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Sterility of Norplant packaging [letter]

Author: 
Reynolds RD
Source: 
JAMA. 1991 Nov 6; 266(17):2373.
Abstract: 

Evidence is presented of a potentially serious perception problem concerning the sterility of the Norplant packaging. The insertion kit consists of an outer cardboard box with an inner plastic tray that holds the individually wrapped, sterilized insertion materials. Also included is a sterile towel intended for use as a side table sterile field. At a physician training session conducted by Norplant's manufacturer, Wyeth-Ayerst Laboratories, the author observed the trainer to use the nonsterile plastic tray as a sterile field to lay out the insertion materials. The trainer reportedly had been taught this procedure at a seminar for trainers. The manufacturer's audiovisual materials and package insert outline the need to unwrap all insertion materials into a sterile field. All physicians, especially those who have attended trainings, should be aware of the nonsterile nature of the plastic tray. Both the Food and Drug Administration and the manufacturer have been informed of this perception problem.

Language: 
Year: 
Region / Country: 
Document Number: 
068872
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