Olympus America: Recall Q&A
(Editor’s note: Olympus America in Melville, NY, submitted the following answers to Hospital Infection Control questions about its recall of bronchoscopes. The material is edited for space and editorial style. Emphasis and underlining are by Olympus.)
Q. What is the recall status? How many units have been repaired, and how many are still outstanding?
A. As of May 1, 2002, 94.6% of the units have been returned to Olympus America, modified, and returned to the customers. We have had telephone contact with 100% of the purchasers of record of the remaining units, and we are working aggressively to ensure the remaining units are returned and repaired.
Q. Regarding the nature of the recall, some have accused Olympus America of not being aggressive with the recall. Johns Hopkins has indicated that its recall notice was sent to the wrong address.
A. 1. The health and safety of patients is the primary concern of Olympus America. When we learned of a single set of circumstances involving our bronchoscopes at one hospital, we initiated an investigation that determined an occurrence of a loose biopsy port on our bronchoscopes. When that investigation indicated that there was a probability that there could be loose ports on other bronchoscopes, we initiated an immediate, voluntary recall.
2. The recall letters sent to Johns Hopkins, as with every customer, were sent to the address the customer provided to us when they purchased their instruments. The recall letters were sent via certified return-receipt mail, addressed to the attention of the Bronchoscopy Lab Manager/Risk Manager with "URGENT RECALL" printed in large capital letters on the envelope and atop the first page of the letter.
Q. Did you tell customers to return the devices "at their convenience"?
A. Please review our recall letters. In the initial recall letter, dated Nov. 30, 2001, we clearly stated, "If you detect any looseness in the biopsy channel port, please discontinue use of this bronchoscope, and return the bronchoscope to Olympus’ repair facility as noted below." It did indicate that if no looseness is detected in the biopsy channel port, you may continue to utilize the bronchoscope; however, Olympus would like you to return the bronchoscope at your convenience so that we can upgrade the biopsy port housing." The second notice, dated Feb. 27, 2002, indicated that even, " If no looseness is detected in the biopsy channel port, you are still required to return the bronchoscope so that Olympus can upgrade the biopsy port housing."
Q. Does Olympus America believe this situation will change the way recalls are done?
A. Olympus would support the development of a working group composed of industry, the Food and Drug Administration, and health care organizations to develop a rapid, efficient system for recall communication.
Q. Was this corrective action a design change for the scopes?
A. We do not consider the corrective action to be a design change. The original design was not defective. The recall was initiated because of a variation in the amount of adhesive-sealant applied to the threads of the biopsy port. The corrective action involved securing the biopsy port with the correct amount of adhesive and applying a specific tightening torque during the repair process. The biopsy port was changed from plastic to stainless steel so that the tightening process would not damage the port.
Q. How will Olympus make sure the biopsy port will not become loose again?
A. Olympus tested and validated the corrective action, and we are confident that the repairs we made will ensure the security of the biopsy port.
Q. In your original recall letter, why did the company cite that the hospital failed to maintain the auto-mated endoscope reprocessor (AER) to the manufacturer’s labeling? (Investigators claim this had no bearing on the contamination of the scopes.)
A. Our investigation indicated that the maintenance of the AER could have been a factor, and we believe the responsible and prudent action was to advise our customers of that information.