by Robert W. Steele, Jr. (Summer 2018)
The push for the increased use of automatic external defibrillators (“AEDs”) in schools, gyms, and other public facilities has grown, with increasing examples of people using AEDs to save the lives of stricken participants. The stories of successful AED use are numerous – from a quick-acting bystander using an AED to save a Naperville theatre patron’s life, to athletic trainer Maddie Biehl’s swift response to high school basketball player Kai Bates-Diop’s cardiac event during practice. Yet across the state a rising concern exists for certain buildings that possess aging AEDs that have not received regular service or replacement.
As early as 2000, the State of Illinois began expanding its laws and regulations on the placement, use, and maintenance of AEDs. One of those laws is the Automated External Defibrillator Act (410 ILCS 4/1 et seq; the “AED Act”), which places a range of requirements on certain facilities, government agencies, and private business owners. Over the years, the AED Act has also continued to mirror federal “Good Samaritan” protections (42 U.S.C. § 238q) by creating explicit exemptions from civil liability. These exemptions mainly cover individuals and entities that train in the use of AEDs, properly trained users, and property owners as well as units of government with AEDs on their premises. 410 ILCS 4/30; see also 745 ILCS 49/12 “Good Samaritan Act”.
Since then, numerous events have shaped public awareness on AED use. In 2008, the tragic passing of a student who collapsed from sudden cardiac arrest during an Illinois high school’s dance practice led to the eventual 2014 signing of House Bill 3724, also known as “Lauren’s Law” into law. Lauren’s Law required elementary and secondary schools to include proper training on AED use in curricula.
With these recent developments, fire protection districts should remain aware of how the AED Act and related laws, regulations, and federal law work together in having an impact on public health and emergency medical services (“EMS”). The AED Act empowers the Illinois Department of Public Health (“IDPH”) to adopt rules on the establishment of programs used to train AED users, identifying accepted courses and requirements for recognition as a trained AED user. In accordance with the AED Act, the IDPH requires data on AED use to be reported to the agency. (410 ILCS 4/25; 77 Ill. Admin. Code 525.500).
The AED Act imposes various duties on anyone obtaining an AED. These duties include taking “reasonable measures” to ensure that the AED is maintained and tested, that anticipated rescuers or users are AED trained, and that the EMS system is activated as soon as possible when “out-of-hospital” AED treatment is given. (410 ILCS 4/20; 77 Ill Admin. Code 525.600). Beyond the AED Act, other laws outline requirements on AED placement and use by trained staff for physical fitness facilities (210 ILCS 74/15), police departments (65 ILCS 5/3-6040), dental offices (225 ILCS 25/44.5), and other entities. Facilities possessing AEDs are required to notify “an agent of the local emergency communications or vehicle dispatch center of the existence, location, and type of the [AED].” (410 ILCS 4/20(b); 77 Ill. Admin. Code § 527.400).
Alongside these concerns is a recent recall on specific models of AEDs. In late 2017, the U.S. Food and Drug Administration (“FDA”) and Phillips Medical Systems, LLC entered a consent decree of permanent injunction against AED producers Philips Medical Systems, Phillips Healthcare, and other parties. The injunction prohibited the manufacturing, processing, packing, holding, or distributing of AEDs from two facilities until Phillips and others comply with federal regulations. U.S. v. Philips North America LLC, et al., Civil Action No. 17-cv-11955. In the consent decree, two facilities were found to be manufacturing “adulterated” emergency care and resuscitation devices (“ERC”) such as HeartStart FRx, HeartStart OnSite, and other AEDs. The Federal Food, Drug, and Cosmetic Act prohibits the production of adulterated medical devices, and a device is considered adulterated if it is prepared, packed, or held in unsanitary conditions, fails to conform with certain performance standards, or violates other portions of the Act. (21 U.S.C. § 351). Consequently, recall notifications for some Phillips’ AEDs have been issued, citing problems with the “self-start” mechanism.
As the Illinois General Assembly recognized in its legislative findings under the AED Act, “timely attention in medical emergencies saves lives,” and AED use by trained individuals “can increase the number of lives saved.” (410 ILCS 4/5). The AED Act and other laws not only assist in services provided by fire protection districts during the minutes between the 911 call and EMS response, but also encourages community involvement in saving lives. Fire districts are in the unique position to promote diligence in checking and servicing AEDs and training users for certification. A district’s awareness of a property owner’s AED location and maintenance, trained staff, and AED use records further ensures that this goal is obtained.