FDA Announces Program To Strengthen Medical Device Safety

The U.S. Food and Drug Administration (FDA) is launching a new program to strengthen the way it monitors the safety of medical devices. The announcement came after an internal FDA report criticized the agency for failing to effectively monitor medical devices after they are approved and on the market.

The report said the FDA’s Center for Devices and Radiological Health (CDRH) doesn’t get full information about problems that arise with medical devices and isn’t always able to properly analyze what data it does re-ceive. These problems have received increased attention recently with the well-publicized recalls of pacemakers and defibrillators manufactured by troubled medical device maker Guidant.

The new program is called the CDRH Postmarket Transformation Initiative. According to the FDA, the initiative will allow the agency to identify, analyze and act on problems more quickly, meaning the public can be alerted sooner about potential issues.

Areas the initiative will focus on include:

  • Developing an electronic reporting system for ad-verse medical device events.
  • Identifying medical devices using standardized and globally accepted names.
  • Improving device information in patient records.
  • Improving collaboration on postmarket safety within the FDA and with professional organizations and the medical device industry.

A team of senior level FDA management and outside consultants will head the project. The team is expected to have recommendations back to the CDRH by the end of May.

For more information, go to www.fda.gov/cdrh/postmarket/mdpi.html.


Large Capitalizations Affect Q-100 Comparison to S&P

For the quarter ending Dec. 31, 2005, the
Q-100 lagged its Standard & Poors (S&P) 500 benchmark, increasing 1.70% compared to a 2.09% gain for the S&P.

Once again, companies with very large market capitalizations had the greatest influence on the Q-100, masking the excellent performance of several small to mid-size companies.

In a reversal of last quarter, energy and utilities were among the weakest performing sectors, with the largest energy companies faring the worst. Noble Corp., one of the smallest companies in the Q-100, ranked fifth of 29 companies in the S&P 500 energy sector. Among the quarter’s top performing sectors, basic materials led the way, followed by financials and consumer discretionary.

Monsanto, NuCor, State Street Corp., Starbucks and Johnson Controls all ranked among the top 10 performers in their respective sectors. Other Q-100 companies turning in top 10 performances within their economic sectors included FedEx, Wal-Mart, PepsiCo and UnitedHealth Group—showing that big isn’t bad, just influential.

No companies were added to or removed from the Q-100 during the fourth quarter. However, announced changes to the S&P 500 combined with increasing mergers and acquisitions and another scheduled Q-100 rescoring cycle will almost certainly lead to changes in the first half of 2006.

The Q-100, developed by Craig Robinson and Mark Billeadeau, is a capitalization weighted index of leading quality oriented companies in the S&P 500. Robinson and Billeadeau, formerly with Robinson Capital Management, are now part of the total quality management team of Kopp Investment Advisors, Edina, MN.

Short Runs

THE BALDRIGE NATIONAL QUALITY PROGRAM is offering electronic self-assessment for organizations seeking improvement using the Malcolm Baldrige National Quality Award excellence criteria. Business, education and healthcare organizations that complete a profile will receive a report comparing their efforts with those of other organizations. The self-assessment tool can be found at www.quality.nist.gov/eBaldrige/Step_One.htm (case sensitive).

THE INTERNATIONAL SOCIETY FOR PERFORMANCE IMPROVEMENT has issued a request for proposals for its fall instructional systems conference Sept. 14-16 in Anaheim, CA. The conference will focus on determining when learning should occur and the best way to achieve it. Proposal deadline is April 3. For details, go to www.ispi.org/Fall2006/is/2006_ISconferenceProposalRequest.doc (case sensitive).

THE OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION has endorsed ISA’s (formerly the Instrument Society of America) three-part standards related to the prevention and mitigation of accidents involving hazardous chemicals. For details, go to www.isa.org.

THE AMERICAN NATIONAL STANDARDS INSTITUTE and ASTM International have adopted ISO/IEC, General Requirements for Bodies Operating Certification Systems of Persons, as an American national standard. The standard was developed with the participation of U.S. experts and published in 2003 by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC).

THE HEALTH AND HUMAN SERVICES DEPARTMENT has signed $6 million in contracts for a pilot project to test electronic prescribing standards. The pilot will focus on fundamental aspects of how medications are prescribed and how to reduce errors, time and costs. The standards may ultimately result in an e-prescription system for the new Medicare Part D prescription drug program. For more information, go to www.hhs.gov/news/press/2006pres/20060117a.html.

THE UTILIZATION REVIEW ACCREDITATION COMMISSION (URAC), the only U.S. organization that accredits health websites, is tightening the requirements to earn its seal of approval. The first update since the original accreditation standards were developed in 2001, the new standards require extra steps to increase security of users’ personal information. They also ensure site content is peer reviewed before it appears online and require the names of content team members and all editorial sources be posted. For more information, go to www.urac.org.

METROLOGY SOCIETY ISSUES CALL FOR PAPERS The Coordinate Metrology Systems Conference (CMSC) Society has announced a call for papers for this year’s CMSC, July 17-21, Orlando, FL. E-mail abstracts to presentations@cmsc.org by April 10. For more information about the conference, go to www.cmsc.org.


Quest for Excellence Conference April 24-26

The eight annual Quest for Excellence conference will be April 24-26 in Washington, DC.

The 2005 recipients of the Malcolm Baldrige National Quality Award will present workshops related to their performance practices, journeys to performance excellence and lessons learned.

Two preconference workshops on April 23 will address the needs of organizations with different levels of experience and exposure to the Baldrige National Quality Program and the Baldrige criteria. The workshops can be attended without registering for the conference.

The National Institute of Standards and Technology, ASQ and the American Society for Training and Development co-sponsor the event. For details on the conference, workshops and registration, go to www.quality.nist.gov/Quest_for_Excellence.htm (case sensitive).


AHRQ Releases National Healthcare Quality and Disparities Reports

Quality of healthcare for Americans has continued to improve modestly, and healthcare disparities are narrowing for many minority Americans, according to reports by the Department of Health and Human Services’ Agency for Healthcare Research and Quality (AHRQ).

The findings are in the 2005 National Healthcare Quality Report and 2005 National Healthcare Dis-parities Report. The annual reports measure quality and disparities in four areas of healthcare: effectiveness, patient safety, timeliness and patient centeredness.

The quality report uses measures such as hospital acquired infections and reductions in deaths from certain diseases. It also measures how well the healthcare system is using specific treatments known to work most effectively.

The 2005 quality report shows overall quality of care for Americans improved at a rate of 2.8%, the same increase shown in the 2004 report. However, the report notes much more rapid improvement in some measures, especially those in which there have been focused efforts to improve care.

The disparities report compares the measures by race, ethnicity and income and measures access to care using indicators such as health insurance status and frequency of visits to a physician. This year, for the first time, the report also shows trends in healthcare disparities from year to year.

The report shows many of the largest disparities in quality and access occur for low-income people regardless of race or ethnicity, though with some signs of improvement. Overall, more racial disparities in quality of care were narrowing than were widening, and most racial disparities in access were narrowing for blacks, Asians and American Indians/Alaska natives. For Hispanics, the majority of disparities for both quality and access were growing wider.

The AHRQ reports are available at www.qualitytools.ahrq.gov, by calling 800-358-9295 or by e-mailing ahrqpubs@ahrq.gov.

The FACE of Quality

Name: C. Jackson Grayson Jr.

Residence: Houston, TX.

Education: Doctorate in business from Harvard Business School.

Current job: Founder, chairman and CEO of the American Productivity and Quality Center, a nonprofit organization in Houston.

Previous jobs: Dean of the business schools at Tulane University (New Orleans) and Southern Methodist University (Dallas). Grayson has also worked as a newspaper reporter, a special agent of the FBI, a manager of a cotton farm and an owner and breeder of racehorses.

Introduction to quality: “I probably first noticed quality on my family farm,” Grayson says. His father always rotated crops—this was not only to increase yields but also because the elder Grayson thought the land needed to be systematically brought back to quality production levels through rotation.

ASQ honor: Recipient of a 2003 Distinguished Service Medal, the highest ASQ honor.

Other achievements: As a member of the White House Commission on Productivity in 1982, coordinated an effort that recommended a national award for quality. This became the Malcolm Baldrige National Quality Award in 1988.

Published works: If Only We Knew What We Know: The Transfer of Internal Knowledge and Best Practice with Carla O’Dell (Free Press, 1998); American Business: A Two Minute Warning (Free Press, 1988); Decisions Under Uncertainty: Drilling Decisions by Oil and Gas Operators (Ayer, 1982); Confessions of a Price Controller with Louis Neeb (Dow Jones-Irwin, 1974).

Personal: Married; four sons.

Favorite ways to relax: Reading, travel (he has visited all seven continents), work and movies; went skydiving for his 75th birthday.

Quality quote: When I first had the idea for a national quality award, I thought of it applying mostly to business. I am so pleased that it, the Baldrige award, now applies to almost every sector—business, healthcare, education—and one day, hopefully, to government. It applies to small and large firms, manufacturing and services. This shows the need for a quality focus is pervasive and universal and that quality applies to every individual, every sector, every nation.


Nurses More Likely Than Doctors To Report Medical Errors

According to a study by physicians at Tufts-New England Medical Center in Boston, nurses are much more likely than doctors to report medical errors.

The study examined 26 U.S. hospitals in which staff reported medical errors via computer. From January 2001 to September 2003, hospital staff reported 92,548 errors, less than 1.5% of which caused patients permanent injury or contributed to a death. Registered nurses made nearly half the reports, while doctors contributed less than 2%.

Pharmacists, technicians and secretaries reported the remainder.

For more information, go to www.nemc.org/home/news/pressrel/ 2006/06010901.htm.


Six Sigma Awards Program Launched

Worldwide Conventions and Business Systems (WCBF), a company that hosts Six Sigma conferences, has launched the Global Six Sigma Awards program.

The awards are open to all public and private organizations, and the deadline for entries is March 24. The program focuses on business results of Six Sigma—winners will be selected not on how they applied Six Sigma, but on the success they achieved.

Organizational awards will be given in eight categories: manufacturing, service and transactional environments, healthcare, financial services, government and defense, integrating lean and Six Sigma, design for Six Sigma, innovation through Six Sigma and Six Sigma in compliance.

One platinum award will be given to the most outstanding business achievement from all the categories. There are two individual awards—
CEO of the year and Six Sigma VP of the year.

The awards will be presented on June 28 during WCBF’s Global Six Sigma Summit at the Venetian Resort Hotel and Casino, Las Vegas.

Full guidelines and the entry form are available at www.tgssa.com.


Speakers Announced for World Conference

ASQ has released the list of speakers for 2006 World Conference on Quality and Improvement May 1-3 in Milwaukee.

Keynote speakers will be:

  • Sister Mary Jean Ryan, president and CEO, SSM Health Care, St. Louis. SSM was the first healthcare organization to win a Malcolm Baldrige National Quality Award.
  • James McCaslin, president and COO, Harley-Davidson Motor, Milwaukee. Formerly Harley-Davidson’s VP, continuous improvement, McCaslin is now responsible for design, supply, manufacture, marketing and sales.
  • John M. Jones, executive VP and COO, Green Bay Packers, Green Bay, WI. During his 10-year tenure with the National Football League (NFL) Management Council, Jones helped create the NFL collective bargaining agreement, the salary cap system and the electronic contract reporting system now used by every team to report player signings by e-mail.

Other speakers are:

  • David Kohler, group president, Kohler Co. Kitchen and Bath Group, Kohler, WI.
  • Paul E. Borawski, executive director and chief strategic officer, ASQ.
  • Lou Gentine, chairman and CEO, Sargento Foods, Plymouth, WI.
  • Cyndi Crother, author, speaker and organizational consultant.
  • Benjamin S. Griffin, commander, U.S. Army Material Command, Fort Belvoir, VA.
  • Bernard Amadei, professor of civil engineering, the University of Colorado at Boulder.
  • Cecilia Kimberlin, group VP of quality assurance and compliance, Abbott Laboratories’ Medical Products Group, Abbott Park, IL.

For more information, go to http://wcqi.asq.org/speakers/index.html.

ASQ News

WILLIAM HARRAL, 1942-2006 A former member of ASQ’s board of directors, William Harral, died Jan. 24. Harral joined ASQ in 1984, became a Senior Member in 1987 and was voted a Fellow in 1992. He was a member of the Automotive, Reliability and Audit divisions and a certified quality engineer, reliability engineer, quality auditor and quality manager. Harral, who was active in the Greater Detroit Section, received six Craig Awards from 1988-2001. The Craig Award is given by the ASQ Automotive Division for, “the best technical/management papers relating to quality and reliability, written by the Automotive Division members.”

SOCIAL RESPONSIBILITY TAG STILL SEEKING MEMBERS The first draft of the International Organization for Standardization standard on social responsibility is scheduled for circulation this month, but organizations interested in helping develop the standard still have time to contribute. The U.S. Technical Advisory Group (TAG) on social responsibility, which is developing the standard, is looking for additional members. Membership is open to all U.S. parties who are affected by the standard. For more information, contact ASQ’s standards team at standards@asq.org or visit www.asq.org/social-responsibility.

INTERNATIONAL CHAPTER TO MEET AT WORLD CONFERENCE Every year, ASQ’s international chapter holds a meeting at the World Conference on Quality and Improvement, open to all conference participants. This year’s meeting will be May 1 from 6 to 8:30 p.m. In previous years, quality professionals from more than 40 countries have attended.

ASQ OFFERS ONLINE NETWORKS ASQ offers several online networks, each focusing on a particular area of interest. To access the networks, go to www.asq.org/communities. Current networks focus on Baldrige for education, Baldrige for healthcare, community good works, the economic case for quality, the National Quality in Education Conference, quality supports and services for persons with disabilities, and Sarbanes-Oxley. Future networks are planned for innovation, insurance and environmental microbiology. All are open to members and nonmembers.

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