Last year, STERIS Corporation received a wrist slap from the FDA. Concerns were raised about the company’s SYSTEM 1 liquid chemical sterilizer. Quite a number of changes had been made in the product design since it was originally cleared for sale in the U.S. These modifications included switching to a different style of pump and impeller. Alterations were also made to the chamber size and software parameters. The FDA warned STERIS that these changes required a new premarketing clearance. The manufacturer disagreed with this assessment. Compromise with a government agency is generally one-sided. However, the two parties have come to an agreement in this case.
The design modifications were made over a time period encompassing more than a decade. The company had therefore already sold many of these altered units to end users before the warning letter was issued. The FDA determined that any potential problems would not be significant enough to trigger a product recall. Current users of the devices are not advised to change their current procedures for equipment use. However, no more of these SYSTEM 1 models will be sold except to replace units that are already in place. Accessories, replacement parts, and service will still be available until at least 2011 for existing machines.
On January 5th of this year, the manufacturer submitted its new 510(k) premarketing application including up to date information on the latest SYSTEM 1 model. They anticipate that the FDA will give them the necessary clearance for this newest version. After STERIS satisfies the regulatory agency’s requirements, the company plans to transition existing customers to the approved model. The costs associated with commercializing this system are expected to affect revenues in 2010 to the tune of about 10 million dollars. The company describes this impact as “modest” in relation to their overall financial picture. Making adjustments to comply with FDA obligations as they arise is simply another cost of doing business.
Other STERIS Products
Although the SYSTEM 1 is currently off the market, STERIS still has other models available for purchase. The Amsco Eagle 3017 EO sterilizer uses ethylene oxide to process items such as endoscopes that cannot be steam autoclaved. Each unit includes two baskets to hold instruments for processing in the vacuum chamber. Four different cycles come pre-programmed for ease of use. One nice design feature is the single use EO cartridge. It isn’t a particularly “green” consumable, but it does make handling this hazardous material safer for the operator.
The V-PRO 1 is another low temperature system planned with the busy surgical suite in mind. This high volume sterilizer uses vaporized hydrogen peroxide to process medical devices quickly and efficiently. The equipment is programmed and controlled through an easy-to-read digital touch screen. Each cycle can be documented using the integrated printer. Ethernet connectivity also offers the option of remote monitoring.
Whether you need a low-temp gas sterilizer or a piping hot autoclave, you can benefit from reviewing this free report before you buy. It takes only a couple of minutes to read and contains valuable information that will help you accurately assess your needs.