Doctors at Johns Hopkins Hospital suspect that a defective medical instrument was responsible for spreading a potentially life-threatening lung infection to patients, officials said yesterday. More than 400 patients - or their families - are being notified that they may have been affected.
Hopkins officials said they had not determined how many patients had been sickened or died as a result of their examinations with a device called a bronchoscope, which has been recalled by the manufacturer. Hospital officials discovered the problem after realizing that an unusually high number of patients had been infected with a bacterium known as pseudomonas.
Most of the 415 patients involved suffered from cystic fibrosis, AIDS or lung cancer or had recently had lung transplants. Dr. Paul J. Scheel Jr., vice chairman of medicine, said the number of those patients infected with pseudomonas - 128 - was two to three times higher than the hospital would have expected.
Some of the patients have died, he said, but the hospital was unsure how many died of their underlying disease, of pre-existing pseudomonas or from bacteria introduced by the equipment. He would not say how many had died.
"We don't know the cause and effect between patients who died and this infection," Scheel said. "People are going through medical charts to try to ascertain this."
Two federal agencies, the Centers for Disease Control and Prevention and the Food and Drug Administration, are investigating the problem, in part to determine if the device has triggered outbreaks elsewhere. Scheel said at least one other hospital had reported problems with the instrument. He said he did not know the name of that hospital.
The Maryland Department of Health and Mental Hygiene and Baltimore City Health Department are working to see if the problem exists in other local hospitals.
Hopkins has seven bronchoscopes of the model that was recalled last November by Olympus America, the manufacturer. That recall was apparently prompted by the discovery of suspicious infections at the unnamed hospital.
But the recall letter, dated Nov. 30, was mistakenly addressed to the loading dock of the Hopkins physiology department.
In December, Hopkins doctors realized that there was a high infection rate among hospitalized patients who had undergone bronchoscopies. The hospital launched an intense investigation, examining sinks, drains, fluids and various instruments before tracing the problem to a loose part on the bronchoscope that apparently trapped bacteria and made the standard disinfecting technique ineffective. On Friday, hospital officials began calling hundreds of patients who had been examined with the defective equipment.
Certified letters informing patients of the problem and asking them to contact their doctors if they experience symptoms are due to go out tomorrow. The symptoms include fever, coughing and shortness of breath.
Hospital officials provided information to The Sun yesterday, although they had hoped to delay discussing the problem publicly until patients had been notified.
Hopkins physicians have begun notifying pulmonary doctors at large institutions around the country that they, too, might be affected. "We have been banging the drums to have anyone who will listen to us make sure this is not happening in their place," Scheel said.
Dr. Trish Perl, director of infection control at Hopkins, said she is "very concerned that this is a much larger problem than Hopkins." It is not clear how many of the devices were being used in U.S. hospitals. Olympus officials were not available last night for comment.
Physicians perform a bronchoscopy to look into a patient's lungs and take tissue samples. A thin, tube-like instrument, about the width of a pencil, is placed through the nose or mouth and into the lungs. The tube has a tiny camera at the tip and uses fiber-optic technology to produce pictures of airways.
The procedure can help physicians determine the cause of bleeding in the lung or check for foreign bodies, tumors and infections, including tuberculosis and AIDS-related pneumonias.
If a doctor sees a suspicious area during bronchoscopy, small tissue samples are removed for laboratory examination. About 460,000 patients undergo the procedure in the United States every year.
The complication rate for bronchoscopies is considered extremely low, though patients are warned to watch for bleeding, breathing problems or fever.
At Hopkins, doctors began suspecting a problem in late December when they noticed that a large number of patients examined with bronchoscopes were testing positive for pseudomonas bacteria.
Although pseudomonas infections are fairly common among patients with impaired immune systems, the frequency of infections among patients who had recently undergone bronchoscopies prompted doctors to see if some were acquiring the bug from a hospital source.