In Reply:—
The 10-cm Williams Fiberoptic Intubating Airway is a disposable device manufactured by 349556 Alberta Inc. (Calgary, Alberta, Canada) and distributed in the United States by Anesthesia Associates, Inc., as well as by several other firms. The recent incident, referred to by Drs. Michelsen and Valdes-Murua in their letter, occurred with products that may have been distributed by Anesthesia Associates, Inc.
The products in question were reported to have been pulled from a hospital cart repackaged ziplock bag (not the original packaging) and no longer had any distributor lot number identification attached. However, apparently the bag did contain a copy of an Anesthesia Associates, Inc. product insert titled “Williams™ Airway Intubator.” It has been determined through the obsolete telephone area code shown on the product insert that the insert in question was printed for distribution with products that would have been shipped during the year 1996 or earlier. Although not a substitute for the missing lot number identification, it does indicate that it is probable that the products in question were shipped from our facility in 1996 or before.
It is of note that in 1995, a concern was acknowledged by the manufacturer of the airways (349556 Alberta Inc.) regarding manufacturing mold wear leading to internal “teeth” identical to those described by Drs. Michelsen and Valdes-Murua in their letter. At that time, Anesthesia Associates, Inc. (as well as other distributors of the product) identified the affected lot numbers of all products that exhibited this deficiency. Specific action was taken to notify all affected Anesthesia Associates, Inc. dealers that there was a concern, and it was further requested that all inventories be returned for reinspection. All units returned and found to be deficient were destroyed; however, some dealers had inventory that already had made its way to the end user and had been discarded or lost. No patient injuries or problems were reported from this issue.
The manufacturer took appropriate steps in 1995 to eliminate the deficiency that had been noted. The molds were completely rebuilt to eliminate the existing wear, and more stringent mold inspection criteria were established. Inspection levels for the finished devices were changed from a statistical sampling to a 100% full inspection level to eliminate any question of deficient products. The distributor also increased their inspection level an additional safety check. To date, there have been no known reoccurrences of the issue other than the referenced letter.
From the apparent age (1996 or earlier) of the devices of Drs. Michelsen and Valdes-Murua, it appears that they may have been part of the group of products in 1995 that generated the actions indicated herein. The particular units that they had in their cart most probably circumvented the 1995 retrieval program. The specifics of whether they were in the hospital storage system during this entire period or arrived more recently from a vendor are not known. The concern of Drs. Michelsen and Valdes-Murua regarding the products is understandable, and we applaud their efforts to alert others regarding safety issues. However, we are firm in our belief that this is an isolated event that is a holdover from a previously corrected situation.
