When The Fence Eats the Crop: ECRI Top 10 Health Technology Hazards for 2013

How should medical device engineers react when the technology intended to better patient care actually becomes the thing that deters patient care?

Vimal K. Puthiyadath

There is a French saying, Le législateur devient le transgression, which translates into "The legislator becomes the transgression." It is not nearly as folksy as "The fence eats the crop," but the sentiment is the same. And it describes the feeling one gets upon glancing at the Emergency Care Research Institute (ECRI) list of top 10 health technology hazards for 2013 (registration required).

The ECRI says on its website:

As advances in health technologies provide new ways to improve patient care, they sometimes create new opportunities for harm… Our annual Top 10 list highlights the technology safety topics that we believe warrant particular attention for the coming year.

The institute's list is as follows:

  1. Alarm hazards
  2. Medication administration errors using infusion pumps
  3. Unnecessary exposures and radiation burns from diagnostic radiology procedures
  4. Patient/data mismatches in EHRs and other health IT systems
  5. Interoperability failures with medical devices and health IT systems
  6. Air embolism hazards
  7. Inattention to the needs of pediatric patients when using "adult" technologies
  8. Inadequate reprocessing of endoscopic devices and surgical instruments
  9. Caregiver distractions from smartphones and other mobile devices
  10. Surgical fires

The ECRI focuses only on what it calls "generic hazards" -- those risks that are inherent to the use of certain types or combinations of medical technologies. These hazards reflect use errors that are being repeated by clinicians or may become more prevalent as a technology is adopted more broadly.

These trends point to the need for increased awareness, for remediating steps, or even for improved design for a class of devices. Item No. 7 in the list was mentioned in an Adele Graham-King blog post last month. The recent focus on usability and mandatory risk analysis and determination of essential performance may alleviate some of the issues.

This is an alarming list, but the medical device designer must use it to make smart decisions about safety initiatives in the future. How can you use this list to improve your designs? Are there other health technology hazards that you think are more relevant to medical device design and packaging?

Focused on medical packaging design and technology?

Vimal K. Puthiyadath, Biomedical Electronics Engineer

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