WASHINGTON – The Food and Drug Administration warned hospitals nationwide against reusing insulin pens on multiple patients in March 2009, 19 months before the Buffalo VA Medical Center began a practice that could have prompted its nurses to do that very thing.
What’s more, the hospital continued running the risk of spreading deadly viruses through those insulin pens for more than two years until last Nov. 1, despite a January 2012 alert from the Centers for Disease Control and Prevention reiterating the FDA’s earlier warning.
News of the government warnings – and the Buffalo VA’s apparent ignorance of them – only further infuriated members of Congress who are concerned that the faulty nursing practice could have exposed upwards of 716 patients at the local hospital to HIV, hepatitis B or hepatitis C.
“This is unacceptable,” said Rep. Chris Collins, R-Clarence. “We all would like to know how something like this could have been ignored.”
Evangeline Conley, a spokeswoman for the Buffalo VA Medical Center, on Thursday did not deliver a promised response to questions about the warnings and whether hospital officials had seen them – or ignored them.
In any case, the warnings could not have been much clearer.
“Insulin pens are not designed, and are not safe, for one pen to be used for more than one patient, even if needles are changed between patients, because any blood contamination of the pen reservoir could result in transmission of already existing blood-borne pathogens from the previous user,” the FDA said in its March 2009 alert to health care professionals.
The FDA issued its warning about the reuse of the insulin delivery devices following reports that William Beaumont Army Medical Center in Texas had potentially exposed at least 2,000 patients to deadly viruses through the reuse of insulin pens.
At least one other hospital also followed the same faulty practice, the FDA said at the time.
Some of the patients at the hospitals tested positive for hepatitis C, although it is unclear whether their exposure stemmed from the reused insulin pins.
The FDA also issued a news release at the time of the alert in which Dr. Amy Egan, deputy director of safety at the FDA’s Division of Metabolism and Endocrinology Products, said: “Insulin pens are designed to be safe for one patient to use one pen multiple times with a new, fresh needle for each injection.”
Despite such warnings, the reuse of the insulin pens recurred at other medical facilities, most notably the Dean Clinic in Wisconsin, which contacted 2,345 patients to warn them about possible exposure to deadly infections because one former employee was reusing the devices between 2006 and 2011.
In the wake of that revelation, the CDC issued its own, even more blunt warning in January 2012.
“The Centers for Disease Control and Prevention has become increasingly aware of reports of improper use of insulin pens, which places individuals at risk of infection with pathogens including hepatitis viruses and human immunodeficiency virus (HIV),” the warning said.
“This notice serves as a reminder that insulin pens must never be used on more than one person,” the warning added.
Ten months after that warning was issued, the Buffalo VA discovered that it had not been properly labeling insulin pens for single-patient use and immediately abandoned that faulty practice.
Local lawmakers are aghast, though, that the VA either never saw or completely ignored the government warnings.
“It is astounding and infuriating that the FDA and the CDC issued reminders not to reuse these insulin pens on multiple patients yet – somehow – the Buffalo VA still failed to follow proper protocols,” said Sen. Charles E. Schumer, D-N.Y.
Schumer and Rep. Brian Higgins, D-Buffalo, have called on the inspector general at the U.S. Department of Veterans Affairs to investigate what happened at the Buffalo VA hospital.
Meanwhile, Collins called for an outside audit and a “top-to-bottom review” of all the hospital’s procedures and practices.
“Clearly there were warnings about this, but this also falls under common sense,” he said.
“Unfortunately, there was a two-year lapse before anyone noticed this, and a lot of people were put at risk.”