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The Medical Industry
Business Weekly
August 28, 2008

Other Headlines

Company warns hospitals about unvalidated FirstCall probe files.
UnitedHealth Group of Minneapolis extends imaging accreditation deadline to the fourth quarter of 2009.
CMS releases guide to improve access to navigating Medicare requirements for approving innovative technologies.
Group of organizations discussed radiation dose used in scans performed on children at recent gathering.
With today's technology and treatments, doctors can find and fix osteoporosis.

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More Industry Headlines

Sonora Medical Systems Warns of Illegal Software Modifications Company warns hospitals about unvalidated FirstCall probe files.

Imaging Accreditation Deadline Extended by UnitedHealth Group UnitedHealth Group of Minneapolis extends imaging accreditation deadline to the fourth quarter of 2009.

Medicare May Approve Advanced Technologies Faster CMS releases guide to improve access to navigating Medicare requirements for approving innovative technologies.

Alliance for Radiation Safety in Pediatric Imaging Held Pediatric CT Vendor Summit Group of organizations discussed radiation dose used in scans performed on children at recent gathering.

LAST CHANCE -- PHILIPS Duo Diagnost Remote R/F Room So get your bids in early this week...if you "snooze," you could "lose" out on a great deal on just the system you want!
For instance: A GE Contour .5 MRI Mobile -- DYONICS Intellijet Arthroscopic Video System -- VARIAN Ximatron EX-1 C-Series Simulator -- ELEKTA Leksell 4C Gamma Knife * Plus many more systems are inside!

Doctors Get Treatment Right the First Time With a Virtual Heart Doctors could soon be able to perform minimally invasive surgery on virtual versions of people's hearts to help ensure they make the best decisions for their patients before doing the procedure for real.

AMA Concerned: New ICD-10 Proposed Rule a Burden for Physicians Physicians' group worries about administrative burden of proposed reimbursement coding system.

FDA, EMEA Will Consider Additional Toxicity Tests in Reviewing Drug Safety New joint effort might result in better detection of cellular damage.

Abbott Laboratories Will Eliminate Approximately 1,000 Jobs Abbott Laboratories Inc. will eliminate about 1,000 jobs over the next four years as part of a plan to streamline operations and cut costs in its medical diagnostics business.

GE Healthcare and Hologic Talk About Fan Beam Technology OEM briefings on the latest bone densitometry innovations.

The Association for
the Advancement of
Medical Instrumentation
(AAMI).

New Guidance Document Focuses on Water Quality for Reprocessed Devices

by Barbara Kram, Editor
Arlington, VA- The Association for the Advancement of Medical Instrumentation (AAMI) has developed a first-of-its kind guidance document addressing water quality for the reprocessing of medical devices. Now in final review, TIR34 - Water for the Reprocessing of Medical Devices - addresses the determination of water quality needs for reprocessing medical devices at various stages. It also describes how to assess, generate, monitor, and maintain water to meet those requirements.

"TIR34 will be of value to infection control practitioners, central sterile personnel, and physical plant/maintenance professionals," says Steve Goldstine, PhD, a sterilization consultant and co-chair of AAMI/ST/WG 95 - Water quality for reprocessing medical devices, which is the working group responsible for developing TIR34. "Because there are so many different types of equipment available for sterilizing water, this document can be very helpful as an aid in making equipment-purchasing decisions."

While AAMI has published other technical documents on water quality in the past, TIR34 is the first to focus on water quality specifically for reprocessing medical devices. After discussing the issue of water for reprocessing devices, AAMI's sterilization committee decided the issue was critical enough to warrant the creation of a working group. The late Lee Fischbach of Minntech, who served for many years as a developer of AAMI standards for water for dialysis, created the initial drafts of the TIR.

AAMI Releases New Chemical Indicator Standards

Three new AAMI/American National Standards on the use of chemical indicators in steam sterilization applications are now available at AAMI's online Marketplace. A chemical indicator is used to demonstrate that desired sterilization conditions have been achieved when sterilizing a medical instrument or set of instruments.

ORDER INFORMATION

ANSI/AAMI/ISO 11140-3:2007
LIST PRICE: $95
MEMBER DISCOUNT PRICE: $50
ORDER CODE: 1114003 or 1114003-PDF

ANSI/AAMI/ISO 11140-4:2007
LIST PRICE: $90
MEMBER DISCOUNT PRICE: $45
ORDER CODE: 1114004 or 1114004-PDF

ANSI/AAMI/ISO 11140-5:2007
LIST PRICE: $95
MEMBER DISCOUNT PRICE: $50
ORDER CODE: 1114005 or 1114005-PDF

To order these documents, call (877) 249-8226 or visit http://marketplace.aami.org

The new standards - available in print or PDF formats - have been adopted in full from their international (ISO) counterparts. Each standard pertains to a specific aspect of the Bowie and Dick-type test, which is designed to indicate rapid and even penetration of steam into a sterilization test pack.

Further information:
ANSI/AAMI/ISO 11140-3:2007, Sterilization of health care products-Chemical indicators-Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test is identical to ISO 11140-3:2007.

ANSI/AAMI/ISO 11140-4:2007, Sterilization of health care products-Chemical indicators-Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration is identical to ISO 11140-4:2007.

ANSI/AAMI/ISO 11140-5:2007, Sterilization of health care products-Chemical indicators-Part 5: Class 2 indicators for Bowie and Dick-type air removal tests is identical to ISO 11140-5:2007.

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