Updated 8:22 p.m.
MENTOR, Ohio — FDA to endoscope manufacturers on Monday: If you have labeled your devices for use with the STERIS Corp. System 1 sterilizer, your devices are misbranded.
In a Feb. 22 letter, the U.S. Food and Drug Administration warned makers of endoscopes to change their labeling as soon as possible if they recommend using System 1 to sterilize their devices after use.
But in a Tuesday email to the same device makers, the FDA seemed to recall its Monday letter as premature:
“Dear Colleagues: The letter provided as a link to FDA’s webpage has been sent to advise endoscope manufacturers to remove references to the [STERIS System 1] from their product labeling and to assure that their labeling specifies only legally-marketed reprocessing devices. No action is required by healthcare facilities in response to the letter. Please disregard the previous posting and e-mail dissemination of this letter; it was premature.”
STERIS executives are confused by the FDA’s recent communications, and so are some of its customers, said Stephen Norton, corporate communications director for the Mentor, Ohio, maker of infection protection, decontamination and life science technologies.
“We’ve called FDA” but had not received a clarification by Wednesday evening, Norton said. “Right now, we are suggesting endoscope manufacturers direct their questions to Candace McManus,” the FDA official to whom questions were directed in the regulator’s Monday letter, he said.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Since December, the FDA has considered System 1 a “violating device.” On Dec. 3, the FDA warned that the chemical sterilizer for medical instruments like endoscopes no longer had the administration’s approval as safe and effective because STERIS had significantly changed the device since its 1988 launch. STERIS has said changes made to System 1 through the years did not warrant new market approval, and the company complied with FDA requirements while making the changes.
On Feb. 2, the FDA updated its safety alert, suggesting hospitals and other health care facilities replace their System 1s with alternatives within 18 months. In December, the administration said this transition should occur within six months, however, it realized the short transition period “may represent significant difficulties for some health care facilities, which could, in turn, adversely affect patient care,” according to a release.
That day, STERIS reported higher operating profits and a modest increase in revenue for its fiscal third quarter over the year-ago quarter. At the same time, STERIS said its future profits are unclear because it has been unable to resolve problems the FDA has with its System 1 sterilizer.
“The uncertainty surrounding our System 1 product … continues to be a complicated matter, and we have been in frequent communications with the FDA in the past several weeks,” Walt Rosebrough, president and chief executive of STERIS, told securities analysts during a Feb. 2 conference call.
“Our goal is to have a plan to assist health care facilities as they look to transition to acceptable alternatives to STERIS System 1,” Rosebrough said. “In the meantime, we continue to support current System 1 users by providing sterilant, accessories, parts and service.”
Because of the uncertain market for System 1 supplies, parts and service — which typically account for 10 percent of STERIS revenue each year — the company declined to provide sales and income guidance for fiscal 2010, ending in March.
