Bringing Medical Technology Hazards to Light

When it comes to the medical devices you are producing, where are the potential pain points when the technology reaches the hospital, doctor’s office, or patient’s home? Sometimes, that answer isn’t so easy to see until the product is already being used in the real world. It passed FDA muster and it’s been accepted by the healthcare industry, but there is a concerning aspect that was missed during development. 

Enter ECRI. The nonprofit organization is dedicated to uncovering medical device issues and concerns. As an independent medical device testing laboratory, it is designated as both an Evidence-based Practice Center and Patient Safety Organization. According to its website, “ECRI conducts hands-on rigorous testing and evaluation of devices that informs real-world technology decision making across all care settings.”

Each year, the organization publishes its Top 10 Health Technology Hazards for 2025. Last year, Mike Drues and I discussed that list on the Medtech Matters podcast. For those who may have missed it, I decided to bring my brief comments to this format for this year’s list. (While I share the full list here, I don’t have comments on all items. I encourage you to get ECRI’s brief to review their comments on each list item: tinyurl.com/mpo250199).

1. Risks with AI-Enabled Health Technologies—Artificial intelligence holds significant potential for healthcare. In some areas, such as imaging diagnostics, it’s already making its mark as a way to enhance standard processes and make detection more efficient. But the technology is very much in its infancy. Relying too heavily on it or having unrealistic expectations of its performance is a potential issue. Simply, as ECRI put it, “Placing too much trust in an AI model—and failing to appropriately scrutinize its output—may lead to inappropriate patient care decisions.” Also, while we’re here, stop saying your solution is AI-based just because it has software in it. Investors are catching on to this gimmick. 
2. Unmet Technology Support Needs for Home Care Patients—Human factors design is so important, FDA has issued guidance regarding it. I submit it’s an even more important factor with home care devices. Patients are not doctors and are not likely familiar with technologies found in the hospital. As such, don’t design your home device the same way. You must develop a home care device for the layman user, not the healthcare professional. Further, offering tutorial videos, a user-support hotline, or other methods with which to inform users would be a tremendous help. 
3. Vulnerable Technology Vendors and Cybersecurity Threats—I’ve been ringing this bell for years, so seeing this on the list isn’t a surprise. I first thought it was troublesome that it wasn’t #1, but then again, perhaps device makers are finally heeding the call and it’s down to this spot. Regardless, it’s clearly still an issue and one that needs your attention for your connected devices today. See our Cybersecurity column that runs in every issue for key insights. 
4. Substandard or Fraudulent Medical Devices and Supplies—While attending Medica last year, I encountered a woman who is involved in this topic. We’re seeking an article from her for a future issue, so stay tuned for that. In the meantime, speak with your packaging suppliers and device designers to get ideas on how to address this issue. The harder it is to replicate your products, the better it will be for your customers and their patients. 
5. Fire Risk in Areas Where Supplemental Oxygen Is in Use
6. Dangerously Low Default Alarm Limits on Anesthesia Units
7. Mishandled Temporary Holds on Medication Orders
8. Infection Risks and Tripping Hazards from Poorly Managed Infusion Lines—While this seems like a hospital-centric issue, is there a design solution for it? Would a mechanism similar to the way the power cord returns into an iron work here too? Would it help eliminate excess tubing laying across the floor, creating the tripping hazard? As the device maker, can you proactively provide a solution?
9. Skin Injuries from Medical Adhesive Products—No one likes ripping the Band-Aid off, but when sensitive skin is involved (e.g., elderly patients, infants, or those with open sores), the issue is much more serious. No doubt, my trip to MD&M West in early February will present me an opportunity to speak with adhesives suppliers about the latest offerings they are developing to resolve these issues. (MPO is at booth 1793; stop by and say hello.)
10. Incomplete Investigations of Infusion System Incidents

What didn’t make the list? Are there device challenges you see in the healthcare environment you are trying to address through your own product development? As always, I welcome your feedback and thoughts, and hope to see you in Anaheim.

Sean Fenske, Editor-in-Chief

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