What You Should Know:
– ECRI, an independent healthcare safety organization, has released its annual Top 10 Health Technology Hazards list for 2024, highlighting critical safety concerns for healthcare providers and the medical device industry.
– This year’s list focuses on a diverse range of issues, from usability challenges of home medical devices to environmental impacts of patient care and the dangers of ransomware attacks.
Top 10 Health Technology Hazards for 2024
Here’s a closer look at the top 10 health technology hazards identified by ECRI:
1. Medical Devices May Pose Usability Challenges for Home Users, Risking Misuse and Patient Harm
ECRI challenges manufacturers of devices that may be used in the home to consider the needs of users in this setting. Device operation should be intuitive, instructions should be written for a lay audience, and user support should be available.
2. Inadequate or Onerous Device Cleaning Instructions Endanger Patients
ECRI challenges manufacturers of reusable medical devices and healthcare items to provide practical, validated reprocessing instructions for their products. These instructions should adhere to relevant FDA guidance and should involve the use of common healthcare cleaning products.
3. Sterile Drug Compounding without the Use of Technological Safeguards Increases the Risk of Medication Errors
Both ECRI and the Institute for Safe Medication Practices (ISMP) recommend that pharmacy departments implement technological safeguards—like workflow management systems— to minimize opportunities for human error in the sterile compounding process. These systems offer a range of capabilities (e.g., bar coding, gravimetric analysis) both to help prevent errors during the manual steps in the process and to help catch errors before they reach the patient.
4. Overlook Environmental Impacts of Patient Care Endanger Public Health
ECRI challenges medical device manufacturers to design products with sustainability in mind— for example, by reducing the use of materials that contribute to environmental harm, by making reusable products easier to clean using minimally damaging processes, and by minimizing waste material (e.g., packaging) included with each product.
5. Insufficient Governance of AI Used in Medical Technologies Risks Inappropriate Care Decisions
AI offers the promise of speeding up processes and assisting in clinical decisions. But AI systems are only as good as the algorithms they use and the data on which they are trained. Shortcomings in either area can lead to inappropriate responses. Instances have been reported of AI functionality contributing to harm, performing worse than advertised, or providing misleading results
6. Ransomware Targeting the Healthcare Sector Remains a Critical Threat
Healthcare delivery organizations (HDOs) are attractive targets because of the value of their data, their critical need to restore operations quickly, and (often) their limited resources for hardening defenses. . HDOs need broad support to fend off and, when necessary, respond to ransomware attacks. Areas for policymakers to consider include incentives for implementing strong security programs, as well as HDOs’ wherewithal to do so (in terms of funding and staffing); law enforcement tools for disrupting criminal networks; and the unintended consequences of existing penalty structures for being victimized by a ransomware attack.
7. Increased Burn Risk with Single-Foil Electrosurgical Return Electrodes
ECRI challenges return electrode manufacturers to cease the manufacture and sale of single-foil conductive return electrodes, particularly for adult patients.
8. Infusion Pump Damage Remains a Medication Safety Concern
ECRI challenges manufacturers to advance the technology by designing models that, for example, have fewer damage-prone components, can more reliably prevent gravity flow, and are made from materials that can withstand cleaning with a greater variety of chemicals. Further, we encourage manufacturers to simplify cleaning steps and develop means to help users adhere to validated cleaning and disinfection methods.
9. Poor QC of Implantable Orthopedic Products Can Lead to Surgical Delays and Patient Harm
ECRI challenges manufacturers of implantable orthopedic products—and all single-use medical devices—to strive for zero defects in their manufacturing and packaging processes.
10. Third-Party Web Analytics Software Can Compromise Patient Confidentiality
ECRI recommends that healthcare organizations remove third-party web analytics software from patient portals, as well as from “find a doctor” and medical library pages. In ECRI’s view: Patients expect a provider’s website to be a confidential safe haven for seeking medical information, treatment, and services. The collection and potential exploitation of private information could lead to patient distrust of the healthcare provider.
A Call to Action for Industry and Healthcare Providers
ECRI’s list serves as a critical reminder of the potential dangers lurking within seemingly innocuous medical technologies. It’s a call to action for both the healthcare industry and healthcare providers to:
- Prioritize patient safety: Implement robust risk management strategies, invest in safer technologies, and ensure proper training and education for all personnel.
- Embrace innovation responsibly: Develop and utilize AI technologies in a safe and ethical manner, ensuring transparency and accountability.
- Collaborate for better solutions: Work together across industry lines and with regulatory bodies to identify and address emerging threats, share best practices, and develop safer medical technologies.
By acknowledging and actively addressing these hazards, healthcare providers and the medical device industry can work towards creating a safer environment for patients and healthcare professionals alike.
“With each advance in technology, cybercriminals sharpen their tools. Ransomware attacks can cripple hospital operations, delay diagnoses, and endanger lives. We can’t afford to treat cybersecurity as an afterthought. We need adaptive, cutting-edge solutions to remain operational and prevent these disruptions before they become critical emergencies,” said Eddie Myers, the National Director of Cybersecurity at Crothall’s Healthcare Technology Solutions division.
