Author: Ken McCarty

Case Medical’s Steri Tite Gains Additional FDA Clearance

Submitted by Ken McCarty
March 16, 2009

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On December 5th 2008, Case Medical’s Steri Tite and Medi Tray products were given an additional FDA 501k clearance. This means that the equipment can be marketed for use with a much wider variety of sterilizer models associated with Flash Sterilization. The company’s products were already being sold for use with pre vacuum and gravity steam sterilization, Ethylene Oxide, STERRAD 100, 100S, and sealed flash using their Flash Tite valve plate. It is now being recommended by the manufacturer for use with the STERRAD 200, STERRAD NX, ozone 125L, and pre vacuum flash using a qualified disposable filter.

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Author: Daisy McCarty

Sheikh Zayed Hospital Now Autoclaves Highly Infectious Medical Waste

Submitted by Daisy McCarty
March 14, 2009

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In January, the Sheikh Zayed Hospital became the second medical facility in Pakistan to build/install an autoclave for disposal of highly infectious medical waste.  Steam autoclaving will now supplement incineration and chemical disinfection as the method of choice for this process.  However, the equipment will have a hard time keeping up with the current workload at this busy facility.

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Author: Ken McCarty

CYCLESURE Biological Indicator Now Twice As Fast!

Submitted by Ken McCarty
March 9, 2009

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Advanced Sterilization Products is a division of the Ethicon Inc. (a Johnson & Johnson Company).  They announced in January of 2009 that their STERRAD® CYCLESURE® biological indicator design has been significantly improved.  Incubation times have been reduced from 48 hours to only 24.  The faster readout results from the tests mean faster turnaround for whole sets of instrument inventories.

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Author: Ken McCarty

ASTM Workshop Discusses Low Energy Electron Beam For Pharma

Submitted by Ken McCarty
March 8, 2009

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Any object being sanitized needs to be isolated. For this reason, electron beam emitters that help segregate and disinfect at the same time are rapidly becoming more common. This is especially true in Europe where the first unit went on-line in a manufacturing environment in 2002. Today, there are many of these machines around the world.  They are used for sterilization purposes within various industries. One of the big questions these days is: How low of a dose is needed to provide good results? ASTM’s sixth annual international workshop on dosimetry for radiation processing (October 4th 2009 in Karlesruhe, Germany) will focus upon such issues.

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Author: Daisy McCarty

STERIS Liquid Chemical Sterilizer Under FDA Scrutiny

Submitted by Daisy McCarty
March 7, 2009

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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.

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Author: Ken McCarty

Berkshire Sweeps The Globe With Cleanroom Mops

Submitted by Ken McCarty
March 6, 2009

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Decontamination in cleanrooms is an important process for a variety of manufacturing and healthcare related industries.  Berkshire manufactures cleanroom mops (and other products) that are used to maintain high levels of cleanliness throughout critical production or work areas.  Berkshire Corporation will exhibit their cleaning technology at both the Semicon China 2009 and Interphex U.S.A. 2009 in New York between March 17th and 19th, 2009.  Effectively during a couple of days, they are making a clean sweep of the earth in their effort to disseminate information on their company, products, and services.

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Author: Daisy McCarty

TSO3 Investigates Ozone Sterilization To Kill Prions

Submitted by Daisy McCarty
March 5, 2009

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TSO3, Inc. in partnership with the U.K.’s Health Protection Agency is studying low temperature decontamination methods for reusable medical devices. Their ongoing research on the use of ozone sterilization to eliminate prion contamination has now reached another milestone. The HPA uses the TSO3 Sterizone 125L to perform its research. The current method for prion inactivation is via high temperature autoclaving. This means the new equipment’s performance must meet a high standard to be considered effective. So far, the results are hopeful.

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Author: Ken McCarty

New Electron Beam Sterilization For Aseptic PET Bottles

Submitted by Ken McCarty
March 4, 2009

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Sterile products placed in sterile packages greatly enhance the length of time they can be safely stored.  This is especially true for plastics used in the food processing industry.  Ensuring that a PET bottle is sterile is normally done through a flash heat or chemical step in a long process of manufacturing or recycling.  Now, AEB (Advanced Electron Beams) has come up with a compact electron beam emitter that is small enough to be able to quickly enter and exit a plastic bottle.  This means that electron beam sterilization for aseptic PET bottles is now a viable alternative to traditional methods for guaranteed sanitization.

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Author: Daisy McCarty

Case Medical Gets New FDA Clearance For SteriTite Containers

Submitted by Daisy McCarty
March 2, 2009

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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.

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Author: Ken McCarty

Aduramed Patent Application Becomes MedClean

Submitted by Ken McCarty
March 1, 2009

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In November of 2008, Aduramed successfully filed a US Patent on its containerized sterilization process, protocol, and autoclave standard.  The name for the process is MedClean.  Events have progressed rapidly over the last several months.  Effectively, the Aduramed patent application has now become a working MedClean business opportunity.  The company was able to do this because sterilization is not just about the end product, but also about the safe handling of all hazardous medical wastes from start to finish.  In short, it is about safety for all hospital personnel involved with the disposal process.

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