Hospitals Need To Replace The Steris System Endoscope Sterilizer in 6 Months – FDA Mandate
Posted Dec 11 2009 9:23pm
Just a few days ago I made the comment relative to budgets and said ask a hospital CEO what it is like to budget for things are exist tomorrow that are not here today, well this is pretty close, as an unexpected expense. The safety and effectiveness of the sterilizer can’t be verified, so out they go and hospitals buy new ones.
Anyway, this is a bit of a boom for competitor Johnson and Johnson as the agency has begun recommending the purchase of their product for a replacement. BD
As mentioned below, FDA provides no financial assistance, the hospitals eat it. In the last year, the VA has been in the news about sterilization a few times with people being tested for hepatitis and HIV exposure, so there’s no choice here at all.
The Food & Drug Administration flexes its new muscles, forcing hospitals to stop using Steris Corp.'s endoscope sterilizer within six months.
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.
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.