From the desk of
Ed Sharpless, VP of Product Development
Email us with your comments:
Ed Sharpless, VP of Product Development, eds@williamlabs.com
February 2010
Redefining Transport & Storage Temperatures
Summary from "Ask the Standards Committee" at AABB 2009
To quote the Moderator, this was a “familiar topic.” At Session 9417-TC of the 2009 AABB, "Ask the Standards Committee," the Standards Committee leadership addressed recent changes in the 26th Edition Standards for Blood Banks and Transfusion Services, as well as questions submitted to the committee. more...
October 2009
Clarification Offered for Storage vs. Transport of Blood Components in Monitored Coolers
From October 2005 AABB Annual Meeting "Ask the FDA" Session
In response to several recent inquiries regarding the proper temperature for blood components during cooler storage or transportation, the association has re-released information from an "Ask the FDA" session at the October 2005 AABB Annual Meeting. more...
September 2009
Update: Storage vs. Transport of Blood Components
Some things just never change. Take, for example, this question from the "Ask the FDA" session at the October 2008 AABB Annual Meeting in Montreal. Today, another year later, we find our blood banking colleagues still challenged with defining the exact differences between transport and temporary storage. more...
In the News
Enfield, CT, February, 2010
William Labs Successfully Completes Annual Quality Audit
William Laboratories, Inc. (William Labs) successfully completed its annual quality audit for 2009. The audit, performed by a third party auditor, is conducted to assure that William Labs is maintaining its formal quality system. This is the company’s fifth consecutive year of a successful quality audit and CE certification.
The company’s CE certification meets the essential requirements of FDA 13485, a widely accepted international standard for medical devices, is the guiding document for the William Labs quality program and annual audit. ISO 13485 certifies that:
- an organization consistently demonstrates its ability to provide medical devices and related services that meet both customer expectations and regulatory requirements * there are controls in the work environment to ensure product safety
- risk management activities are implemented during product development
- specific requirements are set for the verification of corrective and preventive actions
William Labs designs and manufactures non-reversible temperature indicators that are used in the temporary storage and transport of blood products and other sensitive biologicals, under the product trade names Safe-T-Vue® and TRANS-VUE™.
“It’s a small, simple product but it plays an important role,” said Ed Sharpless, VP Development. “We take our product quality very seriously, and our successful audit means that our customers can be confident that our products perform as they should.”
For more information on William Laboratories:
www.williamlabs.com
Contact: Edward N. Sharpless, VP Development
Phone 800-767-7643, 860-749-1350
Fax 860-749-1351
Email: eds@williamlabs.com
