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Nurses not reporting faulty devices to Ottawa

94.2% unaware of Health Canada data collection: study

Joseph Brean

Originally appeared in the National Post

Nurses in Ontario are almost totally unaware of a Health Canada program to collect data on malfunctioning medical devices, according to a new study.

It shows faulty medical equipment might be "severely under-reported" in Canadian hospitals, not because the voluntary reporting system is too complicated or bureaucratic, but because nurses do not even know it exists, said Kim Vicente, an expert in medical industrial design, in an interview.

Health Canada, however, maintains its monitoring system is "solid."

Prof. Vicente's report, based on the survey responses of 260 registered nurses in Ontario, gauged their awareness and use of Health Canada's "post-market surveillance program" for the 455,000 different medical devices approved for use in hospitals -- from such critical machines as drug-infusion pumps to more mundane gadgets such as asthma inhalers.

Unlike manufacturers and distributors, who are required to report any known problems with their devices, doctors and nurses are merely encouraged to fill out a form and send it to the regulator, which can then evaluate it, act upon it and share it nationally. In a similar U.S. program, nurses are among the most frequent discoverers and reporters of faulty equipment.

The survey found 73% of the Ontario nurses encounter malfunctioning equipment at least once a year, and 25% had problems at least once a month, but fully 94.2% did not know Health Canada wants to hear about it. The study appears in the current Canadian Journal of Nursing Leadership.

"It seems like such a little thing to look at. You assume, of course they're familiar with [the reporting program]," said Prof. Vicente, a University of Toronto professor of mechanical and industrial engineering.

"Well, it turns out it is a big deal because 94% of nurses had never heard of the form before, which is astounding," he said. "Of the ones that were familiar with it, I think only three had ever used it."

"There's no feedback going from the nurses to the regulators," he said.

Etienne Ouimette, director of compliance and enforcement in Health Canada's Health Products and Food Branch Inspectorate, agreed that medical malfunctions are probably under-reported. But he said the agency promotes the surveillance program each time it issues warnings about malfunctioning devices, which it does frequently.

In 2003-04, for example, manufacturers and distributors filed 859 mandatory reports, compared to 203 voluntary reports from nurses, doctors or patients. There were 670 devices recalled from the market that year.

Prof. Vicente said his research suggests these numbers are "much, much less than the actual number of problems."

A landmark 2004 study found that between 9,250 and 23,750 patients die in Canada each year because of preventable medical errors. A separate study showed that for every 1,000 hospital admissions, there will be 83.7 medical device malfunctions.

Mr. Ouimette agreed the reporting program is flawed, but said it is valuable and ought to be improved rather than scrapped.

"The objective of that program is to make sure that we receive enough information so that we can trend problems and we can follow up with the manufacturers accordingly, and also inform other hospitals that may be using the same devices....

"I think that the benefit is real," he said.