By ECRI
Providing safe and effective patient care requires identifying sources of danger or difficulty with health technologies and taking steps to reduce the risk of harm. ECRI produces its annual Top 10 Health Technology Hazards report to help in this effort. The full report, accessible to ECRI members, highlights key technology management challenges and provides detailed recommendations to prevent adverse incidents. For non-members, an Executive Brief is available for complimentary download at www.ecri.org/2024hazards.
ECRI identified the following topics as warranting high-priority attention in 2024.
1. Usability Challenges with Medical Devices Used in the Home
The trend toward providing health care in the home has led to the increased use of medical devices in that setting – including devices intended for use in a clinical environment (e.g., infusion pumps, ventilators). However, not all devices are sufficiently intuitive for home users to operate. Plus, the home setting can introduce environmental limitations (e.g., space restrictions, power issues) that impact device operation.
Severe harm can result if patients or their caregivers do not fully understand how to use a device and how to troubleshoot problems that arise. ECRI has encountered numerous examples of patient harm in this setting, including fatalities when a ventilator alarm failed to activate, and when a venous needle became dislodged during hemodialysis.
To minimize the risk of harm: Manufacturers should consider the needs of users when designing their devices that may be used in the home, and providers should select devices that are well matched to the patient and the environment of use, and provide the support that home users need.
2. Inadequate or Onerous Device Cleaning Instructions
Failure to properly clean and disinfect or sterilize reusable medical devices can lead to the spread of infection, device damage, and other forms of harm. Successful reprocessing is made more challenging, however, by the wide variation in the content, quality, and feasibility of reprocessing instructions. This puts patients at risk, as well as staff, who may suffer injuries from repeatedly performing onerous reprocessing steps.
ECRI recommends that health care organizations assess reprocessing considerations before purchasing reusable health care items. Favor products from vendors that provide practical, validated reprocessing instructions.
3. Sterile Drug Compounding without the Use of Technological Safeguards
Errors made when compounding injectable medications can have severe – sometimes deadly – consequences. Unfortunately, errors such as using incorrect ingredients or drug concentration are exceedingly difficult to detect once the preparation leaves the pharmacy.
While accurate compounding is important for all preparations, injectable preparations are of particular concern because of their need to be sterile, the frequency with which compounding is required, the opportunities for error, and the potential for significant harm. The use of technological safeguards, such as workflow management systems, can help minimize opportunities for human error.
4. Overlooked Environmental Impacts of Patient Care
Medical technologies play a lifesaving role in patient care, but their manufacture, use and disposal have a cost. These activities consume energy, release contaminants, and generate waste, adversely impacting the environment. This creates public health challenges – causing or worsening myriad health problems – and it exacerbates health inequities, since many of the health risks associated with environmental stressors disproportionately impact disadvantaged communities.
As protectors of public health, health care organizations should examine ways to minimize environmental harm. The challenge is to do so without compromising patient care. Sensible strategies include reducing energy consumption in the imaging suite, choosing alternatives to the most harmful anesthetic gases, and eliminating purchases of extraneous single-use items (i.e., those that will be thrown away without being used).
5. Insufficient Governance of AI Used in Medical Technologies
Artificial intelligence (AI) functionality is being incorporated into a range of health care devices and systems – from workflow aids (e.g., automated scheduling software) to diagnostic support systems that interpret medical images or analyze a patient’s medical record. 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.
Instances have been reported of AI functionality contributing to harm, performing worse than advertised or providing misleading results. To manage this emerging technology, health care institutions need to establish an AI governance program that addresses all phases of technology adoption and use, from pre-implementation assessment to post-implementation monitoring.
6. Ransomware Targeting the Health Care Sector
Health care organizations are attractive targets to hackers seeking to infiltrate IT networks (to extract a ransom payment) because of the value of their data, their critical need to restore operations quickly, and their limited resources for hardening defenses. Organizations need to implement measures to manage cybersecurity risks; but these measures aren’t foolproof, and many providers are overmatched.
Health care organizations need help from policymakers – for example, to address shortfalls in cybersecurity funding and expertise, to reassess penalty structures for being victimized by an attack, and to strengthen law enforcement efforts at disrupting hacker networks.
7. Increased Burn Risk with Single-Foil Electrosurgical Return Electrodes
Adult patients are placed at unnecessary risk of burns during electrosurgery when single-foil conductive return electrodes are used instead of safer options. Single-foil electrodes do not engage an electrosurgical unit’s return electrode contact-quality monitor – a safety feature designed to detect when contact between a return electrode and the patient is compromised. When electrosurgery-related burns occur, insufficient contact between the return electrode and patient is a common cause. Safer alternatives include the use of dual-foil conductive return electrodes, capacitive return electrodes or other treatment modalities.
8. Infusion Pump Damage – An Ongoing Medication Safety Concern
Infusion pumps are routinely subjected to conditions that can lead to damage, whether through mishandling, exposure to cleaning chemicals, or normal wear and tear. Such damage can affect the pump’s ability to accurately deliver fluids or medications, leading to dangerous medication administration errors. Furthermore, if the damage goes unnoticed or uncorrected, multiple patients can be put at risk. ECRI investigated one incident in which the absence of a key pump component (one that helps regulate the flow of medication) went unnoticed for several weeks. Staff need to be alert to the signs of damage.
9. Poor QC of Implantable Orthopedic Products
Implantable orthopedic products range from simple bone screws, rods, and plates to complex knee and hip prostheses. Defects in these products can delay or prolong surgery or can lead to infection, persistent pain or other long-term harm. ECRI has received or investigated reports of incorrect labeling (which can lead to the selection of the wrong product), device-device incompatibility, missing components and breaks or cracks in the device. Improved manufacturer QC practices are needed to ensure safe and efficient patient care.
10. Patient Confidentiality Considerations with Third-Party Web Analytics Software
Third-party web analytics software can provide businesses with valuable insights about how customers use their websites. For health care organizations, though, analytics tools installed on patient portals and other provider websites pose a hidden risk. They can allow third-party companies to collect information that could reveal details about the patient’s medical condition. This information may allow companies to track patients’ online activity and target the patient with ads promoting remedies – possibly unproven ones – for the medical conditions disclosed.
ECRI members can access the full report of the 2024 Top 10 Health Technology Hazards at this link.
https://ly.ecri.org/2024Top10Hazards.