Flawed recall; thousands at risk of deadly infection

Doctors track down contamination before realizing voluntary recall was issued

Mark A. DeSorbo

BALTIMORE, MD-Doctors at Johns Hopkins Hospital and U.S. Centers for Disease Control and Prevention officials are criticizing a bronchoscope manufacturer for a botched voluntary recall that put thousands of patients at risk of contracting a life-threatening lung infection.

They also complained that the U.S. Food and Drug Administration (FDA) left it up to the device's manufacturer, Olympus America Inc. (Melville, NY), to warn hospitals of the valve that harbors contamination within the bronchoscopes-snake-like, pencil-thin cameras that are used to examine lungs.

Detective doctors

Doctors, however, were already in hot pursuit of the contamination and located the source long before they even knew there was a recall on the bronchoscopes, says hospital spokesperson Gary Stephenson.

The problem, he explains, was discovered in December when doctors realized 128 patients had been infected with a bacterium known as pseudomonas at a rate of two to three times higher than the hospital would expect.

“When we became aware of this, our doctors took it upon themselves to talk to each other, and then we found out that there were more hospitals that didn't know about the recall,” Stephenson says. “The doctors pursued this. They sampled everything, the scopes, the cleaning equipment, the environment, and three of the seven bronchoscopes tested positive for this. It was good detective work on their part.”

Coincidentally, in early February, doctors became aware of a national recall letter, dated November 30, that was mistakenly addressed to the loading dock of the Hopkins physiology department.

“[Olympus] sent it to an area where the bronchoscopes are delivered, a loading dock,” Stephenson says. “Our understanding is that if there's a recall like this, it should have been more aggressive and sustained. Purchasers of the device and the clinicians who use it should have been notified here and at home. Sales reps should have been on hand as well to help pull these devices out of service, but there were no follow-up calls.”

At press time, possible infection from the Olympus bronchoscopes was suspected in two deaths, and Hopkins administrators were busy warning hospitals nationally and sending letters to 410 patients and their families indicating those at risk include anyone who had a bronchoscopy procedure between June 1, 2001 and February 4, 2002.

The letter asks patients to call their doctors if they experience symptoms that include fever, coughing, phlegm or shortness of breath. “Although it's not possible to know whether you are now at increased risk, it is important you be alert to any sign of infection,” the letter says.

“What recall?”

Meanwhile, Dr. Paul J. Scheel Jr., vice chairman of the Hopkins department of medicine, told The Sun of Baltimore that he and his colleagues had called several other hospitals to warn them of the risk of infection but that the universal reaction from other hospitals has been, “What recall?”

“I don't feel that a lot of institutions even knew about the recall. We were hopeful that the CDC and FDA would notify all of the institutions,” Scheel adds.

Calls placed by CleanRooms to the CDC, which hospital officials say is also investigating the matter, were not returned.

“We are aware of the situation and we are investigating,” says Kathleen Kolar, a spokes person for the FDA, who refused to answer additional questions from Clean Rooms.

Brad Stone, another FDA spokesperson, said in a statement, however, that the agency did not have to compel Olympus to perform a recall because the company volunteered to take that step in November.

The company seemed to take the proper steps by sending out the notices, he says.

“With any recall, we are trying to monitor it to make sure that the firm does as complete a job as can be expected and that the message gets out there effectively,” Stone says. “If any additional steps need to be taken, we will take them.”

The faulty valve in the bronchoscopes was discovered last September by a CDC investigator at a Nashville, TN hospital. Doctors at the unnamed hospital found that cultures from 17 patients who were examined with Olympus bronchoscopes tested positive for pseudomonas bacteria. A 50-year-old female cancer patient contracted pneumonia from the instrument but recovered.

The investigator, David Kirschke, concluded that a loose valve on the snake-like instruments allowed bacteria to form in a pocket where they could not be sanitized by sterilization equipment.

Hopkins administrators say Olympus sent a vaguely worded recall notice on November 30 to a loading dock at the medical school-the wrong address. The notice got lost in the in-house mail for a month and a half.

According to the FDA, the agency worked with Olympus to rework the language of the November 30 notice so that it was stronger and clearer in a second notice sent out February 27.

The first Olympus letter said the company is initiating the recall because of a “potential looseness” in a part that allowed “microbial contamination” of the instrument. The letter also said, “Olympus would like you to return the bronchoscope at your convenience” so that the company could “upgrade” the device.

The notice also indicated that the problems may be caused by improper cleaning, and Olympus advised hospitals to check the instrument's biopsy port for looseness, adding that if the piece is not loose “you may continue to utilize the bronchoscope.”

The biopsy ports are valves on the sides of the instrument through which technicians insert probes to take samples of lung tissue. Because the valves were loose, bacteria got under them and lodged in a way that prevented the normal sterilization equipment from killing them.

The second letter, issued February 27, is more specific and direct. It says “Urgent Re call” and directs hospitals that they are “required” to return the devices to the company.

As many as 4,400 faulty instruments were purchased by 2,361 hospitals across the country, Olympus officials indicate. The company maintains that it has been aggressive in notifying hospitals about the recall by certified mail. Nearly 40 percent of the flawed devices have been returned, an executive says.

“We take steps to communicate the best we can the urgency of the recall notices,” Sandra McDonald, executive director of professional services with Olympus, told The Sun. “They all state “urgent recall” and were sent to the attention of the pulmonology or infection control directors of the hospitals.”

Patients immuno-compromised

Most of those treated at Johns Hopkins, noted in 2001 by U.S. News and World Report as one of the nation's top hospitals, were suffering from cystic fibrosis, AIDS or lung cancer, or had recently had undergone lung transplants.

“Many of these patients were immuno-compromised,” Stephenson says. “Many of these people were extremely ill, so any kind of bacterial or viral infection is potentially life-threatening.”

The University of Maryland Medical Center in Baltimore has also stopped using the tool and is searching its records for patients with the infection, and the state Department of Health and Mental Hygiene and the Baltimore Health Department are trying to determine if the problem exists in other hospitals.

Physicians use the instruments to perform bronchoscopies, which inspect 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.

About 460,000 patients undergo the procedure every year in the United States.


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