Health Canada to review Vancouver evidence about medical device complications

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Material meant to help catheters slide through blood vessels can break off and travel throughout the body, potentially killing patients.

Health Canada is reviewing the findings of a Vancouver study that found fragments of coatings are breaking free from medical devices used in hospitals, sometimes causing patient deaths.

The B.C. study was the first to examine the problem in Canada. It was also the largest study of its kind based on autopsy findings. It showed that 23 per cent of those who died after their medical procedures had coating fragments in different parts of their bodies. But only three deaths were judged to be definitively caused by dislodged material travelling through the bloodstream to organs in the body. Physicians refer to this as a hydrophilic polymer embolism or HPE.

Dr. Tyler Hickey, a co-author of the study who is now at the University of Toronto and Ontario Forensic Pathology Service, said the co-authors were surprised at how many of the autopsy cases had evidence of the foreign material in vessels and organs such as the heart, lungs, kidneys and brain. “It may be that some complications after catheter procedures that we chalked up to bad luck are in fact due to unseen HPE that were released during the procedure,” said Hickey.

 

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