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Compliance News: ECRI Institute Lists Top 10 Health Technology Hazards for 2015

| David Stymiest

Hospitals are expected to identify risks that can adversely affect the safety of patients and others.  As an example, under TJC’s Standard EC.02.01.01, Element of Performance 1 lists examples of both internal and external sources of information on probable risks.  The annually updated ECRI list of Top 10 Health Technology Hazards is not listed but is also a source that should be taken into consideration.

The ECRI Institute recently published a free 33-page special report entitled “ECRI Institute 2015 Top 10 Health Technology Hazards.”  This comprehensive report includes a multitude of useful recommendations along with exhaustive lists of further reference publications.  Readers are strongly encouraged to use this link to acquire their own copies of the new ECRI publication for review and appropriate action.

In its introduction, ECRI encourages facilities to incorporate its top 10 list of generic hazards “into plans of action at your hospital and to find individuals who can learn about each hazard in depth and educate and influence their peers about the appropriate risk-mitigation strategies.”

ECRI considered a number of factors in determining which hazards actually made it to the top 10 list, including the degree of severity, frequency or likelihood of the hazard, how widespread is the hazard, whether the problem is difficult to recognize, whether the hazard has a high media or regulatory profile, and whether preventive actions can be effective.

The hazards discussed by ECRI are listed below as ECRI lists them.  Several hazards on the 2015 list have been listed by ECRI in previous years.  Most of these hazards are also receiving substantial attention from accrediting organizations and other authorities having jurisdiction.  On first glance the list appears to be about medical equipment; however a closer review of the ECRZI document indicates that many of these hazards can fall under multiple Environment of Care (EOC) or Physical Environment (PE) areas, and require oversight by hospital EOC and Safety Committees as well as Patient Safety Committees.

  1. Alarm Hazards: Inadequate Alarm Configuration Policies and Practices
  2. Data Integrity: Incorrect or Missing Data in EHRs 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 Use Errors and Device Failures
  7. ‘Dose Creep’: Unnoticed Variations in Diagnostic Radiation Exposures
  8. Robotic Surgery: Complications due to Insufficient Training
  9. Cybersecurity: Insufficient Protections for Medical Devices and Systems
  10. Overwhelmed Recall and Safety-Alert Management Programs

Building on previous initiatives that focused on alarm fatigue, ECRI stated that inappropriate alarm configuration practices also need to be a focus.  As it does with all 10 hazard types, the ECRI document provides examples of the areas of concern along with detailed recommendations for addressing them.

Addressing an area that has seen considerable ongoing scrutiny by CMS and the accrediting organizations, ECRI’s includes reprocessing of endoscopes and surgical instruments.  ECRI stated that 7 of the 13 immediate threat to life (ITL) findings from 2013 TJC surveys were directly related to improper sterilization or high-level disinfection of equipment.  Facility managers are well aware of the physical environment aspects of this issue.

ECRI cited several examples of patient-handling device use errors, including improper use of patient lifts of various designs, issues associated with mobile patient lifts, and use issues associated with transfer boards.  It also cited examples of problematic device failures.  The ECRI recommendations include details on training, education, quantities and availability/accessibility of equipment where and when needed, equipment selection, and management of accessories.  ECRI also discusses the need for timely and appropriate equipment inspection, maintenance and repair.

In its detailed discussion of cybersecurity issues with medical devices and systems, ECRI also mentions inconsistent support for this issue from the IT industry.  For TJC-accredited organizations, this concern may also come under the realm of the utility portion of the physical environment (environment of care) since TJC lists “communication systems, including data exchange systems” as utility systems in its accreditation manual glossary.