January, 2004

Dear Valued Customer,

This section of the web site has been put together to address the issue of patient safety as it pertains to care and maintenance of LMA™ airways.

This year I have required that our sales representatives make sure our customers are reminded about the correct cleaning, sterilization and tracking procedures for our reusable LMA™ airways. We have found that the majority of product issues reported are the result of improper customer handling and processing.

The Laryngeal Mask Company, our manufacturer, warrants reusable LMA™ products against manufacturing defects for 40 uses or a period of one (1) year from date of invoice, whichever comes first. The instruction manual states, "With proper cleaning, sterilization, and handling the reusable LMA™ airways can be used a maximum of 40 times." The manufacturer can accept no liability for failure beyond 40 uses.

Our packaging is clearly labeled in several places with a do-not-exceed 40 use symbol. We believe the 40 use guideline, which is based on the manufacturer's test results, is a reasonable limit with a sufficient margin of safety, provided the product passes all performance tests prior to use. It is also a good value when used 40 times

This information answers three important questions:

1. What are the risks involved with overuse, failure to track the number of uses, and improper cleaning and sterilization?
2. What needs to be done to mitigate those risks?
3. What will it cost to achieve 40 Use compliance?