What You Should Know:
– ECRI, the nation’s largest non-profit patient safety organization, names communications gaps with recalls of home-use medical devices as the nation’s most pressing health technology safety issue for 2023.
– ECRI’s Top 10 Health Technology Hazards for 2023 list identifies the potential sources of danger that will warrant the greatest attention for the coming year and offers practical recommendations for reducing risks.
Top 10 Health Technology Hazards for 2023
For 2023, ECRI’s report includes a series of challenges to industry, urging manufacturers to pursue device or process improvements that could mitigate—or even eliminate—some of the hazards included on the list. With healthcare facilities understaffed and healthcare workers overstressed, it’s more important than ever that technologies be designed in ways that ensure their safe use.
The 10 topics on ECRI’s 2023 hazards list are listed below in rank order:
1. Gaps in Recalls for At-Home Medical Devices cause patient confusion and harm
Accurate and understandable information about medical device recalls often does not reach patients using those devices in the home; this information gap is growing every year as healthcare moves into the home setting.
2. Growing Number of Defective Single-Use Medical Devices puts patients at risk
An unacceptably high number of defective single-use medical devices continue to be present in the supply chain. Single-use medical devices—which include products that are used once and then discarded, as well as those that get consumed during use—play a role in virtually every patient encounter. As a result, defective products can have a broad, negative impact on patient care, causing delays and increasing costs—and most concerningly, contributing to patient harm or death in some circumstances.
3. Inappropriate Use of Automated Dispensing Cabinet Overrides can result in medication errors
Automated dispensing cabinets (ADCs) are used to provide controlled access to medications near the point of care. These cabinets typically incorporate locked or lidded pockets, drawers, or other drug storage options. During routine use, practitioners enter their credentials at the ADC and select patient specific medications that have been reviewed and verified by a pharmacist.
Any deviation from safe ADC use practices could lead to the selection and removal of the wrong medication type, strength, or dose—errors that could lead to severe harm. For this reason, ADCs should be configured to require pharmacist approval prior to allowing access to a drug; the cabinet’s override feature should be used only for its intended purpose (when even a short delay would put the patient at risk); and use of the override feature should be routinely tracked and monitored.
4. Undetected Venous Needle Dislodgement or access-bloodline separation during hemodialysis can lead to death
Potentially life-threatening hazards can occur during hemodialysis, including the venous needle becoming dislodged at the vascular access point or the central venous catheter becoming separated from the bloodline used for treatment. Either event can very quickly lead to a massive loss of blood, and thus severe injury or death. Often, such events cannot be detected by a hemodialysis machine’s venous pressure monitor—and so will not produce an alarm.
5. Failure to Manage Cybersecurity Risks Associated with Cloud-Based Clinical Systems can result in care disruptions
Accessing a clinical service such as an electronic health record (EHR) or a radiology system through the cloud can offer significant benefits compared with more traditional systems. This deployment model does not, however, eliminate a healthcare delivery organization’s security considerations. It only changes them.
Organizations that do not both understand and plan for these differences will be at increased risk of a security event that could significantly disrupt patient care. Disruption of a cloud based service in a healthcare environment could lead to loss of availability or integrity of that service, with the potential to cause lengthy delays in care and adverse patient outcomes. Potential breaches of patients’ protected health information (PHI) are an additional concern.
6. Inflatable Pressure Infusers can deliver fatal air emboli from IV solution bags
Inflatable pressure infusers (IPIs) are simple, mechanical devices that compress an IV solution bag to allow pressure-assisted infusions. In certain circumstances, using an IPI to administer fluids creates an increased risk of infusing air from the IV bag into the patient—specifically, if (1) the air is not purged from the bag before use and (2) the bag is allowed to be compressed completely flat by the IPI during use.
ECRI recommends avoiding the use of IPIs for continuous infusion through vascular sheaths and catheters that terminate in the left heart. Even small amounts of air introduced in this location can be fatal.
7. Confusion Surrounding Ventilator Cleaning and Disinfection Requirements can lead to cross-contamination
Lack of clarity about the cleaning and disinfecting steps to be taken between patients can lead to ineffective reprocessing of ventilator components. This in turn increases the risk of cross contamination, an otherwise preventable occurrence that can lead to the spread of infectious disease.
8. Common Misconceptions About Electrosurgery can lead to serious burns
Electrosurgical units (ESUs) use concentrated electrical currents to cut and coagulate patient tissue at the site of application. These workhorses of the OR have been in use for decades. Nevertheless, misconceptions about their use persist, and the systems can—and sometimes do—cause unintended burns if operators do not fully understand the risks.
An incomplete understanding of the risks associated with any of the components involved in the electrosurgical circuit can lead to patient or clinician burns or other injuries.
9. Overuse of Cardiac Telemetry can lead to clinician cognitive overload and missed critical events
Overuse of cardiac telemetry monitoring—specifically, its use on noncardiac patients—can lead to alarm fatigue, clinician cognitive overload, and ultimately unrecognized critical events.
To minimize the risk, healthcare providers should establish clear criteria defining when telemetry monitoring should be used, as well as when it should be discontinued. In practice, this means verifying that telemetry is being prescribed appropriately (i.e., to monitor the right patient populations) and regularly assessing each patient’s need for continued telemetry monitoring.
10. Underreporting Device-Related Issues may risk recurrence
Reporting medical-device-related problems is crucial for keeping patients and staff safe. Unfortunately, problems aren’t always reported through appropriate channels, if at all. Healthcare organizations need to identify and eliminate barriers to reporting. Most importantly, they must make the reporting process as easy as possible in order to minimize disruptions to patient care tasks. Other measures include building a culture of safety (to encourage reporting), educating staff about how to identify device-related hazards, providing feedback to keep staff informed about the status of a report, and promoting the “wins”—that is, instances in which a report prevented significant harm or led to meaningful improvements.