Conformity Magazine - September 2008 - (Page 63)

NewsBreaks continued from page 11 The list of standards for the directive was published in June in the Official Journal of the European Union, and replaces all previously published standards lists for the directive. Our readers can view the complete list at www.conformity.com/2117. (Note that the list runs more than 50 pages.) into account the physical characteristics of the environment in which medical devices are used. The report profiles several incidents reported to the FDA relating to human factors problems, including one case of a patient death directly related to noninvasive blood pressure tubing that was mistaken for an IV catheter tube. Our readers can view the complete FDA report on human factors at www.conformity.com/2119. through web retail sites, from November 2002 through December 2004 for between $130 and $150. Wireless Conference Phones: Polycom, Inc. of Pleasanton, CA has announced the recall of about 5800 units of its SoundStation 2W model wireless conference phones with lithium ion batteries manufactured in China. According to the company, the battery packs can overheat, posing a fire or burn hazard to consumers. Polycom says that it has received one report of a battery pack overheating, resulting in minor property damage, but no reports of injuries. The recalled conference phones were sold by authorized dealers nationwide from December 2007 through May 2008 for between $700 and $900. Glue Guns: Dollar Tree, Inc. of Chesapeake, VA has recalled about 470,000 Crafters Square brand hot melt mini glue guns manufactured in China. The company says that the recalled glue guns can short-circuit, causing the gun to smoke and posing a fire hazard to consumers. Dollar Tree has received four reports of the glue guns shortcircuiting, but no reports of injuries. The recalled glue guns were sold through Dollar Tree and Dollar Tree-affiliated stores nationwide from December 2007 through March 2008 for about $1. Utility Vehicles: Finally, MTD of Brownsville, TX is recalling about 700 units of its Cub Cadet 4x4 EFI Volunteer utility vehicles. MTD says that excessive heat can cause the wiring harness to melt, posing a fire hazard to consumers. The company has received five reports of heat damage to the vehicles, but no reports of injuries. The recalled vehicles were sold through Cub Cadet dealerships and Bass Pro retail outlets nationwide in March and April 2008 for between $9700 and $10,500. Our readers can learn more about these and other product recalls through the CPSC web site at www.cpsc.gov. Commission Publishes Updated Standards List for the EU’s Personal Protective Equipment Directive The Commission of the European Union (EU) has published an updated list of standards that can be used to demonstrate conformity with the essential requirements of it directive on personal protective equipment (89/686/ EEC). The list of standards for the directive was published in June in the Official Journal of the European Union, and replaces all previously published standards lists for the directive. The complete list can be viewed at www.conformity.com/2118. 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: Remote-Controlled Helicopter Toys: Westminster, Inc. of Atlanta, GA is recalling about 102,000 of its “Thunder Wolf” remote controlled indoor toy helicopters manufactured in China. Westminster says that the rechargeable battery inside the helicopter can overheat, resulting in the helicopter body melting and the risk of fires or burns to consumers. The company has received seven reports of overheating and/or melting of the helicopter, and two reports of minor property damage. The recalled toy helicopters were sold in retail stores nationwide from June through December 2007 for about $20. Fax Machines: The Hewlett-Packard Company of Palo Alto, CA has recalled about 367,000 units of its HP Fax 1010 and 1010xi machines manufactured in China. The company says that an internal electrical component failure can cause overheating of the machines, posing a risk of fire or burns. HewlettPackard has received three reports of overheating, including two reports of minor property damage, but no reports of injuries. The recalled fax machines were sold through electronic, computer and camera stores nationwide, as well as FDA Links “Human Factors” to Adverse Events with Medical Devices Medical devices with poorly designed user interfaces can be an important source of adverse events associated with their use, according to a recent report by the U.S. Food and Drug Administration (FDA). The report, entitled “How Human Factors Lead to Medical Device Adverse Events,” discusses good human factors design principles, and specifically addresses visual, auditory and tactile considerations that manufacturers should take into account when designing the medical device user interface. The report also includes design guidelines that take September 2008 Conformity 3 http://www.conformity.com/2117 http://www.conformity.com/2119 http://www.conformity.com/2118 http://www.cpsc.gov

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

Conformity Magazine - September 2008 Contents Editor’s Note Commission Adopts Regulations for Internet-Based TRS Services Another Company Fined for Non-Compliance with HAC Requirements FCC Extends “Do-Not-Call” Registry Compliance Requirements Marketing Company Gets $1.4 Million Fine for Junk Faxes EU Commission Codifies Directive on TTE Market Competition EU Commission Releases Updated Standards List for the R&TTE Directive Updated Standards List for the “New” Low Voltage Directive Released New Standards List Released for the EU’s Machinery Directive The ESD Association: Voluntary Standards in Action ESD Open Forum Medical EMC Standards: Towards the 4th Edition of IEC 60601-1-2 iNARTE Informer Pre-Pulse Voltage in the HBM ESD Model Digital Interfaces and EMC Performance ESD Design Buyer’s Guide Product News Commission Publishes Updated Standards List for the EU’s Personal Protective Equipment Directive FDA Links “Human Factors” to Adverse Events with Medical Devices CPSC Actions in the News IEC Standards Update UL Standards Update Product Reviews Telcordia Standards Update From Our “You Can’t Make This Stuff Up” Department Looking Back: Items from Past Issues of Conformity Advertisers

Conformity Magazine - September 2008

For optimal viewing of this digital publication, please enable JavaScript and then refresh the page. If you would like to try to load the digital publication without using Flash Player detection, please click here.