESSANDRO NORDI PROGETTI SRL Torino Italy Jorge Sandoval Empresa Sandoval Otay Nva Tijuana Mexico Willem Willemse Labbay bv Geldermalsen Netherlands