March 4, 2002
MEDIA CONTACT: Elaine Freeman
PHONE: 410-955-6680

EDIA CONTACT: Gary Stephenson
PHONE: 410-955-5384

Defective Bronchoscopes Identified as Probable Cause of Infections Are Part of Manufacturer's National Recall

Hopkins Launches Effort to Contact, Evaluate All Potentially Exposed Patients

Johns Hopkins has initiated an aggressive campaign to contact all of its patients who may have been exposed to bacteria due to defective bronchoscopes that are part of a national recall by the manufacturer. The patients, all adults, are being offered free evaluation and testing, and they and their physicians are being asked to be especially alert to symptoms of infection, such as fever, coughing, increased phlegm (sputum) or increased shortness of breath. At the same time, Hopkins physicians are trying to heighten awareness among their colleagues nationwide of this problem and of more aggressive measures that need to be taken to confirm the source of infection.

The group of approximately 410 Hopkins patients underwent a diagnostic procedure called bronchoalveolar lavage (BAL) between June 1, 2001 and Feb. 4, 2002. The procedure allows physicians to view the insides of the lungs and extract specimens to confirm or identify lung infections. Many of the patients were critically ill at the time of their procedure, all of which took place in the same endoscopy lab in the hospital.

Identification of the defective bronchoscopes as the source of an unexpectedly high rate of pseudomonas aeruginosa infections among these patients came about through determined detective work by Hopkins Hospital pulmonologists and infection control experts before they learned of the manufacturer's recall.

On December 31, the pulmonologists raised concerns about unexpected rates of pseudomonas infections in several very sick and immune compromised patients. The hospital‘s infection control staff, in conjunction with the pulmonologists, immediately launched a comprehensive environmental review of the bronchoscopes, the equipment and fluids used to clean them, the areas where the procedures were performed and the instruments were stored, and all the processes and procedures associated with their use. No pseudomonas was found in any of these cultures, leaving the staff perplexed.

At the end of January, someone suggested testing the bronchoscopes by flushing fluid through them in the reverse direction from the industry standard. This retrograde flushing revealed the contamination which Hopkins doctors believe is related to the loose port on the bronchoscope that is the subject of the nationwide recall.

As a result of this intensive examination, by early February bacterial contamination was confirmed in three of seven bronchoscopes used for examining these patients and manufactured by Olympus America Inc. All elective bronchoscopies were cancelled for about two weeks, from Feb. 4-18, and the defective scopes removed from service. When it was determined that the problem had been corrected and that bacterial contamination from bronchoscopes no longer posed a risk to patients, the procedures were resumed.

Coincidentally, in early February, Hopkins became aware of a national recall notice sent out by Olympus earlier to hundreds of hospitals. The notice was prompted by a report from another medical center of bacterial contamination in its bronchoscopes. In its recall notice, Olympus noted that a loose port on certain bronchoscopes might have permitted the contamination to occur. Four of the seven scopes used by Hopkins, including the three in which contamination was found, were subject to this recall. Hopkins immediately returned all of the bronchoscopes covered by this recall, except one that was retained and offered to the Food and Drug Administration (FDA) for review.

In addition to the environmental review, Hopkins began a comprehensive review of the patients' medical records. Preliminary findings indicate that around 100 of the approximately 410 patients in the group have tested positive for exposure to pseudomonas, a two- to three-fold greater incidence than expected for this organism in this group of patients.

Hopkins physicians caution that even though patients may have been exposed to the bacteria by the defective instruments during their medical procedures, not all will become infected. Furthermore, given the nature of their illnesses (cystic fibrosis, HIV/AIDS, lung transplants, and cancer), it is likely that some of these patients carried the pseudomonas bacteria before they came to Hopkins for their bronchoscopies.

Infections related to the contaminated scopes may have contributed to the deaths from pneumonia of two already critically ill patients. However, determining cause and effect is complex in this group of extremely sick patients among whom some deaths are to be expected due to the severity of their illness. In sum, Hopkins' review has revealed serious infections which it believes are related to the defective bronchoscopes, but more work needs to be done to pin down the precise nature of the relationship.

Because the well-being of patients is the first priority at Hopkins, physicians are calling all of their patients who have undergone bronchoscopy in the hospital's endoscopy suite since June 1, 2001, a month before the period when the infection rate showed a statistical increase. In addition, certified and first class letters are being sent to all of these patients and their physicians. Special telephone lines have been set up so that these patients can arrange for appointments to be evaluated at no charge (410-955-0272) or to get more information (1-800-347-8615).

Additional information about this situation may be obtained from the FDA's information officer for medical devices, Sharon Snyder, at 301-827-6247, and from Diane Denton, 615-741-3111, the information officer at the health department in Tennessee, the state where the contamination that led to the initial recall notice took place.

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