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Synthes Distributes New Sterilization Guidelines

Submitted by Daisy McCarty

May 24, 2009

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In February, Synthes sent out a notification letter to users of its medical implants, instruments and cases. The company recently re-evaluated the sterilization guidelines associated with the use of their devices. Now, to provide a greater sterility assurance level (SAL) the recommended cycles are based on worst-case scenarios. Parameters for pre-vacuum cycles are set at a minimum of 4 minutes. Temperatures must be at least 270 degrees faranheit and the dry time should be 20 minutes or more. The resulting overkill guards against contamination and is based on AAMI performance expectations outlined in ST77:2006 and TIR12:2004.

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Complex Instrumentation Requires Extended Sterilization Cycles

Submitted by Ken McCarty

May 21, 2009

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Steam sterilization times have increased over the years as medical instrumentation has become more complex. Lumens imbedded in newer devices require lengthy exposure for the sterilizing media to properly decontaminate them. These instruments feature tiny tubes and crevices that are hard for steam to penetrate. The Association for the Advancement of Medical Instrumentation (AAMI) continues to adjust their guidelines and recommendations regarding cycle times for the sterilization of complex instruments. These also apply to combination loads. The Technical Information Report (TIR) 31 has been updated this year so that manufacturer recommendations for various devices requiring longer cycles are consistent.

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Rising Concerns Over Sterilizer Wet Loads In 2009

Submitted by Daisy McCarty

May 20, 2009

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The issue of steam sterilizer wet loads isn’t new, but it has been getting a lot of attention lately. A number of pertinent articles have reached the autoclave community so far this year. Sterilizer manufacturer ETC issued helpful technical information this month. Healthcare Purchasing News also featured a piece on wet packs complete with advice from many industry professionals on solving this persistent problem.

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AAMI Releases New Sterilization Manuals

Submitted by Daisy McCarty

May 15, 2009

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The Association for the Advancement of Medical Instrumentation (AAMI) has just made two updated sterilization manuals available. These latest editions provide comprehensive information regarding processing and standards. Only the first 2 volumes of the 3 volume series have been reissued at this time. They can be purchased in printed form or on CD.

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Update Concerning Solar Autoclave Challenges

Submitted by Ken McCarty

May 14, 2009

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Autoclaves

Salud de Sol is an ETHOS group sponsored by the University of Dayton and winner of $10,000 in a 2008 business plan competition. This organization is requesting advice and ideas concerning a few technical problems associated with building a viable solar autoclave. Their humanitarian project is currently being continued from last year. The team of engineering students started a non-profit organization with a clear intent to help third world communities improve local healthcare. Salud de Sol hopes to achieve this by providing a cost effective method for sterilizing medical instruments.

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More Autoclave Purchasing Issues Plague Philippines

Submitted by Daisy McCarty

May 11, 2009

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Still reeling from an autoclave purchasing scandal last fall, Southeast Asia is now desperately in need of units to treat highly infectious medical waste. The 100 million pesos set aside by the Philippine congress would allow hospitals across the country to safely dispose of these hazardous materials. The National Center for Health Facility Development has already selected locations for the sterilizers. Each medical center equipped with an autoclave would be able to serve several hospitals in its vicinity.

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Solidworks Offers Custom Autoclave Design Capability

Submitted by Ken McCarty

May 10, 2009

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Autoclaves

Building better equipment requires creative initiative. It is much easier for engineers to make designs more efficient if they have the right tools to generate and manipulate their new ideas. ESTS (GB) Ltd, an established manufacturer of autoclaves and sterilizers, has recently upgraded their design computer software to Solidworks. This is a new 3D CAD program supplied by Innova Systems.

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LTE Scientific Presenting Touchclave Autoclaves At Achema

Submitted by Daisy McCarty

May 8, 2009

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LTE has a number of events on its calendar for 2009. Next week (May 11-15) they will be participating in the ACHEMA tradeshow in Frankfurt Messe. This international meeting happens only once every 3 years, so there are sure to be quite a few new technologies on display. A wide variety of process industries including pharmaceutical and biotechnology will be represented at ACHEMA. Over 4,000 exhibitors will fill the halls at this enormous event. LTE will be one of about 400 British companies making the trip to Germany to attend. Their line of Touchclave autoclaves will be of interest to large and small customers alike. Units in the LTE line of products range in size from 40 liters to over 1000 liters.

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Sterilizer Maintenance – Scant Record Keeping Raises Concerns

Submitted by Daisy McCarty

May 5, 2009

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Medical institutions such as V.A. run hospitals have come under fire recently for failure to follow appropriate sterilization protocols. Canada is receiving similar attention now in a consumer health scare that affects clients in a very different setting. A Mississagua tattoo parlor was recently investigated for failing to keep thorough records regarding the maintenance of its sterilization equipment. Health inspectors visited the business shortly after it opened in 2005. Over the next several years, no further contact was made. Officials from the health department state lack of resources as the cause for skipping a number of yearly inspections. Upon their second visit to MoonShin in February of 2009, inspectors were not satisfied with the minimal records presented regarding sterilizer maintenance.

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Hameln Pharma Selected For Top Sterile Processing Award

Submitted by Daisy McCarty

May 3, 2009

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Autoclaves

The International Society for Pharmaceutical Engineering and the Pharmaceutical Processing Journal have announced the winners of the first round of “Facility of the Year” awards for 2009. The Operational Excellence nod goes to Hameln Pharma – a German manufacturing firm. This recognition spotlights the company’s new sterile processing plant that just opened in the spring of 2008. It has quickly risen to become one of the best aseptic manufacturers in its field. The plant garnered high praise for its low cost, streamlined design. It was also commended for being up to date with all relevant regulations. Construction of this location was accomplished in 25 months – quite an achievement for a project of this scope.

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