Device Modifications: An End-User’s View

Our patient-care institutions depend on medical instrumentation to safely monitor and treat our patient populations. During the selection process, we evaluate these devices on their ability to accurately treat or diagnose our patients in accordance with the manufacturer’s design. We also depend on our clinical engineering staff to ensure that the equipment is safe, effective, and operational within the manufacturer’s designed parameters. We do this by scheduling preventive maintenance and responding to repairs as part of our jobs. We sometimes even go as far as modifying medical equipment for clinical or safety reasons.

During this year’s Association for the Advancement of Medical Instrumentation conference in Tampa, Fla, the subject of equipment modification was brought up on more than one occasion. The views ranged from “Absolutely no way” to “It’s my stuff, and I’ll do what I want” and, finally, to “I hope I don’t get caught.” Well, now it’s time to discuss this issue between the No-Mods, Pro-Mods, and What-Mods. Oh, yes, let’s not forget other influences that should enhance this discussion: our patients, our medical centers, the manufacturers, and the Food and Drug Administration (FDA).

Let’s say that you are approached by the respiratory therapist (RT) from neonatal asking for your help in setting up a ventilator so it can deliver helium to an infant patient. It seemed that this was a very promising treatment that had been successful at other institutions with these small critical patients. You collaborate with the RT and the neonatologist and determine that by supplying HeO2 gas to the air side of the ventilator, you can achieve the desired results and still be able to monitor the oxygen levels. But alas, this would require ... modifications.

Let’s say that you bring up this issue with the clinical staff. They don’t care—your modification is a brilliant solution to their immediate problem. You then continue to your manager with this request. First of all, are you in-house or under contract for your services to the medical center? Hmmm. ... It seems that a possible legal situation could develop out of this. You may have to run this by the risk-management department. But which one—your company’s or the hospital’s?

You decide to contact the manufacturer to see if your modification will indeed work. You soon find that they don’t know you, your hospital, or even what equipment you’re talking about. The only person they know at this time is someone called FDA.

You call the FDA to get some advice and are asked if you are the manufacturer of the device. You say that you are the end-user and need to perform this modification to help save a small life. The FDA then explains, in time-stopping detail, several reasons why you can and cannot perform this modification and that, ultimately, you can end up in litigation and sanctions if an adverse event occurs as a result of your actions. Somewhere in this conversation, you determine that the FDA does not have the resources to check all equipment in medical centers to see if they’ve ever been modified. You rush back to the neonatal intensive care unit and set up your vent for HeO2 gas delivery. Bottles are brought up, treatment begins, and the prognosis is is better than expected; soon afterward, the parents take the newborn home. You break down your setup, return all the equipment back to normal, and ponder your actions. You then recall that many patient deaths have occurred due to hypoxic gas mixtures from adapting gas connections and realize that one misstep on your part could have ended in this result.

There will always be cases where a little design and fabrication will result in a desired clinical outcome, but modification is not the complete answer. We now must consider adapting equipment with networks, information technology, wireless, and remote alarms—and believe me, it’s not plug and play. By changing the device’s function and design, we become the person who’s solely responsible for its safe operation, and we will need assistance from the vendor to adapt to these new clinical information systems. We need to establish proper procedures and rules in our hospitals, and consult the FDA on how far we can step over the line in these rare cases. The intent of equipment modification is to provide positive solutions in delivering health care, but this tool must be handled very carefully and with forethought. Remember: Measure twice, cut once. 24x7

David Stiles, CBET, is supervisor of biomedical engineering at Long Beach Memorial Medical Center, Long Beach, Calif.