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Medical devices for the home top list of health tech hazards for 2024


ECRI, the patient safety organization, released its annual list of 10 technology trouble spots. Marcus Schabacker, CEO of ECRI, talks with us about taking steps to protect patients.

More health systems and hospitals are looking to expand options to care for patients at home, but a new report points to some obstacles that threaten the safety of patients.

ECRI, a nonprofit organization focused on patient safety, released its annual list of the 10 leading healthcare technology hazards Wednesday. Safety challenges involving medical devices at home topped the 2024 list of technology trouble spots. ECRI also cites other challenges, including poor instruction in cleaning medical devices, sterile drug compounding, the insufficient governance of artificial intelligence in healthcare, and cybersecurity.

But the concerns over the use of medical devices at home rose above all others.

To be clear, the group acknowledges the value of medical devices in the home and the benefits for patient care. However, ECRI says the devices often have complex instructions that can be difficult for patients and caregivers.

Marcus Schabacker, MD, president and CEO of ECRI, talked with Chief Healthcare Executive® about the potential hazards in patients using medical devices and tools at home.

With more healthcare shifting to the home, “medical device manufacturers are woefully unprepared for that,” Schabacker says. (See part of our conversation in this video. The story continues below.)

Schabacker likens the situation to asking someone off the street to try to compete in Formula One racing.

“If you put me in a Formula One race car, I wouldn't get around the first corner,” Schabacker says. “And that's what we're trying to do, what we're doing to patients and their caregivers, lay caregivers, at home. We’re giving them the equivalent of a Formula One race car, which is the highly sophisticated medical device, being an IV infusion pump, a ventilator, dialysis machine, they have no training or education in how to use.”

Patients and caregivers also typically lack the understanding in resolving a problem they’re having with the device, such as an alarm going off at 11 p.m., “because they didn't have the medical and or technical training,” Schabacker says.

He points to the rigorous process involved in bringing medical devices in hospitals, which typically includes extensive training for doctors, nurses and other staff, often repeated at regular intervals.

“None of that is happening at the home,” Schabacker says. “So we’re putting a Formula One race car in the hands of an everyday driver, and expecting them to be sufficient in the usage and the troubleshooting and the interpretation of what they see, which is just unrealistic.

“And so that's where we see the main concern, is that industry and providers are way behind what the reality looks like today.”

Health systems and providers are typically going over instructions of devices, but a quick overview may not be sufficient for patients who may be overwhelmed, as patients tend to be when they are grappling with a serious health condition. Medical devices can be especially perplexing for patients who may be living alone and don’t have a loved one to help with usage or troubleshooting.

Schabacker also calls on providers to offer the best training possible, and he urges the healthcare industry to develop instructions on medical devices that are simple for patients to understand.

“A lot of these instructions for use, they are written for expert users,” Schabacker says. “So the call to industry is, make it simple. Make it understandable for a layperson. Don't use medical terminology, use lay technology. Give clear guidance. Here's a telephone number, you can call when you are at home.”

The second leading hazard on ECRI’s list focuses on inadequate instructions for healthcare providers in cleaning reusable medical devices. Schabacker says this has been a persistent concern. Some instructions are often too complex or impractical.

“This is where industry is just detached from reality,” Schabacker says. “And they are designing a product with what is feasible for them, not understanding the human factor process of it, the human interaction, the clinical workflows, the processes in the hospital on how this is used on a day-to-day basis. And then recommending things which are either very complicated and onerous, so people just don't do it.”

Schabacker urges the healthcare industry to think about the human factor in developing medical devices and in their guidance to professionals. He encourages manufacturers to understand the clinical processes “and the human factor aspects of those clinical processes where the failures occur or potentially can occur, and then design safety features into your products.”

Health systems and providers should focus on a goal of “zero preventable harm,” he says.

He points to some key areas to improve safety, including a safety culture set by leadership, an active learning system, and the need to include patients and caregivers in the safety process.

Finally, Schabacker encourages hospitals and other providers to create a good environment for staff, and he says that goes beyond clinicians.

Providers and clinicians should create “a no shame, no blame culture, to identify issues, bring them up and then put them into the learning system, so that everybody can participate in and gain insights from it,” Schabacker says.

Here’s the full list of ECRI’s top 10 health technology hazards this year.

1. Medical devices posing challenges to home users that could harm patients

2. Inadequate or difficult instructions in cleaning medical devices

3. Sterile drug compounding without technological safeguards, which could lead to medication errors

4. Overlooked environmental impacts of healthcare

5. Insufficient governance of AI in medical technologies

6. Ransomware aimed at the health sector

7. Increased burn risk with single-foil electrosurgical return electrodes

8. Infusion pump damage remains a medication safety concern

9. Poor quality control of implantable orthopedic products, which can delay surgeries and hurt patients

10. Third-party web analytics software can threaten patient privacy

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