Administration and Leadership, Columns

Pro Bono: How Equipment Failures Can Impact EMS Agency Liability

Issue 11 and Volume 38.

This month’s issue of JEMS is the annual buyer’s guide, so it’s a good time to give you some tips on how equipment failures can impact EMS agency liability. In this rapidly changing world, driven in great part by technology, it’s often failure to follow “common sense” that gets an EMS agency in legal trouble.

Equipment failures are one of the most obvious adverse events that can happen while caring for a patient that can lead to a negligence action. We’ve had to defend EMS agencies because the defibrillator batteries were dead and the v fib patient died, the suction unit didn’t work and the patient aspirated, or the stretcher failed and the patient’s hip was fractured.

But fortunately, equipment and device failures are also one of the easiest to prevent. An important consideration, too, is to remember that some of the medical devices commonly used in EMS—particularly electronic medical devices—are regulated by federal and sometimes state law. EMS agencies must be familiar with these requirements where they exist as well as the manufacturer’s own recommendation for inspecting and maintaining equipment.

Use Only Approved Equipment and Medical Devices: All equipment and medical devices placed in service must be currently approved by the appropriate federal and state agencies. Federal agencies such as the Food and Drug Administration (FDA) and, in some cases, state EMS agencies, oversee the use of medical devices. Make sure the medical device you use has all the necessary approvals. The device may be approved for general medical use by the FDA, but your state EMS regulations may dictate what devices you can and cannot place into service. Your local or regional medical director may also have the ultimate say on what medical devices can be used by your EMS agency. And while medical devices can’t be placed on the market until they’re approved by the appropriate agency, often there are recalls and product alerts that you must keep up with, similar to the recall notices issued by vehicle manufacturers.

Maintain Your Equipment: Medical devices, such as cardiac monitor/defibrillator units, require regular inspection and maintenance. There are specific standards for the periodic testing of electronic medical devices, such as cardiac monitor/defibrillators, that must be followed. Medical devices must be properly inspected in accordance with government requirements, manufacturer recommendations and by qualified experts. If the device fails, and a patient is harmed as a result of that failure, and it’s shown that the device was not properly maintained in accordance with FDA requirements or manufacturer’s recommendations, there will almost certainly be liability attributed to the EMS agency.

Check Your Equipment Every Shift and After Every Use: EMS agencies need clear policies on equipment inspection. Essential medical equipment and devices must be completed on every shift and after every use. These policies must require accurate completion of a checklist to document that the equipment was, in fact, actually checked to make sure it was working properly. If equipment fails and a patient is harmed, one of the first discovery requests in the lawsuit will be to obtain the agency’s policies on equipment checks—as well as the actual checklists performed on the day of the incident that led to the harm and over a period time prior to and after the event. Don’t be caught with no policies or no checklists. Supervisors and officers need to emphasize the importance of checking equipment and call people out when they don’t check it. This is a common area where EMS providers get “lazy” and use the improper excuse, “Well, they didn’t use it on the last shift, so it must okay.” EMS agencies cannot tolerate this sloppiness. The public expects that equipment will be regularly checked and that it will actually work properly when used on them or their loved ones. That’s not too much to expect of a professional EMS agency, so failure to meet this fundamental expectation will certainly lead to litigation.

Protect the Evidence When Failures Occur: A common mistake made when equipment or devices fail (especially stretcher and cardiac equipment)—and the failure harms the patient—is to have the EMS agency’s own maintenance personnel inspect and fix the equipment. This can hurt your defense of a negligence action if there was a defect in the product that was the fault of the manufacturer and not the EMS agency. The manufacturer can then say that the device wasn’t the problem as there can be no proof of product failure if your agency “tampered with” the device. The best approach is to take the equipment/device completely out of service, secure it from tampering by anyone (lock it up) and then call your legal counsel. Your counsel may want to secure an independent expert to inspect the failed device and issue a report. Be wary of the manufacturer’s offer to take the device back for inspection and repair. Any defect in the product may be difficult to prove later.

Don’t Over-rely on Technology: Recent reports reveal that airline pilots may be relying too much on computers to fly the plane and are forgetting the “stick and rudder” basics of flying during a crisis. We are also immersed in technology in performing our jobs that helps us to more accurately and rapidly diagnose and treat patients. This technology has made the work of an EMS provider easier, but we can sometimes rely too much on what these devices are telling us. We must look at the patient just as much as we look at that cardiac monitor! Nothing can take the place of a thorough hands-on patient assessment by an experienced EMS provider. We need to be “high tech” in today’s EMS environment, but we also have to be “high touch.” Devices fail, and as long as the EMS provider doesn’t let these valuable tools take priority over basic assessment and treatment skills, the patient will be well served.