Conformity Magazine - October 2008 - (Page 76)

NewsBreaks continued from page 11 for the directive. Our readers can view the complete list of standards for the directive at www.conformity.com/2216. Updated Standards List for EU Directive on Active Implantable Medical Devices The EU Commission has also published an updated list of standards that can be used to demonstrate conformity with the essential requirements of its Directive 90/38/EEC, relating to active implantable medical devices. The list of CEN standards, which was also published in July in the Official Journal, replaces all previously published standards lists for the directive, and can be viewed at www.conformity.com/ 2217. Finally, the Commission has published an updated list of standards that can be used to demonstrate conformity with the essential requirements of its Directive 98/79/EC, dealing with in vitro diagnostic medical devices. The list of CEN standards was published in July in the Official Journal, and replaces all previously published standards lists for the directive. The list can be viewed at www.conformity.com/2218. In a Public Health Notification issued in July, the FDA reported that a number of adverse events were likely to have been caused by high x-ray dose rates generated by some CT scanning equipment. The adverse events have included transient changes in pacemaker output pulse rates, malfunctioning of insulin infusion pumps, and unintended shocks from neurostimulators. The Notification advises healthcare professionals to take certain precautions during CT scan procedures, including moving external devices out of scan range or shutting them off all together, using the lowest possible x-ray exposure necessary to obtain the required image quality, and being prepared to take emergency measures if and when adverse reactions occur. Our readers can view the complete text of the FDA’s Public Health Notification regarding CT scans at www.conformity.com/2219. Guidance documents are intended to provide manufacturers with the agency’s current thinking on specific topics. However, guidance documents are not legally binding on the FDA, and are not a substitute for existing FDA regulations. Our readers can view the complete text of the agency’s latest guidance document at www.conformity.com/ 2220. CPSC Releases Import Safety Strategy The U.S. Consumer Product Safety Commission (CPSC) has released a report outlining the agency’s strategy for dealing with safety issues posed by imported consumer products. The report, entitled Import Safety Strategy, describes and discusses the CPSC’s four-pronged strategy for ensuring the safety of product reaching consumers, covering product design and pre-manufacturer, manufacturer, distribution and consumption. The strategy is reportedly an outgrowth of the Interagency Working Group on Import Safety, and is subject to future revisions as the CPSC implements specific initiatives. Our readers can view the CPSC’s Import Safety Strategy report at www.conformity.com/2221. FDA Provides Report Card on Its PMA Review Process The U.S. Food and Drug Administration (FDA) has released a revised guidance document that details the results of the agency’s efforts to improve the processing of premarket approval applications (PMAs) over the past five years. Under the Medical Device User Fee and Modernization Act (MDUFMA) of 2002, the U.S. Congress established aggressive performance goals for FDA action in connection with the processing of PMAs. The revised guidance document details the agency’s actual performance in this area for the period from 2003 through 2007, as well as new performance goals through 2012 as mandated under Congress’ reauthorization of the MDUFMA in October 2007. FDA Warns of Effects from CT Scans on Electronic Medical Devices The U.S. Food and Drug Administration (FDA) is warning healthcare professionals of a possibly harmful interaction between x-rays used in CT scans and both implanted and external electronic medical devices. 7 Conformity oCtober 2008 Other CPSC Actions in the News In conjunction with the U.S. Consumer Product Safety Commission (CPSC), the following manufacturers have issued voluntary recalls for certain consumer electrical and electronic products. Here are the details: http://www.conformity.com/2216 http://www.conformity.com/2220 http://www.conformity.com/2220 http://www.conformity.com/2219 http://www.conformity.com/2217 http://www.conformity.com/2217 http://www.conformity.com/2218 http://www.conformity.com/2221

Table of Contents Feed for the Digital Edition of Conformity Magazine - October 2008

Conformity Magazine - October 2008 Contents Editor's Note FCC Releases Annual Report on National Do-Not-Call Registry Commission Cracks Down (for the Fourth Time!) On Junk Fax Marketer FCC Releases Quarterly Reports on Consumer Inquiries and Complaints Greenpeace Ranks Electronics Manufacturers Standards List For The EU’s Energy Consumption Directive Published EU Commission Publishes Standards List for Directives on Pressure Equipment, Pressure Vessels Standards List for the EU’s Medical Devices Directive Available The IEEE Product Safety Engineering Society: The First Five Years ESD Open Forum Improving Election Security and Accuracy: The Future of Voting System Certification Conformity Assessment and Accreditation: Their Role in the Global Market Design Issues in Extreme EMC Environment Focus On... Test Equipment Buyers Guide Product News Updated Standards List for EU Directive on Active Implantable Medical Devices FDA Warns of Effects from CT Scans on Electronic Medical Devices FDA Provides Report Card on Its PMA Review Process CPSC Releases Import Safety Strategy Other CPSC Actions in the News IEC Standards Update Product Reviews UL Standards Update Telcordia Standards Update From Our “You Can’t Make This Stuff Up” Department Looking Back: Items from Past Issues of Conformity Advertisers

Conformity Magazine - October 2008

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