Author: Daisy McCarty

FDA Mulls Unique Device Identification Question

Submitted by Daisy McCarty
May 31, 2009

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On February 12, 2009, the FDA held a public workshop on the topic of unique device identification (UDI) in the medical community. The Amendment Act of 2007 mandated the use of such identification systems but the practical details are still being worked out. The gathering in February focused on a number of questions that need to be resolved. The eventual outcome should help healthcare facilities fully integrate this device tracking concept into their everyday workflow. Discussion revolved around such issues as where on each device the identifying mark would be placed (a major concern with small items such as needles). Also covered were considerations regarding what information the UDI should contain and how the related databases should be structured and maintained.

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Author: Ken McCarty

Isogen Offers Outsourcing For Sterile Processing Technology

Submitted by Ken McCarty
May 30, 2009

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In January of 2009, Isogen began using its advanced sterile processing technology to help fill a gap in the injectable manufacturing market.  They opened a small scale sterile filling service plant in Delaware to fulfill the needs of the pharmaceutical industry.  It now provides Good Manufacturing Processes (GMP) for vial and syringe filling.  The primary purpose of this new business venture is to meet specific customer requirements in contract manufacturing.

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Author: Daisy McCarty

SixCess Chemical Indicator Can’t Replace Biological Indicators

Submitted by Daisy McCarty
May 29, 2009

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In April, the Certification Board for Sterile Processing and Distribution (CBSPD) issued a helpful news update regarding chemical indicators. One of the organization’s members was concerned that appropriate testing procedure were being set aside in favor of expediency. Nancy Chobin (RN) sent a communication to the FDA to clarify the current standards. In her message, Chobin revealed that several health facilities had been asked to use Class VI indicators to release all load types. This is in contrast to accepted practices of using spore strips to do equipment validation and implant sterility verification.

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Author: Ken McCarty

Sterile Processing Departments Need Informational Resources

Submitted by Ken McCarty
May 28, 2009

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Effective sterilization is a process that starts with the manufacturer. Once the FDA is satisfied with the safety of a new autoclave or sterilizer design, it becomes the end user’s responsibility to ensure proper operation. Outside technicians can be hired to test and repair equipment, but each healthcare facility is charged with the ultimate safety and sterility of instruments. Patients rely on careful and thorough processing of all reusable materials to prevent cross infection.

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Author: Daisy McCarty

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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Author: Ken McCarty

ETC’s Sterilizer Retrofit Project Goes Green

Submitted by Ken McCarty

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There appears to be a lot going on at ETC these days.  Environmental Tectonics Corporation’s Sterilization System Group (SSG) has secured another major contract worth approximately 2.5 million dollars. This sterilizer retrofit project involves refurbishing 12 industrial sterilizers. The units will be fitted with new state of the art control systems, process vacuum piping, and an additional set of chillers featuring an efficient water loop.   This is part of a “green” initiative to make these machines more environmentally friendly. It will also save the customer a substantial amount of money through lower operating and maintenance costs.

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Author: Ken McCarty

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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Author: Daisy McCarty

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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Author: Ken McCarty

Electrolyzed Sterilizing Water Scam Resurfaces

Submitted by Ken McCarty
May 17, 2009

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Claims that ionizing water turns it into a “miracle liquid” with potent powers of disinfection are dubious.   One of the recent versions of this scam blatantly states that the substance cures athletes’ foot and yet it is safe to drink.  Fish and poultry industries use it without adversely affecting the quality of the food. This simple formula can be whipped up on the spot by any cleaning crew with the right ionizing equipment. This sounds like a great product for use in hospitals, sterile manufacturing and lab environments doesn’t it?

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Author: Daisy McCarty

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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