Bronchoscope Pseudomonas Outbreak Rattles Johns Hopkins

Officials Cite Poor Recall Notification

Two pulmonary patients at Johns Hopkins Medical Center have died of pneumonia after being treated with Olympus bronchoscopes that were recalled several months prior to the procedures. The bronchoscopes were voluntarily taken off the market by the company after it was determined in September that there was a design flaw in a biopsy port.

More than 415 pulmonary patients at Johns Hopkins Medical Center have been contacted after it was determined they may have been exposed to Pseudomonas aeruginosa because of the design error. Of those alerted, 100 have since tested positive.

The patients were reportedly treated with bronchoscopes that were recalled in November by the manufacturer, Melville, N.Y.-based Olympus.

Olympus officials report less than 40 percent of those hospitals contacted have sent back bronchoscopes for repair and inspection. Johns Hopkins officials say their recall notice was sent to the wrong address and it took two more months before it was routed to the appropriate department.¹

Officials from the Centers for Disease Control and Prevention (CDC) have since stepped in and are e-mailing hospitals and epidemiologists to alert them of the recall. The Food and Drug Administration (FDA) was reportedly notified of the recall in December, even though Olympus learned of the problem in September. FDA officials are reviewing the recall and their response.¹

Infection Control Team Finds Design Flaw

The driving force behind the recall is being credited to a team of healthcare workers at Skyline Hospital in Nashville, Tenn., that noticed a significant increase of pulmonary patients contracting pseudomonas infections in mid-2001. Pulmonary physicians observed pseudomonas infections in several patients and immediately contacted Jayesh Patel, MD, chairman of the hospital's infection control committee. The physicians originally thought the cultures had been done incorrectly, but they wanted to be sure. Patel asked Glenda (Gaye) Mayernick, RN, director of infection control at Skyline, to help him research a potential source of infection.

"We received new video bronchoscopes from Olympus on July 11 and on July 19 a bronchoscopy was performed on a same-day-care patient," Mayernick says. "Cultures of the bronchial washing grew Pseudomonas aeruginosa. On July 26, there were two other same-day-care patients that also grew Pseudomonas aeruginosa. We all know that pseudomonas is a common respiratory pathogen, but it is not so common in outpatients in the community and these patients were not sick with pneumonia."

After months of researching the source of infection to no avail, Mayernick and Patel contacted the Tennessee Department of Health (TDH) for help.

"We cultured even the things you wouldn't think would be a source of contamination, like the towels and cabinets," Mayernick says. "We continued to see positive cultures from bronchial washings. Patients were not sick, but the cultures were positive so we knew we had a problem."

Public Health Department Steps In

It took the research and know-how of a CDC epidemic intelligence service (EIS) officer to determine the source. David Kirschke, MD and epidemiologist currently working with the TDH, was poking and prodding the bronchoscope when he saw a potential design flaw. During an initial meeting with the endoscopy staff, Kirschke, Mayernick and Patel examined the structure of the instrument.

"Dr. Kirschke said, 'I think I remember reading something about a biopsy port being a source of contamination.' He starting fiddling with the cover around the biopsy port and the nurses told him it didn't come off," Mayernick says, describing the meeting. "Dr. Patel twisted it with his hand and it came off. So we cultured it."

After the hospital's three cultures of the port and the state's three cultures tested positive for Pseudomonas aeruginosa, the results were genetically compared to the strains in eight patients from the hospital that had recent bronchoscope procedures.

"They were identical, so we knew that was the source of the contamination. We thought it was an isolated incident, but we still took the scopes out of service," says Mayernick.

William Schaffner, MD, chairman of the department of preventive medicine at Vanderbilt Medical Center and consultant to the TDH, says the investigative work revealed the error in design.

"Because the bugs were in a protected location when the bronchoscope went through the reprocessing system, which was working just fine, the bugs were able to survive," he says.

Kirschke says it took several months to determine the exact source.

"We first went to the hospital Sept. 17 and they had a second outbreak at the end of October. We finished our investigation in mid-November when a company representative came to the hospital," says Kirschke. "They (Olympus) sent the recall letter out Nov. 30, which they told us they were going to do in mid-November."

Olympus officials say they were notified in September that a valve on their bronchoscope could come loose and harbor bacteria. However, a reported company investigation showed the bronchoscopes would not transfer bacteria if they were cleaned properly.²

Kirschke disagrees. After running the bronchoscope three times in a low-temperature sterile processing system, bacteria was still present. Additionally, Kirschke reportedly cleaned a recalled bronchoscope with ethylene oxide gas, only to find bacteria remained within the loose valve.²

"We found a loose part on the bronchoscopes from which we cultured pseudomonas in patient specimens. We linked them by DNA fingerprinting. The pseudomonas were the same from the scopes and the patient specimens," Kirschke says. "Apparently the company or the field representatives were unaware the manufacturer made this part removable. They told us we were not supposed to be able to take the part off, but it came off easily. We cultured pseudomonas from inside the biopsy part housing."

Schaffner said the hospital staff should be praised for calling Kirschke when they did. He also said they were fortunate to have a CDC EIS officer in Tennessee to aid in the investigation.

"They (Skyline officials) were not entirely sure what was going on," says Schaffner. "They were sure the patients did not have pseudomonas pneumonia, so that did not compute. So they figured they had an in-house problem. Incidentally, the patients did not become subsequently ill. They figured it was a contamination problem. Their own investigation did not come to a conclusion. So they did something for a hospital that is extremely commendable ... they called the department of health. This is a particularly refreshing for this hospital because they didn't have any sick patients."

Skyline officials report there is one patient who may have been infected by a bronchoscope at their facility, however the exact source of the patient's infection has not been determined. Twenty specimens revealed positive cultures.

Recall Begins

Lawrence Muscarella, PhD, endoscope infection control expert, says these situations are uncommon.

"Infections following bronchoscopy and gastrointestinal endoscopy are rare, but have been reported," he says. "Excluding design defects, breaches in the reprocessing protocol have been identified as the cause of each reported outbreak. Complicating factors can contribute to the failure of adequate endoscope reprocessing procedures. For example, the design of the instrument can affect the success of a cleaning and disinfection process. If an endoscope contains a channel or orifice that is very narrow and whose access is restricted, or if the endoscope contains a defective biopsy port whose design prevents thorough cleaning and disinfection, then the risk of nosocomial infection increases."

To compound the problem for Johns Hopkins officials, the majority of patients treated with their three recalled bronchoscopes were cystic fibrosis, AIDS or lung cancer patients with weakened immune systems. Hospital officials are working on an aggressive campaign to contact all patients. They also have opened a clinic to treat those who may have been exposed.³

More than 14,000 scopes have been recalled internationally. The cost to Olympus is estimated at $758,000.²

Sandie Harvey, BS, RRT, RN, an intervenional pulmonary nurse at the University of Nevada School of Medicine, says the recall surprised her. Harvey has worked as an registered respiratory therapist for more than 20 years and has never encountered this problem with Olympus scopes.

"We received a notice about the scopes in question and all scopes have been tended to. We had seven scopes on the list," she says. "We have not seen unexpected pseudomonas in our patients, but I cannot speak for patients in other practices." Pseudomonas is a tricky germ because it is found in soil and water. It can also live on the surfaces of plants, animals and humans and the bacteria are frequently resistant to antibiotics. Pseudomonas aeruginosa can cause infections of the urinary tract, blood, lungs and any previously compromised tissue.

Olympus Suggests Cleaning Error

According to Schaffner, the official recall from Olympus suggested the outbreak was not entirely caused by a design flaw.

The recall notice from Olympus includes the following clause: "An additional contributing factor in this instance was the failure by the user to maintain the automated endoscope reprocess (AER) to the manufacturer's recommended instructions."

"This distresses me," Schaffner says. "They say this is a contributing factor. I don't understand the basis. In fact, my analogy is like having an automobile manufacturer issue a recall on their car because it has been determined that at 60 mph the right front wheel comes off. And having the manufacturer say, 'Some of the drivers didn't change their oil regularly.' It is not germane. It drew attention away from where the real problem lay and contributed to the lack of the sense of urgency of the recall notice."

Mayernick agrees the company should not fault her facility's cleaning procedures.

"They would not have done a voluntary recall if it had been a problem with cleaning procedures," she says. "They came out here and said they agreed with our findings. They said we shouldn't be able to get that cap off with a sledgehammer. They thought that would be a good way to clean it and it was not."

Schaffner says the way the recall notice was written may have something to do with its reported lack of effect.

"The title says 'Urgent Recall' and the rest of the document is not at all urgent. It reads like an invitation to send back your bronchoscope. There is nothing insistent about it," he says.

Johns Hopkins officials did not return calls for an interview request. It is unknown if they will improve communication between manufacturers and hospital administration to prevent further problems.

Harvey said hospitals and manufacturers must learn to communicate to prevent future outbreaks.

"I think recalls should be handled with mailings to the parties that purchased the equipment, infection control departments, central sterile departments and gastroenterology and respiratory. Information can be sent out on association Web sites and other news bulletins," she says. "By targeting these areas, it would essentially notify the personnel that would be handling and cleaning the equipment."

Schaffner suggests the FDA should have more stringent requirements when it comes to notifying healthcare administration about such recalls.

"This is a skilled and technically excellent company that enjoys its reputation," he says. "Each of these bronchoscopes has a serial number. The company knew where each and every bronchoscope was and who was using them. They could have given that information to their sales force, given them a letter and said they all need to be back in the shop in three days. That is what I call a recall.

"The company knew that contamination carries with it an infection risk. That is well known. They are probably the world's experts in bronchoscope-related microbiology and its implications for patient care. Mind you, I am not suggesting for a moment that they did anything that was different than what the FDA would oblige them to do. I am just suggesting that the minimum was insufficient."

Muscarella says federal regulation of medical devices may be at fault.

"This recall of defective bronchoscopes by Olympus is of particular interest because it highlights several important issues that routinely arise in the field of endoscope reprocessing, infection control and the federal regulation and oversight of medical devices," he says. "Maybe most important, this recall reveals the extent to which poor instrument design can hinder contact of the cleaning and biocidal agents with every potentially contaminated surface, even if healthcare workers diligently adhere to the endoscope manufacturer's reprocessing instructions."

More than 460,000 bronchoscope procedures are performed annually in the United States.

It took the research and know-how of a CDC epidemic intelligence service (EIS) officer to determine the source. David Kirschke, MD and epidemiologist currently working with the TDH, was poking and prodding the bronchoscope when he saw a potential design flaw.

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