by
Sean Ruck, Contributing Editor | March 10, 2012
Clarification for some of these concerns is available from the FDA. According to information posted on the FDA’s website, since no adverse effects were reported due to use of the device, facilities are not required health care providers to inform patients of the use of the SS1 during or after a procedure.
Still, the discrepancies of the FDA’s message and actions have caused concern among medical professionals and even among the public.
STERIS meanwhile, worked with customers to help them transition to approved products. This didn’t sit well with some customers. Some health care providers demanded a refund on the device(s) they purchased and in some cases, turned to the courts to try to plead their case. At least two class action lawsuits were filed with the company settling one in June of last year to the tune of $20 million.
Due to the controversy, the voluntary discontinuation of a popular product and the wariness of the market, STERIS’ stock took a hit. However, the company has reported recent growth and fourth-quarter profits are expected to rise still further.
Next for STERIS
The company offers hundreds of products, so although significant, the loss of income from the SS1 is not crippling. On April 7, 2010 STERIS received 510(k) approval of the SYSTEM 1E Liquid Chemical Sterilant Processing System sans a biological indicator. The system is the only one on the market using the liquid chemical sterilant processing technology; therefore, even with past controversy, facilities are looking at the device as a way to process their heat-sensitive medical devices.
What's next for customers
If your facility is still using the SS1 there are some important facts to note.
- Transition from the old system to an approved system must occur by August 2, 2012.
- To continue to receive support for the system up until August 2, 2012, a Certificate of Transition Form needs to be completed and returned to STERIS
- You must provide the purchase order date and proposed installation date for an approved product as part of the Certificate of Transition. The product does not need to be a STERIS product.
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