Automated External Defibrillators (AEDs) A detailed review of the leading manufacturers.

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1 Page 1 of 29 DOWNLOAD AED COMPETITIVE REPORT Fall 2003 Report If you are a manufacturer and would like us to re-evaluate your device or have made changes to your device since our review, please contact us at tech@aedsurvivors.org or Survivors Foundation P.O. Box 432 Chatham NJ We tried to be honest and thorough in our evaluation and to disregard our management's relationships with the various manufacturers to give you an objective review. Members of our management team are, or intend to be, involved with the sale of automated external defibrillators and their findings have influenced our research efforts and our findings which have altered their decisions with regard to which devices they have chosen to distribute. We suggest that you do your own research before purchasing an automated external defibrillator. We think that you will discover similar findings. From time to time we accept contributions to continue our efforts; but intend on remaining non biased. Our efforts are to expand public knowledge and distribution of automated external defibrillators. James Bock, President & Founder, EMT-B & CPR Instructor Automated External Defibrillators (AEDs) A detailed review of the leading manufacturers. According to the American Heart Association, every year 460,000 deaths arise in the United States from Sudden cardiac arrest. Sudden cardiac arrest (SCA) occurs when the lower chambers of the heart (the ventricles) suddenly stop beating normally and develop what is called ventricular fibrillation (VF). VF is a chaotic heart rhythm that is similar where the heart muscle begins quivering which prevents the heart from effectively pumping blood. If this condition is not corrected immediately; death will follow within 10 minutes. A defibrillator is the only known device/technique that stops the chaotic electrical heart activity and allows the heart to re-pace itself to a normal rhythm. Occasionally, the heart will re-pace itself (5% of incidents); and if the patient has received Cardio Pulmonary Resuscitation (CPR) in this instance; a patient will survive. Utilizing a defibrillator increases the odds of survival from 5% with just CPR to as much as 80% if a Defibrillator is placed on the patient within a few minutes of Sudden Cardiac Arrest. Not only is it essential that a defibrillator be utilized in such events, but that a defibrillator is accessible within a few minutes of a cardiac arrest. For every minute following onset of sudden cardiac arrest, the chance of that person's survival drops by 10%. As such, waiting for the arrival of an ambulance or police car for just 6 minutes will reduce the opportunity for more than half of all patients to receive a successful resuscitation outcome. Because of increasing awareness and demand, the leading manufacturers of defibrillators began producing a new device which required very little training, was portable and relatively inexpensive; the Automated External Defibrillator (AED). On November 13, 2000 President Clinton signed the Cardiac Arrest Survival Act. This represents the most comprehensive Good Samaritan legislation ever established which provides complete immunity from civil litigation for ALL PEOPLE USING AN

2 Page 2 of 29 AED. Shortly thereafter, the Airlines began getting sued by family members of people who might have been saved had the airlines provided access to an AED. Businesses now take the initiative to invest in AEDs rather than expose themselves to the types of lawsuits that were initiated shortly after the introduction of the fire extinguisher. Although all AEDs available in the USA are FDA approved for sale and operates under the same basic principles; not all AEDs are created equally, as manufacturing standards vary. Our team reviewed manufacturers evaluating materials utilized for construction; unit functionality; safety of rescuers; pricing, technologies and financial stability of manufacturer. When it comes to the life or death of a loved one or co-worker we think you should make an informed decision. To assess this, the units of major manufacturers were taken apart, tested and critiqued from every conceivable angle by medical professionals and the results were as follows: General Impressions Scale: Terrible, Poor, Fair, Good, Excellent 1. Medtronic Physio-Control GENERAL AREAS OF CONCERN: Batteries: Fair PADS: Good Water Resistance: Poor Financial Stability of Manufacturer: Good Ease of Use: Good Electrode Connections: Terrible Airway Management: Terrible CPR Assistance: Terrible Pricing: Good Medtronic produces two AED's; the LifePak CR plus and the LifePak 500. The LifePak CR plus is designed for the minimally trained, infrequent rescuer while the LifePak 500 is a more industrial, rugged AED designed for frequent use. Medtronic Physio-control was one of the pioneers of the AED industry over fifty years ago. They provide some of the highest quality sources of support. Including the launching of the Heart Safe Communities initiative in 2000, which focuses on the goal of saving lives in communities where this program is implemented. Medtronic has also been involved in the development PDA's, extending the awareness of Public Access Defibrillation.

3 Page 3 of 29 Medtronic s LifePak CRPlus Medtronic s LifePak 500 The LP500 offers a monophasic and biphasic choice, ranging from $3585-$3928. The cost of this machine far surpasses the cost of most AED's on the market. When tested we had concerns that the LifePak500 was too confusing to operate and the LifePak CRPlus was poorly constructed and company personnel were advising customers that the CRPlus was NOT to be used outdoors. CPR is just as important in a life saving situation as having an AED. That is why experts were surprised to find that there is no prompt in the instructions of the Physio AED's to remind the user of performing

4 Page 4 of 29 CPR. This was a surprising and scary find. There are no warnings of pre-defibrillation safety. Often, when one is dying, there is a great chance that they have a closed airway passage. Tilting the patient's head is a vital step in saving their life. It seems that much more thought should have been put into these products before they were released on the market. Perhaps major AED manufacturers need to be reminded that this is a business of saving lives, and a little more thought being put into their products wouldn t hurt anybody. LifePak500 Unit with Proprietary Battery LifePak CRPlus Proprietary Battery

5 Page 5 of 29 LifePak CRPlus Accessory Pack (best kit available) LifePak CRPlus Pads connections tend to rip off when removing

6 Page 6 of 29 LifePak CRPlus cover is constructed of thin brittle plastic and easily breaks To buy LifePak units contact 2. Cardiac Science GENERAL AREAS OF CONCERN: Batteries: Good PADS: Good Water Resistance: Terrible Financial Stability of Manufacturer: Good Ease of Use: Fair Electrode Connections: Terrible Airway Management: Terrible CPR Assistance: Terrible Pricing: Good Cardiac Science provides two AED models, the Powerheart for the less experienced users and the more professional Diascope g2. The Powerheart is equipped with pre-connected electrodes that are included in the daily self-test. It also provides a visible battery capacity gauge and full energy self testing. Cardiac Science has gained a patented on/off signal during which every time the lid opens the machine turns on.

7 Page 7 of 29 These features and others make the Powerheart AED quicker to use then almost any other AED on the market. Cardiac Science PowerHeart PowerHeart Proprietary Battery After appreciating the significant qualities of the Cardiac Science AED's, the Survivors Foundation looked closer for any possible faults this machine might have. Among the most serious was the dangerously weak connection of the electrode pads to the Powerheart AED. The electrode pads channel the defibrillating shock to the body of the victim. Without a connection to the power source itself, these pads are deemed worthless. The uncomforting discovery was found that with only a light tug of the wire, the plug for the electrode pads was effortlessly yanked from the AED. The scene of disaster is fearful and chaotic. There are usually crowds and commotion around the dying victim. In the vital first minutes

8 Page 8 of 29 after the heart goes into defibrillation, an AED is a life saving factor. In the commotion of this life or death situation, a small amount of pressure being put on these wires could result in a fatal mistake. This mistake is not to be blamed on an innocent good samaritan who attempts to save a life with an AED. The blame is to be put on the manufacturers themselves. PowerHeart connections easily come undone Cardiac Science brags about the feature that automatically turns on the machine when the lid to the AED is opened. This feature is extremely helpful for quick access saving precious seconds. On the other hand, the machine is also turned off when the lid is closed for a few moments. When looked at closely, experts found that the lid had no locking mechanism when opened. In fact, the hinges on the lid were quite flimsy and a small bump in the wrong direction could cause the lid to close suddenly. In a scene of chaos such as this, it cannot be expected by the laymen who this AED was designed for to be able to notice such a seemingly minute detail as a closing lid. However, it cannot help but be noticed when the machine turns off in the middle of administering shocks to a dying person.

9 Page 9 of 29 PowerHeart Unit Shuts Off When Accidentally Closed Many other faults were found as well. For example, there is virtually no way to avoid the extremely adhesive pads on the electrodes from sticking to bare skin or gloves. This may sound like a minute detail, but seconds spent fiddling with sticky pads are crucial in the situations this product was designed for. Especially with distractions such as crowds, yelling, sirens and bad weather such as rain. Yet, this is not a product one would want to use the rain anyway. The battery seal has a water resistance of IPX4. This means that it can withstand only a light spray of water. The PowerHeart was designed under the assumption that heart failures don't happen in pouring rain. The Powerheart, unlike some of its competitors, displays only the audio prompts, number of shocks and elapsed time. The screen does not allow for an ALS user to analyze the ECG. This product will work fine and may save lives, given that the situation is without certain types of complications. The effectiveness of a product of this importance based on those terms is not a gamble worth betting a life on. To buy PowerHeart units contact 3. Philips Corporation GENERAL AREAS OF CONCERN: Batteries: Good PADS: Good Water Resistance: Poor Financial Stability of Manufacturer: Excellent

10 Page 10 of 29 Ease of Use: Excellent Electrode Connections: Excellent Airway Management: Terrible CPR Assistance: Terrible Pricing: Good The company Phillips has been bringing consumers high quality products in the field of TV, video, and audio for years. They can be trusted to bring us all the latest technology in the entertainment business. The Survivors Foundation sat down to conduct a series of important safety, convenience and durability tests a few problems surfaced with the Phillips AtHome and FR2 AED's. Not unlike most other large manufacturers of AED's, Phillip's provides two mainstream AED's. The AtHome a.k.a. OnSite is a simpler and also more fragile AED designed for laymen use. The FR2 is a more rugged, durable and has the ability to manually override the AED function for ALS responders. Although we can all count on the new Phillip's flat screen TV to be a reliable source of our weekly dose of Friends, we felt hesitant to go to the same source for a device used for saving lives. With this in mind, the At Home and FR2 AED's were put through especially close examination by the Survivors Foundation. The FR2 is a rugged, durable, manual product designed for professional use.

11 Page 11 of 29 Philips HeartStart Onsite & At Home Units are Identical HeartStart has little to no Water Resistance to Battery Compartment

12 Page 12 of 29 Thin Plastic Easily Breaks Leaving PowerHeart Unit Unusable Sticky Pads are a serious concern with all units reviewed except the ZOLL AED Unit

13 Page 13 of 29 HeartStart Proprietary Battery uses Consumer Batteries repackaged and sealed in plastic case at ten times the cost! Through research, they found that Phillips AED has pioneered the science of pediatric defibrillation. At first it seemed disturbing that the same amount of joules (50) was used on a 55 lb. eight year old as an infant. This seemed irresponsible and dangerous to children. Nevertheless, in Phillips' defense, a child who receives an AED treatment is almost always already clinically dead. Even though there might be a safer pediatric treatment in the near future. It's better to give children who go into SCA a risky chance then none at all. Phillips has helped give these children a chance. At first glance this seemed like a solid product. However, there were many subtle imperfections in this extremely important device. First, the electrode pads were insufficient for quick application to a dying person. Like almost every other AED that was inspected, there is no way to apply the pads to a patient without wasting vital seconds un-sticking one's self from the extremely adhesive pads. This may sound like a minor detail to most, but when it's your father laying on the ground with his heart going into defibrillation, seconds count. Not to mention that because Phillips has so many other products they're dealing with, they don't make they're own pads. At the time these tests were conducted, August 18th 2003, we were told that there was a three week backup on receiving pads for Phillip's AED's. Since the pads are single use only, this could be a fatal incident. To buy HeartStart units contact 4. ZOLL AED GENERAL AREAS OF CONCERN: Batteries: Excellent PADS: Excellent

14 Page 14 of 29 Water Resistance: Excellent Financial Stability of Manufacturer: Excellent Ease of Use: Excellent Electrode Connections: Good Airway Management: Excellent CPR Assistance: Excellent Pricing: Excellent ZOLL s AED Plus Creative. Innovative. Practical. All words that came to mind when we examined the ZOLL AED Plus. It was an effort in itself just finding even the most diminutive of flaws. We were pleased to find that we failed in finding any faults of significant importance in this product. All that really stood out was that the ZOLL AED Plus might not be the most financially efficient for those who would use an AED often. This particular AED is really designed to be used easily by somebody with not so much experience. Nevertheless, even the most highly trained officials can panic under pressure and the ZOLL AED Plus offers them the support they need. It can also be configured to skip certain steps if an ALS responder is the primary user of the unit, which can save precious seconds. The biggest issues with ZOLL s units don t really relate to the product itself but more with the company s transition from distributing to hospitals to distributing to the public. ZOLL s conservative credit terms and rigid attitude from within the organization when communicating with distributors creates unnecessary shortages of product and can alienate even their biggest distributors. ZOLL s credit terms are far less favorable than competitors and distributors have significant restrictions in distributing to police, fire and EMS due to direct sales initiatives. On their behalf, processes are much easier to correct than product issues and it will interesting to see how these issues are responded to over the next few months.

15 Page 15 of 29 ZOLL s AED gets 1st Place Award from Product Design and Development & Best Rated AED from ECRI (the Emergency Care Research Institute) ZOLL seems to have employed the same thorough approach to building an AED as they put into building their M-Series which has been the leader in defibrillators in use in the best teaching hospitals around the world. ZOLL conducted intensive focus studies among EMS personnel prior to launching its AED product. The ZOLL s AED Plus has more unique features then any of the other AED's we evaluated. The most impressive of these features are those that focus on the CPR portion of resuscitating a patient. ZOLL provides a step-by-step prompt, guiding its user through the CPR process. The lid of the AED doubleacts as a head tilt chin lift, opening the patient s airway while the resuscitation process is in effect. Most inexperienced users are too timid while performing the chest compressions of CPR. The ZOLL AED Plus has a CPR puck strategically placed between the convenient one piece electrodes that provides constant feedback to the rescuer on compression depth and rate. The AED Plus provides you with audio reassurance that the compression depth being applied is sufficient or if you need to Push Harder. The AED Plus also provides the rescuer with an adaptive metronome which gradually increases speed to bring the rescuer up to the proper amount of compressions per minute. The one piece electrode system; which fits 99% of patients helps the user to avoid misplacing the electrode pads and can be adapted by pulling the pin on the apex electrode and placing appropriately on the larger patient.

16 Page 16 of 29 ZOLL s One Piece Pad System Coaches Rescuer through CPR Compressions There are many more advantages to using the ZOLL AED Plus. The picture instruction prompt coincides with the audio prompt making it accessible for use to the hearing impaired or those who are having trouble hearing due to loud noises and commotion which usually comes hand and hand with emergency. The user friendly device uses consumer type 123 batteries. This makes it possible to buy new batteries at a fraction of the price of ZOLL s competitors. The battery system only uses half the batteries it has stored so if something goes wrong with a few of them, there are backups already in place. Among the most impressive of qualities was the creative design of the electrode pads. Not only the extremely efficient one piece design, but the easy pull system which was the only pads that could be readied for use extremely fast without fumbling with the adhesive gel on the pads. It s because of ZOLL s extensive and careful planning and out of the box thinking that won them an award from the Emergency Care Research Institute (ECRI). Needless to say as a result of our studies, we also rank the ZOLL AED Plus to be the all around best AED on the market. ZOLL prevails in the areas of user friendliness, reasonable pricing, safety and effort towards improvement.

17 Page 17 of 29 PASS Cover Slides under Shoulders of Patient to create Patent Airway Individually Installed Consumer Batteries Creates Significant Redundancy for defective batteries in Water Tight Sealed Compartment To buy the Zoll unit contact 5. Welch Allyn

18 Page 18 of 29 GENERAL AREAS OF CONCERN: Batteries: Fair PADS: Good Water Resistance: Good Financial Stability of Manufacturer: Good Ease of Use: Good Electrode Connections: Excellent Airway Management: Terrible CPR Assistance: Terrible Pricing: Excellent Formally known as the MRL, Welch Allyn provides two basic AED s the AED 10 and the AED 20. The AED 10 is the laymen s version, the AED 20 being devoted to professional use only. Our experts were pleased to find a strong connection from the electrode pads to the AED itself. Another feature our experts liked was the clear audio prompts which were accompanied by clear visual prompts to help direct the rescuer s actions. The color coded defibrillation system is designed for beginners to use without delay, making it fast and easy to use. The Welch Allyn has a unique design where the battery double-acts as a handle for the unit. This

19 Page 19 of 29 seemed to be an inefficient design considering the battery would be the first thing damaged in the event the unit was dropped. Another damage risk is the inefficient way the electrode pads hang unprotected from the AED. There is no storage capacity for this necessary part of the unit. Welch Allyn Pads are too big to fit packaged with unit Like almost every other AED that was examined, the electrode pads on this unit have no way system of peeling off without getting the user stuck to them wasting precious seconds. In addition, there is no prompt for CPR instructions in this device leaving the user vulnerable to forgetting the important life

20 Page 20 of 29 saving procedures. We found it of no use to revive a patient with an AED only to let them suffocate because the proper system was not implemented. Proprietary Battery Welch Allyn unit has easy to lose screws that never tighten

21 Page 21 of 29 Nice firm connection To buy the MRL units contact 6. Heartsine Technologies GENERAL AREAS OF CONCERN: Batteries: Fair PADS: Good Water Resistance: Poor Financial Stability of Manufacturer: Terrible Ease of Use: Good Electrode Connections: Fair Airway Management: Terrible CPR Assistance: Terrible

22 Page 22 of 29 Pricing: Good HeartSine Technologies was founded in 1997 with the prime goal to develop innovative yet affordable life-saving technologies for cardiology applications principally their Samaritan AED. At first glance the Samaritan AED looks like a viable contender in the AED lineup. However after researching company operations and financial capacity, we have cause for concern. Samaritan AED

23 Page 23 of 29 Samaritan's BIG Display is Very Cool; but who knows how to interpret it? Samaritan's Proprietary Battery

24 Page 24 of 29 Samaritan's Pads are just as sticky and unmanagable as the other two piece systems Based in Belfast Northern Ireland, HeartSine employs 21 people and are the only domestic (UK) manufacturer of Automated External defibrillators. HeartSine s investors include ACT Venture Capital, Crescent Capital Venture Fund and University Challenge Fund which reportedly invested a total, of just over a million dollars (US); not much of a cushion for research and development nor adequate financial protection in the event of faulty manufacturing processes. In fact according to financial reports filed with the SEC it took 4 years for Cardiac Science to recover a $260,000 debt owed them by HeartSine; as the financial condition of HeartSine warranted Cardiac Science to write off the debt. Imagine a lawsuit in the millions of dollars for just a single death; HeartSine apparently, as financed, is ill-equipped to assume the financial responsibility of manufacturing medical devices. When testing a LIVE unit on a woman in our office; the Samaritan indicated "SHOCK ADVISED". Well we all agreed that this individual is not the most exciting person we've ever encountered; she was conscious and alert during the test. This sort of mistake will inevitably happen in the field and when it does there will be serious consequences. We also noticed that the heart rate and rhythm changed as we changed pad locations on the chest.

25 Page 25 of 29 Given the political instability of Belfast, the apparent lack of financial capital, our live test results and age of the manufacturer; we have serious reservations with the Samaritan AED. To buy the Samaritan unit contact 7. Access CardioSystems GENERAL AREAS OF CONCERN: Batteries: Terrible PADS: Terrible Water Resistance: Terrible Financial Stability of Manufacturer: Terrible Ease of Use: Fair Electrode Connections: Terrible Airway Management: Terrible CPR Assistance: Terrible Pricing: Excellent

26 Page 26 of 29 The Access AED is the easiest AED to transport being it is the smallest, lightest and inexpensive AED on the market. Small Size Undoubtable Attractive; but at what cost?

27 Page 27 of 29 Access Proprietary Battery Unfortunately, our panel of experts indicated that the cheap price of the product seemed to coincide with its quality. Poor connection and flimsy construction coincide with the numerous complaints from employees not receiving pay checks and suppliers not being paid. Our experts interviewed several former distributors of the Access AED who received numerous complaints about the product. One distributor reported discontinuing sales of the AED due to numerous incidents of the Access failing its self-test and complaints from customers; that after a week the battery just quit. As many consumers found Access to be an unacceptable alternative so did our experts. The case with an AED is that sometimes an inferior product is better then no product at all. Unfortunately, in this case, where lives are literally on the line, this product is worst then no product at all as utilizing an AED that may not work is likely to delay reaching out for additional resources in an actual emergency. To purchase the Access's Unit contact OUR CONCLUSIONS: It seems obvious that an essential search to purchase an Automated External Defibrillator should be among the viable contenders and that could only include the manufacturers that are adequately financed to assume all the responsibilities associated with manufacturing a medical device. Although attractively priced HeartSine s Samaritan AED and Access CardioSystem s AED can not seriously be considered because they just don t have the money to play in the game. Medtronic Physio-Control; Welch Allyn; ZOLL AED, Cardiac Science and Philips Corporation all have fairly deep pockets and in our opinion manufacture high quality AED units. Of these manufacturers one manufacturer clearly stands out in the crowd; ZOLL Medical. Although we had concerns about consumers getting product in a timely fashion because of restrictive credit terms Gestapo collection techniques placed upon distributors we are convinced that ZOLL will match competitor s eagerness to facilitate improved relations with distributors and product will be available for the increasing demand. Our research indicates that ZOLL conducted extensive research utilizing 1 ½ years of focus studies where senior management interviewed countless professionals in EMS, Police &

28 Page 28 of 29 Fire whom had used AED s in a professional setting and had concerns. ZOLL not only listened to these concerns but integrated a response to these concerns in their ZOLL AED Plus unit. Concerns that professionals had were as follows: a) Incorrect pad placement by 1st Responders ZOLL created one piece pads eliminating incorrect pad placement and pads sticking to rescuer s gloved hands, ZOLL also rocked the industry by creating the longest life pads 4 years; b) Disturbing confusion exhibited by just about all first time 1st Responders that performed CPR (ribs separating from sternum) ZOLL introduced Compression Puck that measures depth and rate of CPR compressions and provides verbal feedback and assurance that CPR is performed correctly; c) Patients suffocating after heart is revived by improper or no airway management by 1st Responders ZOLL created the PASS (Passive Airway Support System) for their unit, which utilizes the unit s cover to slide under the patient s shoulder blades, thus creating a patent airway; d) Although NO known accidents have occurred where a unit got wet and caused a fire to start or a rescuer to be injured or killed, it was an accident waiting to happen by the fact that NO AED manufacturer provided protection for rescuer s by incorporating significant water resistance ZOLL rather than wait for the inevitable and demonstrate the industry s norm of willful ignorance integrated by far the most resistance AED to water; e) Where an elderly person attempted to utilize an AED on a mate or fellow patient they were frequently hard of hearing and misunderstood the voice prompts ZOLL integrated illuminated pictures for each portion of the rescue that guide children, the hard of hearing and the elderly on proper use of their AED; Where batteries sometimes died unexpectedly by being exposed to extreme temperatures and moisture, rescuers were at the mercy of the AED companies for proprietary batteries and forced to stock multiple high priced batteries ($ $350.00) ZOLL integrated consumer lithium batteries manufactured by companies that actually know what they are doing. ZOLL s unit utilizes 10 separately installed consumer batteries that provide tremendous redundancy because up to 5 batteries can die and the unit still remains functional. The cost of replacement batteries for ZOLL s unit when searching the Internet was just $25 for all ten batteries; f) Although it almost never happens that an infant develops Sudden Cardiac Arrest as a result of anything but obstructed airway in which case the airway must be cleared before reviving the heart, many politically minded companies utilizing scare tactics rushed to the table and offering Pediatric Pads for an AED. In fact the American Heart Association s position on CPR instructors teaching AED use on an infant optional. We find selecting an ARD to use on infants ridiculous, of the EMS and emergency nursing staff interviewed none thought an AED purchase for use on an infant was warranted. However, with that in mind all the manufacturers are addressing the political issue of pediatric pads. The position that most manufacturers have taken is that since the unit would most likely not be used on an infant not much money would be invested in development; therefore the only modification we were able to determine was that the amount of joules administered to the patient was decreased by using a resister. This may seem like a viable alternative but in the rare case of an infant actually needing a defibrillator from an extreme fall or electric shock such an alternative of limiting the joules might seem like a viable option but when interviewing ZOLL s employees we discovered the obvious; that infants have different body composition than adults and require not only less joules but a different wave form specifically developed for infant s muscle, tissue and bone density ZOLL s pediatric pads (expected December 2003) are the only pads to address the infant s unique body structure. Not only did ZOLL make considerable improvements to the units on the market they changed the playing field, they did so by introducing a product that was approximately $1000 less than competitive models. The other manufacturers have begun to respond with Philips developing a one-piece pad system (due to market 2nd quarter 2004) and manufacturers developing a consumer model that is a scaled down version of their EMS model but none seems to be able to deliver the same bang for the buck that ZOLL has.