The recent failure of cheap knock-off tourniquets made in China drew attention to the importance of the equipment we rely on every day—from the large and expensive things like a monitor/defibrillator to the small and less expensive (but equally important) items like tourniquets. We assume the products and devices we use will never fail, but on occasion they do.
Failure of critical equipment can harm the patient and even result in death. And that can bring about a negligence lawsuit and products liability action. Product liability actions against the manufacturer are based on manufacturing defects, design defects and failure to warn the consumer as to proper use and known limitations, also known as a “marketing defect.”
EMS agencies can also be liable under general negligence principles for using defective products. In fact, many lawsuits brought by patients when harm results from an equipment failure start as general liability cases against the healthcare provider who used it. The product manufacturer is typically brought into the lawsuit later, if the defect wasn’t obvious to the patient at the time of the lawsuit.
In this “global economy” where products are designed and manufactured all over the world, EMS agencies need to take extra precaution to ensure that all equipment they use is high-quality equipment and used in the manner it was intended. Here are 10 tips for avoiding harm to the patient—and litigation—from a defective product:
1. Purchase only quality products. Do your research, make comparisons, and investigate the company and the process they use to design and manufacture their products. Be wary of purchasing medical products through third parties unless they’re authorized dealers. Read product reviews. A simple Web search will reap many comments from other healthcare providers who’ve had first-hand experience with the product and can provide insight into the pros, cons and reliability.
2. Test the product. Before you commit to buying a large supply, buy one and test it out, or request one from the manufacturer to try out. If the manufacturer or dealer is interested in a big sale, they may be inclined to let you put their product “through the ropes” before you commit to a large purchase.
3. Check the warranty. Buy only equipment with a solid warranty. Read the warranty carefully for exceptions and limitations and do nothing with the product that could arguably be seen as voiding the warranty.
4. Use it only as directed. A common phrase in healthcare, but it’s so true. You should study the manufacturer’s instructions to make sure you use the product as intended. Don’t stress it to the limits or use it improperly. Don’t modify the device or try to improve it. We’ve seen that done with oxygen regulators by adding valves and extra devices. That could not only void the warranty, it could also harm the patient and be a defense for the manufacturer in a lawsuit.
5. Maintain it. Follow the manufacturer’s recommendation for maintenance and stick to it. Failure to do so can result in failure that can harm the patient and can provide a defense to the manufacturer in a lawsuit. Some equipment can be maintained by your own staff, but sophisticated equipment like electronic medical devices must be strictly maintained by authorized service personnel to ensure compliance with federal and state law. All equipment should be properly checked by on-duty crews at the start of the shift, and checklists should be maintained to verify that the equipment was checked and that it’s part of your regular business practices to do so.
6. If it breaks, don’t scream and yell! If the device fails while treating a patient, you shouldn’t jump up and down and bring attention to the failure. That’s like waving a red flag to the patient and family that says, “Sue us!” It’s better to stay calm, treat the patient as best you can, and deal with the equipment failure after the call.
7. Report the failure immediately and document it. Promptly notify your supervisor and get instructions on what to do. Never use equipment you know is faulty, not functioning or is ready to fail. That means you now have knowledge of the defect, yet used it anyway. If an untoward event occurs, that adds fuel to the negligence lawsuit against you. Document all particulars of the failure in great detail. Create this documentation with an agency-approved incident report form, and keep that report separate from the patient care report so it doesn’t become part of the patient record.
8. Secure the broken equipment. If the failed device played a role in harm to the patient, it should be immediately taken out of service and secured to prevent any tampering. It may now be evidence and it should be treated that way. Your agency should have procedures on securing the faulty equipment, including taking pictures and making sure there’s a clear chain of custody of it. This is critically important if the failure resulted in harm to the patient. Avoid the temptation to throw it out—like with an inexpensive item such as a tourniquet—or the temptation to immediately send it back to the manufacturer or respond to the manufacturer’s offer to let their experts look at it and repair it. That could destroy evidence of the defect and, along with it, an important defense if you get sued.
9. Don’t attempt to repair it yourself. We love to fix things; it’s the nature of our work as EMS professionals! But don’t let ego get in the way. Unless it’s clearly authorized to initiate a repair in a manner that doesn’t destroy evidence or void the warranty, in-house repairs shouldn’t be attempted.
10. Contact legal counsel immediately. Of course we saved the best for last! It’s absolutely essential that you contact legal counsel right away in any situation where a patient was injured in the course of transport or treatment, especially when a product failure may be the root cause of the harm.
We all want to work with products that are of high quality, especially when lives are at stake and the patient could be harmed by a device that’s improperly used or fails to work. Common sense in purchasing and maintaining your medical equipment can prevent a disaster for you, your EMS agency and, most importantly, the patient.
Pro Bono is written by Steve Wirth, Esq., EMT-P, andDoug Wolfberg, Esq., attorneys and founding partners of Page, Wolfberg & Wirth, The National EMS Industry Law Firm. Visit the firm’s website at www.pwwemslaw.com.