Conformity Magazine - March 2008 - (Page 6)

Editor’s Note If It’s Broken, Don’t Fix It In this month’s NewsBreak section, we report on an internal study released by the U.S. Food and Drug Administration (FDA) that paints a grave picture of the state of that federal agency, which serves as America’s front line against unsafe foods and drugs. The study, entitled FDA Science and Mission at Risk, was prepared at the request of FDA Commissioner Andrew von Eschenbach by a subcommittee of the FDA’s own Science Board (which presumably operates above political agendas that might otherwise cloud such an assessment). The study’s findings will send a chill down the spine of anyone who believes that our government is taking every possible step to ensure the safety of the American public. Among the study’s fifteen findings are the following shockers (taken right from the report’s Table of Contents): • The FDA does not have the capacity to ensure the safety of food for the nation; • The development of medical products based on “new science” cannot be adequately regulated by the FDA; • The FDA lacks the information science capability and information infrastructure to fulfill its regulatory mandate; • The FDA has substantial recruitment and retention challenges; • The FDA has experience decreasing resources in the face of increasing responsibilities. These findings would be scary enough if they were unique to the FDA. Unfortunately, as we’ve seen during the past year, the FDA isn’t the only federal agency whose greatly expanded mission has been severely compromised by lack of resources. As we’ve written previously in this column (see Conformity, October 2007), the U.S. Consumer Product Safety Commission (CPSC), which is responsible for overseeing the safety of an industry that annually sells more than $1.4 trillion worth of consumer goods, works with a budget of just $62 million and a staff of just over 400 employees! The flap over the FDA report is just gaining traction in Congress, where the chairs of several Congressional committees have formally asked the FDA’s Science Board to comment on whether the FDA budget proposal for fiscal year 2009 is adequate to address these deficiencies. But, as with last year’s furor over the CPSC in the wake of the massive recall of unsafe toys from China, we fear that the very real challenges facing the FDA will quickly fade from view, that is, until the next major food or drug safety issue grips the attention of the American public. And that’s not a matter of “if,” but “when.” Bill von Achen, Managing Editor bvonachen@conformity.com Conformity marCh 2008 MIL-STD-461F: An Update The article An Update on MIL-STD-461F, which was published in the January issue of Conformity, discussed the newest revision to this forty year-old standard. Here are a few more details regarding the revision that were not included in the original article. (The editors would like to thank Ken Javor, the author of the article, for providing this additional information.) Release Date and How to Acquire Standard The release date of the standard is 10 December 2007. Readers can download a copy of the standard: http://assist.daps.dla.mil/quicksearch/ and by typing MIL-STD-461F into the “Document ID” field. Conducted Susceptibility, Damped Sinusoidal Transients, CS116 The requirement is no longer applicable to an unpowered test sample. Radiated Emissions Electric Field, RE102 Since MIL-STD-462D, a measurement system integrity check has been required prior to making emissions measurements. A slight change has been made to the procedure of paragraph 5.17.3.4.c.3. This is the instruction for using a 10 pF series capacitor between signal source and antenna base rod receptacle. Use of commercial injection networks different from that shown in Figure RE102-8 are no longer allowed. Figure RE102-8 is new in this standard, showing how to inject using a 10 pF blocking capacitor. Radiated Susceptibility Magnetic Field, RS101 MIL-STD-462D and MIL-STD-461E both allowed susceptibility sweep speeds up to three times faster than specified in Table III of the standard. Under MIL-STD461F, RS101 testing must be performed per Table III sweep speeds, essentially tripling the amount of time for this test. Erratum In our December 2007 issue, we published a NewsBreak piece on a report released by the U.S. Consumer Product Safety Commission (CPSC) on flame detection systems that are linked wirelessly to smoke detection systems incorporated into kitchen appliances. Our NewsBreak piece erroneously concluded that such wireless links can increase the time to alarm, thereby putting consumers at greater risk. However, the CPSC report concludes “that incorporating a flame detection system in an appliance will cause a wireless smoke alarm to sound almost immediately,” and that “the reduction in alarm times due to the wireless smoke alarm and flame detection system should increase reaction times to fires of this nature and allow additional egress time for building occupants.” Our readers can view the completed text of the report at www.cpsc.gov/library/foia/foia07/os/wireless.pdf. In the meantime, we apologize for the misinterpretation the report’s findings. http://assist.daps.dla.mil/quicksearch/ http://www.cpsc.gov/library/foia/foia07/os/wireless.pdf

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

Conformity Magazine - March 2008 NewsBreaks Editor's Note Adelstein Renominated to the FCC Industry Canada Publishes FAQs On RF Fields FDA Gives Its Scientific Capabilities Poor Marks FDA Offers Guidance On its Product Review Process FDA Publishes Updates to List of Recognized Standards FDA Warns of Patient Risk From Electric Dental Handpieces Complying with the EMC Directive, Second Edition ESD Open Forum Emerging Issues in Standards - Korean "RoHS": Not Like RoHS at All The iNARTE Informer Challenges in Testing - Field-Induced Charged Device Model: What Really Happens Design Fundamentals - EMI Shielding Technologies for Consumer Electronics Equipment Focus On...Compliance Software Buyer's Guide Additional Standards Published for the EU's ATEX Directive Additional Standards for the EU's Medical Devices Directive Also Published China to Require Bar Codes to Enhance Product Safety CPSC Releases 2007 Self-Assessment CPSC Actions in 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 - March 2008

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