ECRI top hazards: Alarms, data integrity, cybersecurity, device recalls

For the fourth year in a row, alarm fatigue tops the ECRI Institute's Top 10 list of health technology hazards. Meanwhile, cybersecurity has elbowed its way up the list of threats--and recall management makes a debut appearance.

"Based on our experience, there are serious safety problems that need to be addressed," James P. Keller, Jr., vice president, health technology evaluation and safety, ECRI Institute, says in an announcement.

The report includes an overview of each issue and recommended action steps for hospitals. The list is as follows: 

  1. Alarm hazards due to inadequate alarm configuration policies and practices
  2. Data integrity due to incorrect or missing data in electronic health records and other health IT systems
  3. Mix-up of IV lines leading to misadministration of drugs and solutions
  4. Inadequate reprocessing of endoscopes and surgical instruments
  5. Ventilator disconnections not caught because of mis-set or missed alarms
  6. Patient-handling device errors and device failures
  7. "Dose creep" due to unnoticed variations in diagnostic radiation exposures
  8. Robotic surgeries that lead to complications due to insufficient training
  9. Cybersecurity involving insufficient protections for medical devices and systems
  10. Over-stressed recall and safety alert management programs

While experts have worried about data integrity for several years and robotic surgery hazards appeared on the list last year, cybersecurity has elbowed its way up the list of worries and recall management appears for the first time.

ECRI experts are concerned that hospitals don't keep up with the number of medical device recalls from the U.S. Food and Drug Administration (FDA). The agency reported that recalls grew from 604 in 2003 to 1,190 in 2012, an increase of 97 percent. Even so, recent studies indicate the FDA' approval processes for medical devices are inadequate.

The Office of the National Coordinator for Health IT is in the process of setting up a health IT safety center to create a nationwide patient safety surveillance system to monitor HIT-related patient safety events.

The FDA Safety and Innovation Act report, released in April, included a recommendation to create the safety center. ONC's 2015 budget includes a $5 million allocation for the center.

To learn more:
- find the announcement