Published: Nov. 30, 2010
Updated: Nov. 30, 2010
A bronchoscope is an instrument that allows a physician to view the inside of a patient’s airways and lungs to detect abnormalities. How many bronchoscopes might an organization the size of Duke University Health System have in use? How about gastroscopes? Cystoscopes?
Jane Pleasants not only knows how many scopes there are at Duke, but where they are, who manufactured them, and much more. As assistant vice president for procurement at Duke Medicine, she was a key player in the response to a recent product recall of scope equipment by the Food and Drug Administration (FDA).
Pleasants and her team created an inventory of all the scopes in use at Duke, as well as the equipment used to disinfect them, immediately after the recall in December 2009. It was the disinfecting equipment that was being recalled -- but the situation was far less dire than it may sound.
“The FDA recalled the equipment, but said hospitals could keep using it until it was replaced,” says Gail Shulby, RN, chief of staff for clinical affairs and a member of the Senior Recall and Response Team. “There was no evidence that anyone had ever been harmed by it. It was an extremely unusual recall process.”
In a nutshell, says Shulby, the equipment was being recalled not because of any defects, but because the manufacturer had not gone through the FDA for approval after modifying its product.
“After very thoughtful consideration, in collaboration with our infection control professionals, we concluded that patients were not at risk,” says Shulby. “Nevertheless, we put in additional controls to ensure safety.”
Although replacing all the sterilization equipment is expensive, the lessons learned from the recall event are invaluable. “Each time we do this we learn,” says Shulby.
In addition to learning the details about every scope Duke Medicine has in use, the team learned that a database must be in place so that when a new scope comes in, it is centrally documented. This process is under way by Pleasants and her team.
Another revelation was the power of coordinated communication with the FDA. Duke was one of five institutions across the country that participated in a conference call with FDA officials, who, as a result, decided to extend the timeline for replacing the equipment.
Perhaps the most assuring lesson for all involved was that the Duke plan for recalls works. “Most organizations have to first figure out how to get all the key people together,” says Pleasants. “We have a Senior Recall and Response Team and a protocol in place. We can react very quickly.”