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FDA Clears Baxter's Modified Infusion Pump
The U.S. Food and Drug Administration (FDA) has cleared for
marketing a modified Colleague Volumetric Infusion Pump which
addresses many of the problems that prompted a series of Class I
recalls and a product seizure in 2005.
Confusing display screens, software defects, swollen batteries
and other defects could have resulted in the pumps either shutting
down or under- or over-delivering critical medication and fluids to
patients and were associated with serious injuries and deaths.
In June 2006, the manufacturer, Baxter Healthcare Corporation
signed a consent decree with FDA detailing the steps that must be
taken before the Colleague pump would meet appropriate regulatory
requirements and could be sold again. The agreement resolved a court
action by FDA that began with the October 2005 product seizure.
Readers can view the rest of the article at
this link.
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U.S., EU Renew Energy Star Program
The U.S. Environmental Protection Agency (EPA) and the Council of the
European Union (EU) have ratified the renewal of their agreement on
the energy efficiency of electronic products using the Energy Star
label.
As we previously reported (see Conformity, January 2007), the EPA
had issued new specifications for manufacturers of computers and
related equipment that wish to receive the Energy Star rating for
their products. The new Version 4 of the Energy Star specifications
is scheduled to become effective on July 20, 2007, but also required
adoption by the EU.
Our readers can view the test of the EPA press release announcing
the renewal of the U.S/EU Energy Star agreement at this
link.
The complete text of the notice regarding the agreement as
published in the Official Journal of the European Union can be viewed
at this
link.
The EPA says that it will be providing instructions to
manufacturers who currently participate in the Energy Star program on
how to continue their participation under the new specifications. In
the meantime, additional documents related to the development of the
Version 4 specifications can be viewed at this
link.
The above article was reprinted with permission from Conformity Magazine
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Did you know? |
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"70 to 90% of new designs fail first-time EMC testing, translating into high late-stage redesign costs and often even higher lost sales costs if the manufacturer delays the product-shipping date."
Source:
'Designing for EMC Early' by Fred German, Ph.D. FLO/EMC Product
Manager, Flomerics Inc.
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What is a..... |
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EMC/EMI Development Engineer?
Provides expert EMC/EMI (Electromagnetic
Compatibility/Interference) design guidance and evaluation to project
development teams and circuit board design engineers while optimizing
product/program designs to achieve global EMC/EMI regulatory
compliance
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684 W. Maude Avenue
Sunnyvale, California 94085
www.elliottlabs.com
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