The Food & Drug Administration told hospital administrators across the country to stop using a popular endoscope sterilizer made by Steris Corp. (NYSE:STE) within six months, after the watchdog agency could not verify the safety of the product.
The Steris System 1 processor is typically used in surgical and endoscope suites for sterilizing and disinfecting medical devices.
The edict could mean significant and unexpected costs for healthcare facilities, as they scramble to comply. Jerry Berger, the director of media relations for Beth Israel Deaconess Medical Center in Boston, told MassDevice that it’s impossible to speculate on the exact cost. Berger confirmed that BIDMC has begun making plans to replace their entire cache of the sterilizers, which retail for around $5,000 each. The FDA has said it will not provide any financial assistance to hospitals replacing the machines.
Berger said Beth Israel will comply with the edict and also make sure the Steris systems are safe to use during the transition.
“Our highest priority is patient safety,” he said. “We will do everything in our power to ensure patients will be treated safely.”
The unusual action by the FDA follows more than 18 months of legal wrangling with Mentor, Ohio-based Steris, ending in a de-facto recall of a product that hasn’t been linked to any cases of infection or injury.
The Centers for Devices and Radiological Health issued a stakeholders letter to hospital administrators Dec. 4 about the Steris System 1 processor. The agency said Steris made significant modifications to the SS1 device over a 14-year period without seeking additional 510(K) clearance, in violation of the original 1989 indication for the device. It’s primarily used to sterilize endoscopes between procedures, replacing the more time-intensive practice of soaking instruments in toxic chemicals such as glutaraldehyde.
In May, 2008, the FDA issued a warning letter to Steris saying the modifications could significantly impact the safety or effectiveness of the device. After several meetings, Steris agreed to work with customers to help them transition to “legally-marketed alternatives.”
In January, Steris sent a letter to customers informing them that the FDA was requiring the company to file another 510(k) covering the modifications, saying it would discontinue sales of the product but continue to service models it had already sold. The company denied the FDA’s claims that modifications made on the machine from 1988 to 2002 required further regulatory action.
But the FDA said Steris continued to assure customers the units were safe and continued to sell new units, prompting the agency to act more aggressively and actively advise hospitals to switch to competing devices, a potentially huge boon for competitors like Advanced Sterilization Products, the Johnson & Johnson (NYSE:JNJ) division that makes the Sterrad sterilization system.
For its part, Steris defended the SS1, writing in a Dec. 7. response letter to customers that the “System 1 processor has been safely used for more than 300 million cycles over more than 20 years.”
Shares of Steris stock have fallen about 18 percent since the close of market Dec. 3, from a high of $33.65 to $27.20 as of about 2 p.m. Dec. 11.
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