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AEDs in the workplace: Benefit or burden?

Sudden cardiac arrest is a leading cause of death in the United States, according to the American Heart Association (AHA). And about 10,000 sudden cardiac arrests occur while victims are at work, according to Occupational Safety and Health Administration (OSHA) data.

Placing automated external defibrillators (AEDs) in the workplace, along with providing a proper management system and training for employees on how to use the devices, can mean the difference between life and death, proponents argue. 

But device malfunctions and recalls, myriad legal requirements, and concerns of cost and potential liability have kept some organizations from buying in. 

Of the sudden cardiac arrest deaths that occur each year -- estimates range from 250,000 to 400,000 deaths -- more than 95% of the victims die before they reach the hospital. However, AED advocates note that when care is provided within five to seven minutes, including early treatment with an AED, survival rates can improve dramatically. Local emergency medical services typically can’t respond that quickly.

Using a defibrillator on an individual in cardiac arrest increases his survival rate by 60 percent, according to OSHA. “For every minute that passes without CPR or defibrillation, the chances of a cardiac arrest victim’s survival decrease by up to 10 percent,” OSHA said.

“The bottom line is that AEDs belong in the workplace,” said Larry Starr, director of graduate studies in organizational dynamics at the University of Pennsylvania. Starr’s research primarily concerns systemic characteristics associated with planning for and responding to medical emergencies, particularly involving nonmedical people in the workplace.

“The workplace is the ideal setting because most have a mind-set that includes human resources, risk management and training, and there are policies and accountability expectations,” he told SHRM Online. “Data show that sudden cardiac arrest survival rates can be higher in a workplace than in other locations, including medical institutions, when a workplace makes this topic part of their processes and culture.”

How AEDs work: A scenario

A worker collapses in the office from what may be cardiac arrest.

According to the AHA’s chain-of-survival process, someone should immediately call emergency medical services, and an employee trained in cardiopulmonary resuscitation (CPR) should assess the victim. If the worker shows no breathing and no pulse, the trained employee should start chest compressions and ventilations (i.e., CPR). CPR’s purpose is to deliver oxygen to the blood and to manually pump the oxygenated blood to the brain and other organs. CPR provides basic life support until advanced-life-support providers can take over. However, if the victim is in cardiac arrest, performing CPR will not be enough.

“For a person experiencing a sudden cardiac emergency in which the heart goes into ventricular fibrillation -- a sudden electrically abnormal state -- the only way to try to prevent death, which will occur very quickly, is to use a defibrillator,” said Starr.

A fibrillating heart will not permit adequate circulation even if CPR is performed perfectly, according to the AHA. The only recognized treatment for cardiac arrest is early defibrillation to electrically shock the heart back into a normal rhythm so it can effectively circulate blood. Once the defibrillation pads are applied to the victim’s chest, the AED analyzes the heart rhythm and prompts the rescuer to deliver a shock only when necessary. If either breathing or a heartbeat is present, an AED will not allow the rescuer to shock the victim.

Using electronic voice prompts, the newest generation of AEDs follows three steps. They electronically assess the patient and determine if the reason why no pulse is felt is that the heart has stopped or the rhythm is disorganized. They prepare to release an electric shock that can interrupt the poor rhythm. Finally, they deliver a defibrillating shock only when necessary.

What can go wrong

There are about 2.4 million AEDs hanging on walls and mounted in protective cases in public places across the country, according to the Food and Drug Administration (FDA). Most AEDs reach the end of their expected 5- to 10-year lifetime without ever having been used. Yet they must remain fully charged, functional and ready to operate at a moment’s notice.

The defibrillator industry has recalled hundreds of thousands of devices and has notified the FDA about thousands of adverse-incident reports, including device failure during a rescue attempt that may have contributed to patient harm or death.

Problems include the AED displaying error messages, being unable to power up and failing to deliver shocks.

Problems that can occur -- especially after years of nonuse -- include:

• Software bugs causing error messages or malfunctions;

• Electrodes drying out if not maintained and regularly replaced;

• Malfunctioning resistors, which can lead to misdiagnosis of sudden cardiac arrest;

• Issues with battery management, recharging or accidental discharge;

• Faulty circuit boards;

• Incompatible or damaged cables and connectors; and

• Issues arising from humid conditions.

Since 2005 there have been 45,000 reports of the devices failing or malfunctioning, the FDA reported. The cause in the vast majority of cases was manufacturing problems, officials said, but some problems, like battery failure, were due to improper maintenance. Manufacturers have recalled the devices 88 times since 2005.

In response, the agency issued a proposed order on March 25, 2013, aimed at helping manufacturers improve the quality and reliability of the devices. If finalized, the order would require AED manufacturers to submit premarket approval (PMA) applications.

The proposed review process would allow the agency to more closely monitor how these devices are designed and manufactured.

“Automated external defibrillators save lives,” said William Maisel, deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health. “However, the agency is concerned about the number of recalls and manufacturing problems that have been associated with these devices, and we’re committed to working with manufacturers to address these issues.”

Legal issues, liabilities around AEDs

The purchase and availability of AEDs is controlled by state and federal laws and regulations. As AEDs are considered medical devices, the FDA oversees their manufacture and purchase.

There is no national requirement that employers provide AEDs in the workplace; even so, all 50 states have enacted laws or regulations for the devices. While state laws vary, they generally address AED availability in public buildings, conditions of use, medical oversight, training requirements and postevent reporting. Some states require that schools be equipped with AEDs, while others mandate their availability at health clubs or other fitness facilities.

You can find your state’s AED law here.

Organizations have voiced concerns about liability for using the devices.

In 2000 the federal Cardiac Arrest Survival Act was signed into law; it was designed to expand the availability of AEDs in public settings and provide limited immunity from civil liability to a person who uses or attempts to use an AED on a victim of a perceived medical emergency. Additionally, all 50 states and the District of Columbia now include AED usage as part of their Good Samaritan laws. These laws vary by state but generally protect a bystander from civil liability for voluntarily aiding someone who is injured or ill in an emergency.

“If a workplace is in compliance with public-access defibrillation legislation, and if they provide training defined by their state Good Samaritan law, I would suggest that they are acting not merely in good faith but with proactive intention to save lives,” said Starr.

Moreover, he said that if an employer follows guidelines and approaches for a proper AED workplace program, then it will likely be granted the highest level of protection.

Setting up an AED program

The AHA strongly encourages organizations to implement AED programs to increase the chances of survival of those who suffer sudden cardiac arrest.

All worksites are potential candidates for AED programs because of the possibility of sudden cardiac arrest and the need for timely defibrillation.

Each workplace should assess its own requirements for an AED program as part of its first-aid response. According to OSHA, among the issues to consider in setting up a worksite AED program are physician oversight; compliance with local, state and federal regulations; coordination with local emergency medical services (EMS); the creation of a quality-assurance program; and the performance of periodic reviews.

Key steps to setting up an AED program at your workplace include:

Getting medical oversight. The FDA may require a physician’s prescription to purchase an AED. The physician’s role varies depending on the program’s size and other characteristics. Responsibilities may include signing off on or making recommendations on training plans, policies and procedures; evaluating AED data recorded during an emergency; and helping assess each use of an AED to recommend improvements.

Working with local EMS. Most states require employers to coordinate their AED program with local EMS and to provide follow-up data to EMS after the device is used. In states that require registration or application for AED programs, the physician or program coordinator completes this process.

Choosing an AED. There are several AEDs on the market that are suitable for an organization’s program. The AHA does not recommend a particular one but suggests choosing a simple, easy-to-use device.

Contacting technical support. Make sure you have technical support available when you need it. Call the manufacturer’s technical support number and see what kind of response you get. Is a representative available to help you right away? Are you on hold for a long time? Does your call go to voice mail? Also, be sure to research the manufacturer’s history before purchasing an AED.

Making sure program support is available. Some AED manufacturers provide help with program implementation and ongoing support. They can assist with placement, medical authorization, registration, training and supplies. Review your capabilities and determine if services like these would be helpful in implementing your program.

Placing your AEDs in visible and accessible locations. The media have done stories on people who vainly sought AEDs that were locked away in offices or languishing in unmarked closets. An effective AED response delivers a shock to a victim within three to five minutes after the person collapses. Use a three-minute response time as a guideline to help you determine how many AEDs you need and where to place them. AEDs are commonly located near elevators, cafeterias and main reception areas and on walls in main corridors.

Developing a training plan. AED users should be trained on the device and in CPR. AED training can increase responders’ comfort and confidence level.

Many safety organizations, such as the AHA and the American Red Cross, offer CPR and AED training.

Raising awareness of the program. After implementing an AED program, provide information to all employees about it. You may want to use internal newsletters, magnets, signage or other means to promote the program and identify where the devices are located.

Implementing an ongoing maintenance routine. It is important to visually inspect AEDs weekly or monthly to ensure they are working correctly, the AHA said. This inspection supplements regularly scheduled, more-detailed inspections recommended by the manufacturer. Also, contact the manufacturer periodically to get the latest information about software updates or upgrades.

Roy Maurer is an online editor/manager for SHRM. Follow him on Twitter @SHRMRoy.

©2013 SHRM. All rights reserved.

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MISSING THE FOREST FOR THE

MISSING THE FOREST FOR THE TREES Media reports such as this one, which raise concerns about the safety of automated external defibrillators (AEDs) without recognizing their overarching life-saving value, create confusion and are not in the public’s best interest. Consider this. If 2.4 million AEDs are deployed in public places in the U.S., and there have been 45,000 reports to the FDA of “device failure or malfunction” since 2005, this represents a “device failure or malfunction rate” of less than 2 percent. The true rate is even lower, however, since many of the “device failure or malfunction” reports resulted from routine device self-checks and did not occur during actual use on sudden cardiac arrest (SCA) victims. Further, many reported device failures were actually human failures to properly maintain devices. All told, then, the true “device failure or malfunction” rate is exceedingly low. Further, AEDs do not cause death. Rather, they are used to restore life for people who die suddenly. While they cannot help every victim of sudden death, they at least give many victims a fighting chance. Granted, if AEDs are reclassified as “high-risk” devices requiring time-consuming, expensive regulatory hurdles, the already low “device failure or malfunction rate” could decrease even further, but at what cost? Sudden cardiac arrest affects 1,000 people outside hospitals each day in the U.S. including youth (359,400 cases annually), and only 10% of victims survive. Survival rates increase to 38%, however, when bystanders provide CPR and use AEDs before EMS arrives. If the average survival rate increased from 10% to 38%, as many as 100,000 additional lives could be saved each year. That, of course, would depend on widespread availability of properly maintained AEDs—and increased public awareness about the critical importance of immediate bystander action. The public’s health would be better served if the media focus shifted from “what can go wrong” with AEDs to what goes right for SCA victims when they are treated quickly with these safe and effective lifesaving devices. For more information, visit www.sca-aware.org
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