WASHINGTON- A number of Maryland hospitals still had at least one defective bronchoscope as of this week, when Johns Hopkins Hospital tentatively linked two patient deaths and many illnesses to recalled medical devices.
State health officials said none of the other hospitals have reported patient illness or death so far as a result of an Olympus America Inc. bronchoscope, a long tube that is inserted into the lungs for examination and tissue sampling.
Olympus had recalled the devices late last year — a fact that officials at Hopkins learned only after their own investigation into the pneumonia deaths of two patients and the infection of about 100 others led to the bronchoscope.
“Our doctors, as soon as they became aware of this, they started calling their colleagues all across the country,” to warn about problems with the bronchoscope, said Hopkins spokesman Gary Stephenson.
The state Department of Health and Mental Hygiene and the Maryland Hospital Association are also working to get the word out to Maryland hospitals.
A full tally of the state’s hospitals is not yet available, but one official estimates that the majority of hospitals in Maryland still had the defective bronchoscope when the Hopkins story broke.
Dr. Ross Brechner, the state epidemiologist, said about a quarter of Maryland’s 52 hospitals responded to his e-mail asking if they were using recalled bronchoscopes. Based on that response, he predicts that 80 to 85 percent of Maryland hospitals were using at least one defective bronchoscope and had not been aware of the recall until this week.
The scopes had loose valves that could trap and transmit bacteria from patient to patient. Hopkins officials suspect the device spread pseudomonas aeruginosa, a bacteria that causes infection in sick or weakened immune systems and is often resistant to antibiotics. But they cannot blame the infections for sure in the outbreak they noticed earlier this year.
“It’s difficult to establish a direct cause-and-effect relationship in patients that were desperately ill to begin with,” Stephenson said. “This is a population that one would expect to find elevated rates of infection in.”
He said pseudomonas infection “can be very dangerous for anybody, but particularly in people with impaired or compromised immune systems, such as HIV/AIDS or transplant patients.”
Olympus recalled the instruments late last year after a Tennessee hospital traced a patient infection to its bronchoscopes. The Tennessee hospital notified the Food and Drug Administration as well as Olympus, which issued a voluntary recall of 4,700 bronchoscopes, sending letters to 2,361 hospitals.
But Hopkins said its letter was sent to its loading dock, and was not found until the recent investigations. Some other hospitals around the state said they did get the notice and they returned their defective bronchoscopes, but some, like Hopkins, were in the dark until this week.
“The smaller the hospital, the more likely they were to get the recall letter,” Brechner said.
Calvert Memorial Hospital got a recall letter in December for one of its two bronchoscopes. It sent the recalled device to Olympus for repairs and got it back in February.
The hospital’s infection control practitioner Judith Sturgis said the hospital had only used the defective bronchoscope once before it received the recall notice and has not needed to use it since it was repaired.
But Robin Klinefelter, spokeswoman for Kent and Queen Anne Hospital in Chestertown, said she does not believe it received a recall notification in December. She said the hospital heard about the recall on the news over the weekend and got a certified letter about the recall Monday from Olympus.
Klinefelter said the 49-bed hospital uses its two bronchoscopes for five or six procedures a month.
“We’ve checked our equipment and there doesn’t seem to be a problem with ours,” she said. “But we are going to send them to Olympus to be replaced.”
North Arundel Hospital did not receive a recall letter last December, either.
“We got notified from the company yesterday,” spokesman Kevin Murnane said Tuesday. “But we pulled it over the weekend when we heard about it from the media.”
Maryland Hospital Association spokeswoman Nancy Fiedler said she sent notice of the recall to hospitals Monday and has had no reports of infections from any hospitals other than Hopkins. But she said it is too early to determine the impact on the state’s hospitals.
“The recall obviously was not done as visibly as these recalls normally are,” she said.
Olympus reports that about 40 percent of the recalled bronchoscopes were replaced prior to the Hopkins incident.
FDA spokeswoman Kathleen Kolar said the agency is investigating both Olympus’s handling of the recall and the Hopkins incidents.
“Most recalls are voluntary by the company,” she said. “Our role is, essentially, to monitor the adequacy of the recall.”