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By Kathy Dix
Outbreaks are a frightening occurrence in any healthcaresetting, but offer an opportunity to improve processes and procedures in orderto prevent future outbreaks. Infection Control Today explored the causes and effects behinda 2001 outbreak that spread pseudomonasto several patients at two differentinstitutions.
In September 2001, Glenda Gaye Mayernick, RN, CIC, director ofinfection control at Skyline Medical Center in Nashville, notified the TennesseeDepartment of Health of an increase in the number of Pseudomonasaeruginosa and Serratiamarcescens isolates associated with bronchoscopy, asreported in the New England Journal of Medicine inJanuary 2003.
Mayernick and her colleagues had been following a possibleoutbreak at their facility since July 2001, when a bronchoscopy performed on asame-day care patient yielded a bronchial washings culture that grew P.aeruginosa. Two other patients undergoingbronchoscopies also had cultures that grew P.aeruginosa. Two pulmonologists who had performed theprocedures spoke with the chairman of the infection control committee, feelingthat the cultures were contaminated, as the patients did not appear to haveclinical Pseudomonas pneumoniaand none had a prior history of Pseudomonas.
The director of infection control and the director of surgicalservices both reviewed cleaning procedures and found no problems. However, patients continued to have positive Pseudomonas cultures after bronchoscopy. The staff took culturesof the most likely sources of contamination, but all potential sources appearedto be clean water from the washer, water from the scope cleaning sink, andfrom a bottle of saline used with the procedures.
Pseudomonas isolates were preservedfor possible pulsed field gel electrophoresis comparison as more cultures testedpositive for P. aeruginosa;additional cultures were obtained from the outlet from compressed air, traps inthe washer/disinfector, lubricant used in the procedure, the alcohol, theenzymatic cleaner, the cleaners cup, the lidocaine used in the patientsnoses, and the high-level disinfectant. Still no source was revealed.
The state public health department was notified and wasrequested to help; an officer from the Epidemic Intelligence Service (EIS) ofthe Centers for Disease Control and Prevention (CDC) was dispatched while stillmore cultures were obtained, from epinephrine used for the scopes injectionport, from sterile D5W, a needle used for injecting saline during the procedure, the suction button on the scope,the tips of the scopes, the scissors used to cut the tip off the D5W, the towelused in the bottom of the scope cabinet and the syringe used to inject salineduring bronchoscopy. None showed any growth.
On Sept. 17, 2001, the EIS officer arrived to assist with theinvestigation. The EIS officer had heard of contamination of biopsy ports atanother facility, so Jayesh A. Patel, MD, the hospitals infectious diseasephysician and chairman of the infection control committee, was able to twist thecap off a biopsy port on one of the two scopes in question. The cap, however, was designed to be permanent and notremovable by hand.
Cultures taken from the inside of the cap and from the biopsyport of both implicated scopes revealed P. aeruginosa and S. marcescens. The scope manufacturer was notified and the scopes wereremoved from service on Sept. 18. Even after being run through thewasher/disinfector three times with the cap removed from the biopsy port, someof the cultures still grew P. aeruginosa.
Loaner scopes from the manufacturer were received, cultured toensure no contamination, and then put into use on Oct. 3. Two other scopes were received in mid- October; one of thesewas found to have a removable cap later that month. The manufacturer wasnotified and the scope was removed from use. The second scope later grew thesame Pseudomonas strain andwas removed from service. The Food and Drug Administration (FDA) receivedmandatory notification from the state EIS officer by phone, and Mayernick spokewith the local FDA officer and submitted the necessary paperwork. Themanufacturer dispatched its director of microbiology to the hospital to reviewits cleaning and disinfection practices; they then instituted a nationwide recall of 15 models ofbronchoscopes that had a design element involving a biopsy port cap that wasdesigned to be non-removable.
The first thing we did was review our cleaning procedures,because thats what you always think about with bronchoscopy, Mayernickremembers. Scopes are hard to clean, and so you want to make sure you doeverything you can to clean them appropriately. We went over our policies andprocedures, didnt see anything wrong, and the director reviewed the cleaningprocedure with the staff. We didnt find anything wrong with that.
As more positive cultures were found, the hospitals staffbecame more perplexed so many potential sources of P.aeruginosa had been tested, but the source remainedelusive. We were ready to close our endoscopy lab, because we knew there wasa problem, but we just had not found it, she adds. That led to her call tothe state health department.
An urgent recall was sent to hospitals that had the pertinentmodels, but Mayernick says, the wording of the letter could have been better.At the time, they implied that it may have been due to our cleaningprocedures, she says wryly. When the expert [from the manufacturer] cameout, she didnt see anything that contributed to the outbreak.
Johns Hopkins Hospital in Maryland had provided an incorrectaddress; the proper department did not receive the recall letter in the firstmailing. The hospital continued using the affected endoscopes, not knowing theywere exposing patients to P. aeruginosa, and the outcome was twolives.
The main thing with scopes is pre-cleaning and making sureyour machine is working properly, Mayernick stresses. The first thing youshould always do is review your cleaning procedures. Change the filterperiodically. The pre-cleaning is so important, because things can dry on there.Weve always been complimented on our pre-cleaning procedures when we sendscopes out for cleaning.
After extensive investigation, it was found that amanufacturing change in 1997 had led to the change in the biopsy port housing. Aremovable cap was screwed on and fixed with adhesive to ensure that it was nolonger removable. However, some not all of the affected models hadinsufficient adhesive to place the cap permanently on the port housing.
After discovering the source of the problem, the infectioncontrol team at Skyline researched how they might clean the scope with the capremoved. After three sessions through the entire cleaning process, pseudomonasstill remained on some parts of the scope even with particular attentionpaid to those areas.
Mechanical cleaning of the hidden contaminated surfacescould not be accomplished with caps in place, Mayernick explains. Disinfection requires approved disinfectant for a specifiedperiod of time. The loose port caps may have created air pockets that preventedeffective contact between the disinfectant and microorganisms. Also, drying isrequired to prevent microorganisms. The biopsy port caps might have preventedthorough drying of surfaces inside the caps.
The microorganisms origin remains elusive; it may haveoriginated from a patient, from the scope-cleaning sink, or from any number ofsources. Pseudomonas growswell in water, in sinks, in faucets and so forth; thats why you do thecleaning processes. Regardless of whether it came from a patient, the problemwas that you couldnt adequately clean the scopes with caps in place, sheadds. Mayernick emphasizes that all of the positive cultures werefrom two new bronchoscopes the hospital had received in July 2001. There was no contamination associated with our oldernon-video bronchoscopes, she clarifies.
William Schaffner, MD, professor and chair of the VanderbiltUniversity Medical Center department of preventive medicine, co-authored the NewEngland Journal of Medicine article with Mayernick,David L. Kirschke, MD, and others. Youll recall that in manyoutbreaks, the outbreak is a consequence of something that occurs within anindividual institution. This outbreak was detected and obviously occurred in anindividual institution, but as a consequence of a manufacturing defect, hesays. The hospital did what every book says you should do they called forhelp. They called the Tennessee Department of Health and they askedfor assistance. Thats how I entered, because Im a consultant to thatdivision.
After quick discussion, they sent out Kirschke, an EISofficer, to assist in the investigation. However, Schaffner recalls, We had great concerns about howthe company and the FDA responded to this problem. I think it is fair to saythat our concerns about these issues continue to this very moment.
He clarifies, I do not believe that the FDA which hashad a lot of problems recently has the resources or personnel to changetheir approach materially since that time to this kind of issue. But the companyinitiated a worldwide recall of these devices and corrected them, and I believethem I would just like to see more documentation.
Schaffner questions the potential response if such an outbreakshould occur again. If something similar happened tomorrow with anothermedical device, Im afraid that the energy for response remains substantiallywith the company in these kinds of circumstances. The FDA depends upon thecompany to respond. From my personal point of view, thats not a comfortingnotion. I think that the FDA ought to be empowered and funded to be much moreassertive. They depended entirely on the company and we thought the companycould have responded more openly and aggressively in the recall. I dont wantto keep hitting this specific company over the head. As far as I know, theyhavent had any problems since. But if this were another company, the FDAwould depend on the company to define the problem and solution and act on it,and they depend on the company to communicate with the users of the product.That puts a huge amount of responsibility on the company, he points out.
When it comes to medical devices, the FDA has a much lesselaborate program than they do for drugs and vaccines, and that has always beenthe case. I think some of that is the law; some of that is FDA tradition,the way theyve chosen to operate; and some of it is that the FDA isunderfunded in this area. Ive said from the beginning, if we have enhancedexpectations of the FDA, as I do, I have to be willing to give them moreresources, and I am.
Raise my taxes, give them the resources they certainlyneed a lot more resources. When it comes to pharmaceuticals, its clear thatwe as a society were not giving them enough resources. If we want a vigorousFDA, we have to fund it and give them appropriate legal authority, Schaffnerconcludes. Responding to an article that had been written in 2002 aboutthis outbreak, the manufacturer wrote to clarify several errors that wereincluded in the original story.
The article repeatedly refers to a design flaw or designerror in certain Olympus bronchoscopes, wrote Laura Storms-Tyler, director of regulatory affairs andquality assurance for the Medical Systems Group at Olympus America Inc. Thebronchoscopes were recalled because of a manufacturing non-conformance in theamount of adhesive-sealant and torque used to secure the biopsy port in place.Olympus determined that on some instruments, an inadequate amount of this adhesive-sealant andtorque was applied during the manufacturing process, allowing this part toloosen. As soon as Skyline Medical Center (officials) discovered this looseport, and Olympus determined that there was a potential for the biopsy port toloosen on bronchoscopes at other sites as well, Olympus initiated a voluntary,nationwide recall of all affected models, she adds.
The part is not a valve, but a cover or housing thatsurrounds the biopsy port. There was no delay in informing FDA about either theunfolding events at Skyline, or the initiation of the recall mailing. The momentwe learned of a single set of circumstances involving our bronchoscopes at onehospital, we began an immediate inquiry that led to a voluntary nationwiderecall, Storms-Tyler elucidates. In accordance with the Medical DeviceReporting regulations, Olympus informed FDA of the data it had availableregarding the Skyline incident on Oct. 17, 2001. In mid-November, Olympusconcluded that the potential for a loose biopsy port was not isolated to thebronchoscopes at Skyline Medical Center, and decided to initiate a nationwiderecall. The investigation into the incident at Skyline Medical Center was notconcluded until mid to late-November. Certified recall letters dated Nov. 30,2001 were sent out on the following Tuesday, and the FDA was informed of thisrecall action.
In the initial recall letter, dated Nov. 30, 2001, weclearly stated If you detect any looseness in the biopsy channel port, pleasediscontinue use of this bronchoscope, and return the bronchoscope to Olympusrepair facility as noted below. Storms-Tyler continues. It did indicate that if nolooseness is detected in the biopsy channel port, you may continue to utilizethe bronchoscope. However, Olympus would like you to return the bronchoscope atyour convenience so that we can upgrade the biopsy port housing. Althoughthere was no indication at that time, and to date there still is no evidence,that instruments with tight biopsy ports pose any contamination risk, Olympusnevertheless instructed users to return these instruments to Olympus at theirconvenience. The second notice, dated Feb. 27, 2002, sent to those which had notresponded to the first letter, reiterated that even if no looseness isdetected in the biopsy channel port, you are still required to return thebronchoscope so that Olympus can upgrade the biopsy port housing. As of July31, 2002, 97 percent of the units have been returned to Olympus America,modified and returned to the customers. We have had telephone contact with 100 percent of thepurchases of record of the remaining units, and we are working aggressively toensure the remaining units are returned and repaired.
1. Kirschke D, et al. Pseudomonasaeruginosa and Serratiamarcescens Contamination Associated with aManufacturing Defect in Bronchoscopes. N Engl J Med 2003;348:214-220
AN INACCURATE MAILING ADDRESS mayhave led to a second outbreak of Pseudomonas atJohns Hopkins Hospital, several months after the first one at Skyline MedicalCenter. Not all facilities using the affected models of bronchoscopes receivedthe first notification of recall; the letter to Johns Hopkins, for example, wassent to a loading dock at the facility and took several weeks to be routed tothe pulmonology department. The manufacturer maintains that they sent the letterto the address provided by the facility.
The hospital had noted a rate of pseudomonas that was much higher than normal and instituted aninvestigation to determine the cause; the staff was puzzled, just as at Skyline,no Pseudomonas was found inany of the cultures taken from the involved bronchoscopes, items used to cleanthem or the areas where the bronchoscopies were performed.
By early February 2002 the concerns about infection hadbeen raised on Dec. 31, 2001 the staff had determined the source ofinfection, pulled the bronchoscopes out of service for intensive cleaning, andcorrected the problem before resuming elective bronchoscopies afterapproximately two weeks. The source of the problem was the same as at Skyline a loose cap on a port of the bronchoscope. At the same time, in early February, the hospital became awareof the nationwide recall notice, immediately returned all but one of thebronchoscopes to the manufacturer and offered the remaining scope to the FDA forreview.
The hospital then instituted a thorough review of patientrecords and determined that approximately 100 of 410 scoped patients had testedpositive for exposure to pseudomonas, a two- to three-fold greater incidencethan expected for this organism in the patient group.1
However, it was likely that some of these patients becauseof their high-risk background with cystic fibrosis, HIV/AIDS, lung transplantsand cancer might have already carried the pseudomonas bacteria beforeentering the hospital for their bronchoscopies.
Infections related to the outbreak may have been a factor inthe deaths from pneumonia of two patients who were already critically ill at thetime of their bronchoscopies. However, there can be no definitive link made between theoutbreak and the deaths due to the patients already compromised state ofhealth.
A second paper published in the same issue of the NewEngland Journal of Medicine as the Skyline articleaddressed the Johns Hopkins outbreak. The authors concluded their paper with apointed commentary on the current recall procedures required by the FDA, saying,Instrument safety and surveillance methods for bronchoscopy must be improved,and better recall procedures are needed for medical devices.2
They noted in their paper that two of the recalledbronchoscopes had been put into service in mid-June 2001, and that all recalledbronchoscopes were removed from service on Feb. 6, 2002. Outbreaks such asthis one have led patients and physicians to question the safety of bronchoscopy a concern that is receiving heightened attention with the increased focus onpatient safety, they wrote. This outbreak emphasizes the challenges thatnew forms of technology present with respect to adequate reprocessing ofinstrument and the importance of appropriate instrument design to adequatedisinfection, since a loose part may have been the cause of the contamination.It remains to be seen whether the use of instruments such as sheathedbronchoscopes will protect patients from infections due to contaminatedinstruments. In the meantime, perhaps new standards should be developed to testand review the design of instruments with respect to disinfection before theseinstruments are used in patients.
Finally, they said, Our findings arouse concern about theadequacy of nationwide recalls of medical devices. Currently, the Food and DrugAdministration relies on manufacturers to take full responsibility forproduct recalls, including follow-up checks to assure that recalls aresuccessful ... A federal mandate that recall notices be sent to allphysicians who may use a device could have shortened the duration of theoutbreak we studied, decreasing the number of patients at risk. Such a measuremight help ensure that future recalls are handled expeditiously and thus optimize the safety of medical equipment.
2. Srinivasan A, et al. An Outbreak of Pseudomonasaeruginosa Infections Associated With FlexibleBronchoscopes. N Engl J Med 2003;348:221-227.