In December of 2008, Case Medical announced that its 510k application with the Food and Drug Administration has been cleared. This allows their SteriTite containers to be marketed for several new uses such as TSO3 ozone 125L, STERRAD 200, and pre-vacuum flash sterilization. 510k premarket notifications must be filed with the FDA at least 90 days before a medical device is introduced to the market. This gives the Administration time to review each new or modified product and classify it appropriately. Because the same SteriTite product was previously approved for other equivalent purposes, the FDA had no problem giving the green light for marketing to begin. The company will, of course, be required to comply with labeling and good manufacturing processes along with other regulations as they proceed.
The SteriTite system provides reusable sealed sterilization cases for medical devices. These rigid containers are vented for full content penetration during sterilizing. Case Medical’s line of MediTray baskets and inserts can be fully integrated with this product. Due to the latest FDA clearance, this packaging is now considered compatible with all current methods of sterilization. This includes both low temperature and steam applications. The containers meet the required specifications for processing endoscopes and other delicate equipment. Validation by independent laboratories has shown that the product achieves a 6-log reduction in living organisms during sterilization. The company hopes that providing this single source solution will prompt consumers to invest in SteriTite for their facilities.
About Case Medical Inc.
This New Jersey manufacturer offers specialty products to the medical industry. Their team of engineers uses computer modeling technology and testing to provide superior outcomes for new applications. The company itself is FDA registered for compliance with ISO 13485. Adaptability and modular designs allow their devices to be used in a wide variety of settings at a reasonable cost. The SteriTite containers come in a variety of sizes and can be color coded for different purposes. Readily available standard components can be paired with these cases and the related MediTray products to secure surgical instruments for sterilization.
The company offers a full line of decontamination solutions. This includes pH neutral enzymatic cleaners that are ideal for use in automated washers or for manual disinfecting routines. Products such as PentaPrep, BioGone, and Super Nova concentrate can be used in conjunction with Case Medical’s brushes and lubricants. Many of these solutions are advertised as hypo-allergenic and environmentally friendly.
This company goes beyond manufacturing, sales, and customer service by offering accredited training courses as well. These online series cover current information regarding instrument processing and include PDF study guides so students have permanent reference materials. Their initial program addresses cleaning as the cornerstone of decontamination. Getting this first step in the process right is the foundation for every subsequent level of disinfection and sterilization. Giving technicians and other personnel access to this valuable information helps ensure a high standard of care for patients. Case Medical also has a free, comprehensive FAQ for SteriTite product use on their website.
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