1. Gaps in Recalls for At-Home Medical Devices Cause Patient Confusion and Harm
When a medical device that is used in the home is recalled, too often users don’t learn about the recall in a timely manner; and whatever information they do receive may be too technical for them to comprehend. Without a clear understanding of the risks, patients may be harmed by continuing to use an unsafe device – or by inappropriately stopping use of a device whose benefits outweigh the risks.
With health care increasingly moving to the home setting, the lack of a recall process that meets the needs of home users is a growing concern. In ECRI’s view, medical device manufacturers need to be more proactive in creating clear, easy-to-understand recall notices and getting those notices into the hands of the people using their devices.
2. Growing Number of Defective Single-Use Medical Devices Puts Patients at Risk
Disposable products and other types of single-use medical devices play a role in virtually every patient encounter, which is why the unacceptably high number of defective products in the supply chain is of such concern. ECRI has received reports of cracked tubing and connectors; compromised sterility of needles, catheters, and procedure kits; and incorrect product labeling. These are just a few examples of product defects that can lead to waste, delays, incorrect treatment, healthcare-acquired infections or other patient harm. Concerningly, rather than seeing improvements over time, ECRI has observed a continuing increase in problem reports.
There are steps that health care providers can take to protect patients, staff and others from the use of defective products. However, the greatest impact will come from manufacturers improving their quality control practices to prevent defective products from reaching the market.
3. Inappropriate Use of Automated Dispensing Cabinet Overrides Can Result in Medication Errors
Automated dispensing cabinets (ADCs) provide controlled access to medications near the bedside. In an emergency, an ADC’s controls can be overridden so that medications can be accessed more rapidly. This is a risky practice in that it bypasses the pharmacist’s review of the medication order, thereby increasing the risk of a medication error. For that reason, overrides should be considered only when dictated by clinical circumstances. Too often, however, practitioners view the override process as a routine step, rather than a risky one. Any deviation from safe use practices could lead to the selection and removal of the wrong medication type, strength or dose – errors that could be fatal.
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 very quickly leads 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 the differences will be at increased risk of a security event that could significantly disrupt patient care.
6. Inflatable Pressure Infusers Can Deliver Fatal Air Emboli from IV Solution Bags
Inflatable pressure infusers (IPIs) are simple 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. This could cause an embolism that, depending on its size and location, could lead to circulatory collapse, stroke or death. Using IPIs to infuse through intracardiac catheters and sheaths is of particular concern.
7. Confusion Surrounding Ventilator Cleaning and Disinfection Requirements Can Lead to Cross-Contamination
Reprocessing instructions provided by ventilator manufacturers are, in some cases, incomplete or confusing; and even guidance from regulatory authorities can be unclear. Questions can exist about which components need cleaning/disinfection and when. Lack of clarity about the steps required between patients increases the risk of cross-contamination and the spread of infectious disease.
8. Common Misconceptions about Electrosurgery Can Lead to Serious Burns
Misconceptions surrounding the use of monopolar electrosurgical units can – and sometimes do – lead to unintended burns. Common misconceptions include: (1) That using multiple ESUs simultaneously on one patient presents no added risk. In reality, burn risks can increase exponentially in this scenario. (2) That the active electrode should be activated before its tip is in contact with the patient. In fact, doing so causes a high voltage to develop in the circuit, increasing the likelihood of injury. (3) That the return electrode pad can never be safely applied over an orthopedic metal implant, tattoo or piercing. ECRI’s laboratory testing calls that assumption into question as well.
9. Overuse of Cardiac Telemetry Can Lead to Clinician Cognitive Overload and Missed Critical Events
Using cardiac telemetry on patients who do not require that level of monitoring invariably leads to an increase in alarms that vie for the clinician’s attention. The increased alarm load can overwhelm and distract care providers, possibly leading to a critical alarm being missed and a patient’s deterioration going unrecognized.
10. Underreporting Device-Related Issues May Risk Recurrence
Reporting medical-device-related problems when they are observed is a crucial safety practice, so that problems can be remedied before patient care is affected. Unfortunately – as clinical engineers and biomeds know all too well – faulty devices are not always reported through appropriate channels. Staff may find the reporting process to be too onerous, they may be unable to interrupt a patient care task to submit a report, they may not know how to report, or they may see little benefit to reporting. Such barriers need to be addressed in order to prevent harm.
To Learn More . . .
This article is adapted from ECRI’s Top 10 Health Technology Hazards for 2023. An Executive Brief version of that report is available for complimentary download at www.ecri.org/2023hazards. The full report, accessible to ECRI members, provides detailed steps that organizations can take to prevent adverse incidents.
To learn more, contact ECRI at (610) 825-6000, ext. 5891, or by email at clientservices@ecri.org.
