The ECRI Institute has published a list of the top 10 health technology hazards for 2024.
Topping the list is the notion that “medical devices may pose usability challenges for home users, risking misuse and patient harm.” The write-up emphasizes that medical devices are often not designed with home users in mind and the fact that home settings can introduce certain environmental limitations that can impact the operation of the device. These usability challenges can lead to outcomes as drastic as “tragic fatalities that occurred when a ventilator alarm failed to activate.” Also emphasized is the need to offer support to home users in how to operate the device successfully and safely.
Second on the list is the issue of “inadequate or onerous device cleaning instructions” that can “endanger patients.” Of course, failing to properly clean medical devices can lead to things like “the spread of infection [and] device damage,” and the lack of standardization across devices when it comes to reprocessing instructions just adds to the confusion and risk. Issues like “incomplete, impractical, or onerous reprocessing instructions” can lead to healthcare workers themselves having great difficulty to complete the tasks effectively, which leads to both a risk for the patients and the healthcare workers themselves. ECRI suggests asking if the vendor will “provide validated reprocessing instructions for the product” and if the reprocessing steps are “practical to complete in your environment.”
Another issue outlined by the list is “sterile drug compounding without the use of technological safeguards,” which can increase the risk of medication errors. Drug compounding is “required when a commercially available formulation does not come in a ready-to-administer form or does not otherwise meet patients’ needs,” involving “combining, reconstituting, repackaging, or otherwise modifying a drug product to create a new preparation.” Specifically, injectable drugs can have “severe--sometimes deadly—consequences” if there are issues in compounding that go undetected. ECRI recommends measures like “workflow management systems” in order to “minimize opportunities for human error in the sterile compounding process.”
The next hazard emphasized by ECRI is the “overlooked environmental impacts of patient care” that endanger “public health.” The environmental cost of the medical devices, supplies, and systems used to ensure the best in patient care often “exacerbate health inequities, since many of the health risks associated with environmental stressors disproportionately impact disadvantaged communities.” ECRI proposes strategies such as “reducing the amount of energy consumed by medical imaging equipment, choosing alternatives to anesthetic gases that have high global warming potential, and eliminating purchases of unnecessary single-use items…that contribute directly to waste volumes.”
Another hazard comes in the form of single-foil conductive return electrodes. The issue here is that these “do not engage a key electrosurgical unit (ESU) safety feature—the return electrode contact-quality monitor (RECQM).” RECQMs “detect when contact between a return electrode and the patient is compromised,” which can lead to electrosurgery-related burns. There were four reports of burns received by ECRI in 2023 associated with the use of single-foil conductive return electrodes, and in some of these cases, clinicians were “not aware of the associated risks, nor that safer alternatives were available.”
ECRI also emphasizes that “infusion pump damage remains a medication safety concern.” Specifically outlined is one recent incident in which “a patient was harmed when a pump allowed an infusion to flow freely (under the force of gravity) to the patient” as a result of a key component of the pump having broken off several weeks earlier. ECRI stresses that “staff need to be alert to the signs of damage” when handling infusion pumps, which are “routinely subjected to circumstances that can lead to damage.”
Another issue reported by ECRI is the “prevalence of quality control (QC) issues” in “implantable products intended for use during orthopedic procedures.” Specifically, ECRI received reports of “incorrect labeling or packaging…device-device incompatibility…[and] defects,” all of which can lead to subsequent pain or injury, delays in patient treatment, and implant failure. To fix this issue, ECRI recommends that users “look for and report signs of defects before use” as well as “tracking defects that are reported,” holding manufacturers and distributors accountable for any errors.
ECRI has the full list here.