Device-related problems make the ECRI Institute's annual listing of top patient safety issues.

Marie Thibault

The Emergency Care Research Institute (ECRI Institute) has released its annual "Top 10 Patient Safety Concerns for Healthcare Organizations," naming some repeat offenders—like device reprocessing—to the list and welcoming new additions like IV line errors.

This is the second year the Patient Safety Concern list has been published, though ECRI Institute has put out a report on the "Top 10 Health Technology Hazards" for each of the past several years. The list was determined by studying safety events and including input from safety experts.

In the report, William M. Marella, MBA, executive director, operations and analytics for ECRI Institute’s Patient Safety, Risk, and
Quality group explains that "Our top 10 list isn't generated from a complicated algorithm or formula. It's very much a consensus process that attempts to distill the judgment of ECRI Institute's patient safety experts, our advisors, and our members. Topics are nominated based on our analysis of safety events reported to ECRI Institute and our partner Patient Safety Organizations as well as what's happeneing in the broader patient safety community."

Here are ECRI Institute's top 10 patient safety concerns (new items are bolded):

1) Alarm hazards: inadequate alarm configuration policies and practices
2) Data integrity: incorrect or missing data in EHRs and other health IT systems
3) Managing patient violence
4) Mix-up of IV lines leading to misadministration of drugs and solutions
5) Care coordination events related to medication reconciliation
6) Failure to conduct independent double checks independently
7) Opioid-related events
8) Inadequate reprocessing of endoscopes and surgical instruments
9) Inadequate patient handoffs related to patient transport
10) Medication errors related to pounds and kilograms

The device-related topics on the list—alarm hazards, data integrity failures, IV line mix-ups, and inadquate reprocessing—actually overlap with ECRI Institute's 2015 list of "Top 10 Health Technology Hazards."

Topping the list are alarm hazards, since alarm fatigue and unnecessary alarms have been a hot topic for years. Rob Schluth, senior project officer at ECRI Institute and lead project manager for the Top 10 Health Technology Hazards for 2015 project, said in the Patient Safety report that "in addition to missed alarms that can result from excessive alarm activations, hospitals also have to be concerned about alarms that don't activate when a patient is in distress. In our experience, alarm-related adverse events—whether they result from missed alarms or from unrecognized alamr conditions—often can be traced to alarm systems that were not configured appropriately."

Another key issue is ensuring that data entered into and shared between electronic health records is accurate. Data inaccuracy is not a new problem, Marella said in the report, but "now as EHRs become more interoperable, incorrect information is more readily available, more easily shared, and harder to eliminate." As the demand for EHR interoperability grows, making sure that the data captured by EHRs is accurate will grow increasingly important.

Mistakes with IV infusion lines is a top safety concern, and ECRI Institute recommends caregivers take several precautionary steps to prevent mix ups. This includes tracing back infusion lines to their origin pumps, labeling, using a consistent practice of placing certain infusion lines on certain sides of a bed, and recognizing that forcing connections usually means the hook ups are incompatible.

Finally, inadequate device reprocessing of endoscopes and surgical instruments, which made the safety concerns list again this year, remains at the forefront of safety discussions. The issue has found its way into mainstream media coverage because dozens of cases of carbapenem-resistant enterobacteriaceae (CRE) infections at hospitals around the country have been linked to duodenoscopes. Duodenoscopes are a type of endoscope used to diagnose and treat diseases of the live, bile dut, and pancreas. In recent months, FDA issued a safety communication pointing out that duodenoscopes can be difficult to sterilize completely because small space around its “elevator” mechanism can be hard to brush or clean perfectly. FDA has also released final guidance on medical device reprocessing. This gives manufacturers guidelines for cleaning, disinfecting, and sterilizing reusable devices that are reprocessed in the health care setting.

ECRI Institute has also published recommendations for duodenoscope reprocessing and culturing to prevent CRE infections.

Marie Thibault is the associate editor at MD+DI. Reach her at [email protected] and on Twitter @medtechmarie. 

[Image courtesy of HYWARDS/FREEDIGITALPHOTOS.NET]