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Patient safety & the medical device industry – A chance for reform?

Posted Jun 10 2010 5:29am

By Ed Howe
Former President and CEO, Aurora Health Care

Grena Porto is a nationally recognized expert when it comes to patient safety. She is well known in healthcare circles.

Recently, Grena Porto sent out a note regarding medical device companies and patient safety. In the past I have been critical of the device industry for selling their products through relationships, rather than the value and price of their products. She raises an issue that certain companies are marketing on patient safety without really contributing to the safety issue.

This would be a wonderful opportunity for manufacturers, GPOs and regulators to come together to develop stringent design standards that avoid human errors. How about giving it a try? Thanks to Grena for her thought-provoking note. With her permission you can read it below:

Grena Porto’s note

Hi, everyone. I wanted to give you a heads up on a dangerous trend that I see emerging in patient safety circles. Many manufacturers have, at long last, caught on to the fact that they might have a role in helping users avoid errors while using their products. Unfortunately, most have been slow to adopt any design changes that might actually enhance safety and are instead embracing relatively simple fixes that have little to recommend them, such as color coding. 

Two examples of this are color coded IV tubing and IV pumps with screens that can be programmed to different colors for different infusions. Another example is color coded patient ID bands, which have been around for a while and have even gotten tacit acceptance from regulators via standardization recommendations. Color coding is not a particularly effective design for avoiding error and in fact has actually caused some disastrous errors, largely because of cognitive failure of the individual to see or interpret the color accurately coupled with the false sense of security that you’ve got it right. 

Lack of standardization and the existence of multiple schemes for different uses and settings is also a problem. Color coding of medical gas cylinders has led to disastrous incidents in which patients have been connected to CO2 instead of oxygen, and there are reports of patients who were not resuscitated because someone saw and misinterpreted a “Livestrong” bracelet. 

So, if you get any well-meaning requests to buy some of these color coded items, or to adopt color coding as a safety strategy, you might want to take a close look at the product design and also the human factors literature on color coding. I am attempting to get the Joint Commission to issue a Sentinel Event Alert on the hazards of color coding, so there may be some guidance on this in the near future. (Note: There was already a Sentinel Event Alert on medical gas cylinders back in 2001, and the FDA has also issued an alert on them.)

 

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