By Andrew Whyte
When is it time to just let go of an aging medical device? When do we finally push the Narkomed into the dumpster, quietly shuffle that Eagle 10 into the scrap metal bin, or pry the CodeMaster XL from the bony hands of the cardiologist who has had it for nearly 30 years? Yes, I know it can still shock, Doc, but it crackles and the lights dim when you press the charge button.
I’ll admit it; I have kept many pieces of equipment going far longer than is reasonable. In fact, I take a certain amount of pride in keeping old equipment operational. But eventually, we have to draw the line somewhere … right?
So, what could, or perhaps more importantly, what should stop us from continuing to support aging medical devices? Government direction might be a good place to start. A risk assessment certainly has a role to play. The availability of parts, environmental concerns, new technology and features and, of course, the budget. We all know that cash is king, so maybe it really is all about the money.
Government Direction and the FDA’s AED List
Every few months, I take a peek at the FDA’s list of approved AEDs. I know, right? What fun! It is a fairly easy web search to find if you’ve never taken a look. Models are in fact added and removed from time to time. Plenty of devices have been subject to voluntary recalls, and we have also seen government interventions when equipment goes really bad. Some of us may remember when a certain infusion pump manufacturer accumulated so many recalls that it was eventually banned from selling its products for a period of time. I started with the FDA’s list of AEDs for a reason. When a department has an AED that is so old that even I don’t want to put my name on it, I hand the department a copy of that list. The office manager is usually off ordering a replacement within minutes, and I’m not the bad guy.
Now, the FDA does not say to throw out an unapproved AED immediately. In fact, its guidance states: “Continue to keep your AED available for use, even if it is not FDA-approved, until you obtain an FDA-approved AED, given the importance of these devices in emergency situations.” Sometimes all it takes is an authoritative source to move a replacement from the “someday” list to the “we need to order this now” list.
The Almighty Risk Assessment
Every hospital system I have visited has its own version of a medical device risk assessment. Ours is an amalgamation of four different assessments, and so far, so good. Most forms have a box asking some variation of “Do we have a backup if this device breaks?” Consider a nursing unit with a fleet of infusion pumps. If one pump breaks, it may not be a big deal. At least, it’s not a big deal to us until we get paged at 2 a.m. on a Sunday. That situation might receive a relatively low score in the backup category of my risk assessment. Now compare that with a small cardiology office that has a single stress-test system. That is a very different situation. A single point of failure can become a linchpin for a whole collection of headaches. You know how long it takes to get a treadmill tilt motor? I do, and it’s too long.
I am far more likely to tell the cardiology office that it is time to replace that 10-year-old stress-test system than I am to tell a hospital that it needs to replace an entire fleet of infusion pumps. Then again, if those pumps are approaching the same age, the hospital should probably at least start looking at replacement options.
The point is that the age of the device alone does not determine the risk. How critical the device is, whether a backup exists, how frequently it is used and what happens when it fails all matter.
Can We Still Get Parts for Aging Equipment?
Can you even get parts for that device when it arrives in your shop? Is the only remaining example of the centrifuge you are working on sitting in a museum? Go ahead and buy new brushes for it. You can file them down to fit. What makes me throw in the towel most often is the unavailability of parts. Overlays, hard drives, lenses, glass components that look hand-blown. These are the things that usually bring a repair to an end. Funny enough, though, batteries never seem to be a problem.
Anecdotally, some parts have become more available as equipment gets retired. By the magic of buying a second device on your preferred auction website, we suddenly have a supply of parts for equipment that has been discontinued for years.
Then there are those newfangled 3D printers. Sometimes, they can produce the little doodad that keeps the whatchamacallit going. Years ago, an electrocardiograph arrived in our shop from a rural health clinic. The unit was already old then, and its end-of-life letter was yellowing in the filing cabinet. The rubber mounts for the print motor were failing. The solution back then was to just stick a piece of wood under the motor, prop it up and call it a day. Nearly a decade and a half later, that same unit showed up in my shop again. A quick model in AutoCAD, about 50 cents’ worth of plastic later and we had a perfectly sized cradle. No more wood! Can we still get paper for the unit? Yup. Batteries? Yup. The button overlay? Oh, Lord no. We’ll likely be saying goodbye to that ECG if it ever comes back for anything other than a battery replacement.
Environment and General Safety
We also have to consider the risk of keeping old and ancient equipment. Hospitals are often described as some of the most dangerous places to work, and older medical equipment can contribute to that risk. Take mercury blood-pressure gauges, for example. Does your hospital have any hanging around? I hope not, but I still see them from time to time. Then there are sterilizers containing asbestos insulation. There are a variety of older devices that present hazards that were either unknown, poorly understood or simply accepted when the equipment was new.
MedWrench Can Help
Can that handsome guru on MedWrench help me keep this device going?
Alright, well, yes, most of the time, but even I have had to tell some users the bad news. When the last service manual in existence was scanned at a slant in 1997. When the ultrasound has a monochrome CRT and you need a new hard drive. When the film canister on your X-ray system isn’t turning right. It’s time to let go. I still have the image file for the PageWrite XLI if anyone needs that though. That is, if you still have a floppy drive.
So, When Do We Let Go of Aging Medical Devices?
There probably isn’t a single magic number that tells us when a medical device has reached the end of its useful life. OK, sometimes there is, but 10 years is not automatically too old, just as five years does not automatically mean it’s still supported. The better question is whether the device can still perform its intended function safely and reliably, and whether we can reasonably support it when it fails. Regulatory status, risk, redundancy, parts availability, safety, environmental concerns, technology and cost all play into it.
And perhaps the hardest part for those of us who maintain medical equipment is knowing when our ingenuity is extending the useful life of a device and when it is merely postponing an inevitable decision. (I’m getting Old Yeller vibes here.) There is nothing wrong with being proud of keeping an older device alive. But eventually, even the most dependable old equipment deserves a dignified retirement, and sometimes the best repair decision we can make is knowing when not to repair it.
MedWrench Guru Andrew Whyte, CBET, is the owner and operator at Maple Tree Biomedical. He began his biomed career in the U.S. military and has more than a decade of HTM experience.
