STERIS is one of the largest manufacturers of equipment to sterilize medical devices for safe, repeated usage. Since its flagship product, SYSTEM 1, was introduced, thousands of hospitals and clinics across the world have used this sterilization processor to safely and quickly sterilize hundreds of millions of medical devices so they could be used again, reducing the wait time for treatment. Its continued success was in question, however, when the U.S. Food and Drug Administration (FDA) issued a warning letter to STERIS stating that significant changes occurred to the design and manufacture of SYSTEM 1 and its accompanying sterilant beyond the original approval by the government.
As lead agency for the company, Dix & Eaton developed and implemented a crisis management plan that created the larger context of what the FDA had neglected to state in public announcements about the warning letter – that is, what such a letter really means. Dix & Eaton immediately assisted the client in reaching customers to make clear that the warning letter requested additional information from STERIS on any changes made to its product, that SYSTEM 1 remained in safe and effective use by thousands of customers and also remained available on the market. Tactics included a FAQ for customers that answered their questions and a telephone hotline and a Web micro site to provide information. Our messaging focused on the customer: “At STERIS, the highest priority is always patient safety. We take seriously our regulatory responsibilities and we are working with the FDA to respond to its request.“
The initial media coverage, which was particularly extensive in The Wall Street Journal, quickly slowed and disappeared as it became clear that the warning letter was a request for more information, that
the product remained available for use. In essence, the strategy successfully demonstrated that what at first appeared to be a serious safety issue was a not-unusual request from the government and thus a “non-issue.”
Gary Wells, CEO Dix & Eaton, Cleveland, Ohio, The United States
“If you want to redefine the issue, you must reframe the conversation”