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By Kelli M. Donley
Twopulmonary patients at Johns Hopkins Medical Center have died of pneumonia afterbeing treated with Olympus bronchoscopes that were recalled several months priorto the procedures. The bronchoscopes were voluntarily taken off the market bythe company after it was determined in September 2001 that there was a designflaw in a biopsy port.
More than 415 pulmonary patients at Johns Hopkins Medical Center have beencontacted after it was determined they may have been exposed to Pseudomonasaeruginosa because of the design error. Of those alerted, 100 have sincetested positive.
The patients were reportedly treated with bronchoscopes that were recalled inNovember by the manufacturer, Melville, N.Y.-based Olympus.
Olympus officials report less than 40 percent of those hospitals contactedhave sent back bronchoscopes for repair and inspection. Johns Hopkins officialssay their recall notice was sent to the wrong address and it took two monthsbefore it was routed to the appropriate department.1
Officials from the Centers for Disease Control and Prevention (CDC) havesince stepped in and are e-mailing hospitals and epidemiologists to alert themof the recall. The Food and Drug Administration (FDA) was reportedly notified ofthe 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 healthcareworkers at Skyline Hospital in Nashville, Tenn., that noticed a significantincrease of pulmonary patients contracting pseudomonas infections in mid-2001.Pulmonary physicians observed pseudomonas infections in several patients andimmediately contacted Jayesh Patel, MD, chairman of the hospital's infectioncontrol committee. The physicians originally thought the cultures had been doneincorrectly, but they wanted to be sure. Patel asked Glenda (Gaye) Mayernick,RN, director of infection control at Skyline, to help him research a potentialsource of infection.
"We received some new video bronchoscopes from Olympus on July 11, andon July 19 a bronchoscopy was performed on a same-day-care patient,"Mayernick says. "Cultures of the bronchial washing grew Pseudomonasaeruginosa. On July 26, there were two other same-day-care patients thatalso grew Pseudomonas aeruginosa. We all know that pseudomonas is acommon respiratory pathogen but it is not so common in outpatients in thecommunity, and these patients were not sick with pneumonia."
After months of researching the source of infection to no avail, Mayernickand Patel contacted the Tennessee Department of Health (TDH) for help.
"We cultured even the things in there you wouldn't think would be asource of contamination, like the towels and cabinets. We continued to see thepositive cultures from bronchial washings. Patients were not sick but thecultures were positive so we knew we had a problem," Mayernick says.
Public Health Department Intervenes
It took the research and know-how of a CDC epidemic intelligence service (EIS)officer to determine the source. David Kirschke, MD and epidemiologist currentlyworking with the TDH, was poking and prodding the bronchoscope when he saw apotential 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 biopsyport being a source of contamination.' He starting fiddling with the coveraround the biopsy port and the nurses told him that didn't come off,"Mayernick says, describing the meeting. "Dr. Patel took it and twisted itwith his hand and it came off. So we cultured it."
After the hospital's three cultures and the state's three cultures of theport tested positive for Pseudomonas aeruginosa, the results weregenetically compared to the strains in eight patients from the hospital that hadrecent bronchscope procedures.
"They were identical, so we knew that was the source of thecontamination. We thought it was an isolated incident but we still took thescopes out of service," says Mayernick.
William Schaffner, MD, chairman of the department of preventive medicine atVanderbilt Medical Center and consultant to the TDH said the investigative workrevealed the error in design.
"Because the bugs were in a protected location, when the bronchoscopewent through the reprocessing system, which was working just fine, the bugsnonetheless were not killed. They 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 outbreakat the end of October. We finished our investigation in mid-November when acompany representative came out to the hospital," says Kirschke. "They(Olympus) sent the recall letter out November 30, which they told us they weregoing to do mid-Nov."
Olympus officials say they were notified in September that a valve on theirbronchoscope could come loose and harbor bacteria. However, a reported companyinvestigation showed the bronchoscopes would not transfer bacteria if they werecleaned properly.2
Kirschke disagrees. After running the bronchoscope three times in alow-temperature sterile processing system, bacteria was still present.Additionally, Kirschke reportedly cleaned a recalled bronchoscope with ethyleneoxide gas, only to find bacteria remained within the loose valve.2
"We found a loose part on the bronchoscopes from which we culturedpseudomonas in patient specimens. We linked them by DNA fingerprinting. Thepseudomonas was the same from the scopes and the patient specimens,"Kirschke says. "Apparently the company, or the field representatives wereunaware the manufacturer had made this part removable. They told us that youwere not supposed to be able to take the part off, but it came off fairlyeasily. We cultured pseudomonas from inside the biopsy part cap/housing."
Schaffner said the hospital staff should be praised for calling foradditional help when they did. He also said they were fortunate to have a CDCEIS officer stationed in Tennessee to aid in the investigation.
"They (Skyline officials) were not entirely sure of what was going on.They were sure the patients did not have pseudomonas pneumonia, so that did notcompute. So they figured they had some sort of in house problem. Incidentally,the patients did not become subsequently ill," he says. "They figuredit was a contamination problem. Their own investigation did not come to aconclusion. 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 to have done because theydidn't have any sick patients."
Skyline officials report there is one patient who may have been infected by abronchoscope at their facility, however the exact source of the patient'sinfection has not been determined. Twenty specimens revealed positive cultures.
Lawrence Muscarella, PhD and endoscope infection control expert, says thesesituations are uncommon.
"Infections following bronchoscopy (and gastrointestinal endoscopy) arerare but have been reported. Excluding design defects, breaches in thereprocessing protocol have been identified as the cause of each reportedoutbreak. Complicating factors can contribute to the failure of adequateendoscope reprocessing procedures. For example, the design of the instrument canaffect the success of a cleaning and disinfection process," he says."If an endoscope contains a channel or orifice that is very narrow andwhose access is restricted, or if the endoscope contains a defective biopsy portwhose design prevents thorough cleaning and disinfection, then the risk ofnosocomial infection increases."
To compound the problem for Johns Hopkins officials, the majority of patientstreated with their three recalled bronchoscopes were cystic fibrosis, AIDS orlung cancer patients with weakened immune systems. Hospital officials areworking on an aggressive campaign to contact all patients. They have also openeda clinic to treat those who may have been exposed.3
More than 14,000 scopes have been recalled internationally. The cost toOlympus is estimated at $758,000.2
Sandie Harvey, BS, RRT, RN, an intervenional pulmonary nurse at theUniversity of Nevada School of Medicine said the recall surprised her. Harveyhas worked as an RRT for more than 20 years and has never encountered thisproblem with Olympus scopes.
"We received a notice about the scopes in question and all scopes havebeen tended to. We had seven scopes on the list," she says. "We havenot seen unexpected pseudomonas in our patients, but I cannot speak for patientsin outher practices that are colonized." Pseudomonas is a tricky germbecause it is found in soil and water. It can also live on the surfaces ofplants, animals and humans and the bacteria are frequently resistant toantibiotics. Pseudomonas aeruginosa can cause infections of the urinarytract, blood, lungs and any previously compromised tissue.
Olympus Suggests Cleaning Error
According to Schaffner, the official recall from Olympus suggested theoutbreak was not entirely caused by a design flaw.
The recall notice from Olympus includes the following clause: "Anadditional contributing factor in this instance was the failure by the user tomaintain the automated endoscope reprocess (AER) to the manufacturersrecommended instructions."
"This distresses me," Schaffner says. "They say this is acontributing factor. I don't understand the basis. In fact, my analogy is likehaving an automobile manufacturer issue a recall on their car because it hasbeen determined that at 60 mph the right front wheel comes off. And having themanufacturer say, 'Some of the drivers didn't change their oil regularly.' It isnot germane. It drew attention away from where the real problem lay andcontributed to the lack of the sense of urgency of the recall notice."
Mayernick agrees the company should not fault her facility's cleaningprocedures.
"They would not have done a voluntary recall if it had been a problemwith cleaning procedures," she says. "They came out here and said theyagreed with our findings. They said you shouldn't be able to get that cap offwith a sledgehammer. They thought that would be a good way to clean it and itwas not."
Additionally, Schaffner says the way the recall notice was written may havesomething to do with its reported lack of effect.
"The title says 'Urgent Recall' and the rest of the document is not atall urgent, but instead, it reads like an invitation to send back yourbronchoscope. There is nothing insistent about it," he says.
Johns Hopkins officials did not return calls for an interview request.
Harvey said hospitals and manufacturers must learn to communicate to preventfuture outbreaks.
"I think recalls should be handled with mailings to the parties thatpurchased the equipment, infection control departments, central steriledepartments and gastroenterology and respiratory. Information can be sent out onassociation Web sites and other news bulletins," she says. "Bytargeting these areas, it would essentially notify the personnel that would behandling/cleaning the equipment."
Schaffner suggests the FDA should have more stringent requirements when itcomes to notifying healthcare administration about such recalls.
"This is a skilled and technically excellent company that enjoys itsreputation. Each of these bronchoscopes has a serial number. So, the companyknew for all intents and purposes where each and every bronchoscope was and whowas using them," he says. "They could have given that information totheir sales force, given them a letter and said they all need to be back in theshop in three days. That could have been done and time zero. That is what I calla recall.
"The company knew that contamination carries with it an infection risk.That is well known. They are the world's experts probably in bronchoscoperelated microbiology and its implications for patient care. Mind you, I am notsuggesting for a moment that they did anything that was different than what theFDA would oblige them to do. I am just suggesting that the minimum wasinsufficient."
Muscarella says federal regulation of medical devices may be at fault.
"This recall of defective bronchoscopes by Olympus is of particularinterest because it highlights several important issues that routinely arise inthe field of endoscope reprocessing, infection control, and the federalregulation and oversight of medical devices," he says. "Maybe mostimportant, this recall reveals the extent to which poor instrument design canhinder contact of the cleaning and biocidal agents with every potentiallycontaminated surface, even if healthcare workers diligently adhere to theendoscope manufacturer's reprocessing instructions."
There are more than 460,000 bronchoscope procedures performed in the UnitedStates annually.