Home medical device safety concerns top 2024 health tech hazard list

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On Jan. 31, nonprofit patient safety organization ECRI released its 17th annual report of the top 10 health technology hazards. Topping this year’s list are home medical devices because they may pose usability challenges for patients and caregivers, risking misuse and patient harm. 

ECRI’s list, compiled from literature reviews, in-house laboratory testing, hospital practice assessments, and investigations of patient safety incidents — plus issues reported to its problem reporting network — can inspire story ideas for journalists covering hospitals, health IT and/or patient safety.

The No. 1 health technology hazard

The use of medical devices in patient homes can support more comfortable and convenient care, but it is not without risk, the authors noted. These devices, which could include blood pressure monitors, implantable devices or ventilators, often are not designed with home users in mind. Patients and lay caregivers may lack the expertise needed to operate them properly. 

“Severe harm can result if patients or their caregivers do not fully understand how to use a device and troubleshoot problems that arise,” they said. Clinicians and institutions should select devices that are well matched to the patient and home environment and provide support that home users need to use the devices successfully. ECRI also challenged device manufacturers to consider home users in their designs, with instructions written for a lay audience and available support for users.

There is a trend toward the use of home health care devices thanks in part to the rapid aging of the U.S. population and decrease in hospital length of stays, said Priyanka Shah, senior project engineer at ECRI, during a Jan. 31 webinar.

“However, the use of these devices also poses unique risks through a combination of factors which include lack of caregiver knowledge over device usability and environmental restrictions,” Shah said, adding that the devices are complex.

Organizations using these devices should provide clear instructions to patients and caregivers on how to use them and troubleshoot problems. And patients and caregivers receiving these devices should always review the directions thoroughly before using them and know who to contact for any questions, Shah explained. 

There also could be space restrictions to the equipment, such as potential electromagnetic interference from teenage children playing video games near patients with implantable devices.

“If the caregiver or user doesn’t know how to troubleshoot the equipment, that can result in serious patient harm or injury,” she said.

ECRI has investigated a number of issues related to medical devices, including one case where patients couldn’t hear an alarm on a child’s ventilator and the child died. In another case, a caregiver misprogrammed an infusion pump and a patient received an incorrect medication dose, Shah explained.

Other health IT-related hazards on this year’s list include:

  • Insufficient governance of AI used in medical technologies risks inappropriate care decisions (#5)
    Artificial intelligence functionality is being incorporated into a wide range of devices and systems in health care. While AI offers the promise to speed up processes and assist in clinical decisions, systems are only as good as the algorithms they use and the data on which they are trained. Shortcomings have been reported of AI functionality contributing to patient harm, performing worse than advertised or providing misleading results. Health care institutions need to establish a robust AI governance program that addresses all phases of technology adoption and use, the authors said. This includes assessing risks and impact on patient care, and monitoring performance after implementation.
  • Ransomware targeting the health care sector remains a critical threat (#6)
    Health care delivery organizations are attractive targets for hackers because of their valued data, critical need to restore operations quickly and often limited resources to protect themselves. During a ransomware attack, hackers may encrypt patient data, extract sensitive information, disable user access or otherwise compromise system operations, which can disrupt the delivery of patient care. While health institutions should implement measures to manage cybersecurity risks, they are “overmatched,” the authors said. “They need help from policymakers and stakeholders” to fend off and respond to ransomware attacks. I have been writing periodically about ransomware attacks for AHCJ, including this most recent post
  • Third-party web analytics software can compromise patient confidentiality (#10)
    Analytics software from outside vendors can provide businesses with valuable statistics and insights about how customers use their websites. However, these tools pose a risk for health care organizations; the software can allow third-party companies such as Meta or Google to collect information that could compromise patient privacy, such as revealing details about their medical conditions. That information then could be used for inappropriate purposes. ECRI recommends health care organizations remove this software from patient portals and “find a doctor” and medical library web pages. I covered this issue in two “How I Did It” posts, including this one.

The remaining items on ECRI’s hazards list are:

  • Inadequate or onerous cleaning instructions for reusable medical devices can endanger patients (#2).
  • Sterile drug compounding without the use of technological safeguards increases the risk of medication errors (#3).
  • Overlooked environmental impacts of patient care endanger public health (#4).
  • Increased burn risk with single-foil electrosurgical return electrodes (#7).
  • Infusion pump damage remains a medication safety concern (#8).
  • Poor quality control of implantable orthopedic products can lead to surgical delays and patient harm (#9).

Some topics are lasting 

The topics on the 2024 list are the ones deemed most pressing by the ECRI authors, but that doesn’t necessarily mean that items cited in previous years have been resolved, said Rob Schluth, principal project officer 1 in device evaluation for ECRI, during the webinar.

For example, hazards related to alarms on physiologic monitoring devices were first mentioned in 2007 and have stayed on the list for many years. It’s still an issue that comes up periodically, he said. 

More recently, cybersecurity and ransomware have become bigger issues and have been covered in about eight of the past years, he said. Health care institutions and journalists can check previous year’s lists for more information. I wrote blog posts (links below) about the 2023 and 2022 lists that journalists can reference.

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Karen Blum

Karen Blum is AHCJ’s health beat leader for health IT. She’s a health and science journalist based in the Baltimore area and has written health IT stories for numerous trade publications.