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FDA Grants Exclusive Interview with GAWDA
Last week, Duane Sylvia, consumer safety officer at the FDA Center for Drug Evaluation and Research, sat down with the editors of Welding & Gases Today, GAWDA's official member journal, to discuss the issues facing GAWDA members in this new year. At the top of the agenda were the new medical gases compliance guidelines. The review of the comments are well underway, though Sylvia was reluctant to give an official date for completion, acknowledging that his personal preference is to have the document out before the middle of the year. "Once the document has cleared all the requirements and is published in the Federal Register as a final ruling, it becomes the official guidance document," he said, "and inspections will begin almost immediately." Sylvia pointed to the challenge facing distributors in response to their need for compliance, coupled with their need to focus on cost. "The goal of the FDA is to make sure the consumer gets a safe and good quality drug. We focus on public health; while Medicare focuses on reduction of cost. Unfortunately, these two goals are mutually exclusive." And therein lies the dilemma for GAWDA distributors who are feeling the squeeze of reduced reimbursements along with higher prices. In an interview to be published in the next issue of Welding & Gases Today, Sylvia offers some suggestions to solve the dilemma. He also explains what makes a good quality control unit—from the FDA's perspective, how to avoid a 483, and what's on the horizon after the Medical Gas Guidelines are completed. He also details the top violations across the industry. Interestingly, Sylvia agrees that a multitude of regulations can hurt our industry, "because the industry is moving and still developing," and he is conscious of what they mean to GAWDA members, whom he calls among the best in the business. "After home-care companies, GAWDA distributors represent the second largest group in the industry. The third largest group is made up of the major manufacturers represented in the CGA." Sylvia acknowledged the hard work and efforts of GAWDA and our Medical Gas Consultants, Bob Yeoman and Ron Ball, to make sure our members are in compliance. He said, "Most GAWDA distributors are completely on board. A benefit of membership in GAWDA is having access to up-to-date information and consultation, and it's showing through."
Ivey Delivers First Time, Every Time Nothing beats partnering on a pivotal deal, and nowhere is partnering more important than when a distributor seeks to enter new territory, deliver new products, or offer new services. Ivey Industries of Springfield, MA, knew this well, so when a longtime customer wanted a more efficient gas delivery system, President Bob Iverson knew whom to call.
The customer, a manufacturer of flexible gas piping and tubing, was seeing an increased demand for its products. The company's gas delivery system—individual high pressure cylinders delivered daily and moved throughout the plant, an Argon/Hydrogen mixture for welding, and Helium for leak checking—had gotten it so far, but with increased production, flaws in the system were becoming apparent. Ivey Sales Representative Gary LaPlante collected input from workers at the plant. "We listened, and we looked," he says. The problem became clear: inadequate supply on site for changes in production, a labor-intensive process to move cylinders, and various leaks causing quality problems. Cylinder manifolds and cylinder cradles would lessen the problem, but not solve it. Ground storage tubes were the answer: no cylinder handling, ample storage, and minimized leaks. The current liquid Argon station, gas mixer and Helium system could remain. For Ivey Industries, though, this would be its first installation of ground storage tubes. Iverson says, "The anxiety of doing a project for the first time is the most difficult part. Will the equipment work? Will it be delivered on time? Will I look bad in front of my customer?" Iverson turned to FIBA Industries and Executive Vice President Joe Sandello. Sandello knew what was needed and presented Iverson with a number of options for the customer—ASME tubes, DOT tubes, new, used, rent, lease or own. Iverson purchased a reconditioned unit from FIBA, which he now rents to the customer, maximizing his company's long-term profit. FIBA delivered the seven-tube, 2,400 psig ASME ground storage receiver right on time. All features were as promised—with stacks and valves oriented correctly and at the right height—both for the application and to meet CGA S-1.3 code. After eliminating the labor-intensive cylinder delivery system, Ivey now has Hydrogen delivery to the customer performed via third-party arrangement with supplier BOC. The customer's cost on product decreased, and the hours of labor previously directed at changing cylinders is now being applied to manufacture more tubing products. GAWDA welcomes new Distributor Member Economy Welding and Industrial Supply of Pittsburgh, PA, and new Associate Member Drahtzug Stein Wire & Welding of New Bern, NC. INDUSTRY
BEAT Bush Manufacturing Report Delivered at Lincoln Electric (Cleveland, OH) • On January 16, U.S. Commerce Secretary Donald Evans released the long-awaited Bush Administration study on the state of American manufacturing and the competitive forces it faces. Evans delivered the report at the headquarters of GAWDA member Lincoln Electric, during a roundtable with Ohio manufacturing leaders. The study, "Manufacturing in America: A Comprehensive Strategy to Address the Challenges to U.S. Manufacturers," is the result of an initiative undertaken by Commerce Secretary Evans that involved 20 public roundtables, with input from over 200 industry participants, conducted over a 5-month period last year. Evans announced that Grant Aldonas, Under Secretary for the International Trade Administration, would serve in an interim capacity as point person for manufacturers until Congress passes the legislation to create and fund the position of Assistant Secretary of Manufacturing and Services. The report includes an extensive series of recommendations for changes in government policy to improve the competitiveness of domestic manufacturers. You can obtain
a copy of the full report by clicking
here. Industry Heavyweights Bolster Overseas Presence • Airgas Inc. and The Lincoln Electric Company both made moves to strengthen their ability to serve foreign markets. Lincoln Electric acquired controlling interests in three different welding businesses in China, while Airgas formed Airgas Sakhalin LLC, a Russian limited liability company, with Interramashservis (IMS), a Russian company based on Sakhalin Island in Eastern Siberia. Lincoln will own an 85% share in a new welding equipment facility in China, plus direct majority ownership in two existing welding consumables businesses. The equipment joint venture, which will begin production in the second half of 2004, will be part of an overall transaction combining the new welding machine factory in the Baoshan district of Shanghai; an existing Baoshan flux-cored wire facility, with a Lincoln stake of 60%; a 60% holding in Jinzhou Jin Tai Welding & Metal Company's central consumables sales company in Shanghai; and a 70% stake in Rai Tai, a stick electrode factory in northern China. Airgas Sakhalin
will enable Airgas goods and services to qualify under "Russian
content" requirements mandated by Production Sharing Agreements
(PSAs) between the Russian Federation and foreign oil and gas companies.
The PSAs require that 70% of all contractors' supplies and services
used in the Sakhalin oil fields meet certain minimum Russian content
criteria. Airgas Nor Pac, one of Airgas's regional companies, has
served the Sakhalin market since 1997 through independent Russian
distributor relationships from its operations in Seattle, WA, and
Anchorage, AK. Airgas Sakhalin will enhance Airgas's ability to
supply industrial gases, welding supplies and safety products to
the many development projects underway in the region. Airgas will
oversee the management of the new company. Mark Bradley,
general director of Airgas Sakhalin, says, "The combined oil
and gas development on Sakhalin Island represents the largest construction
project in the world and we are excited about ramping up our presence
on Sakhalin as major development enters a new and expanded phase."
Jackson Products Files Chapter 11 (O'Fallon, MO) • Jackson Products Inc. will restructure its long-term debt through a pre-packaged Chapter 11 filing made on January 12. The process is not expected to stall daily operations of the safety equipment manufacturer and likely will be completed in less than 60 days. 3M to Purchase Hornell (Maplewood, MN) • 3M Company agreed to acquire Swedish welding supply manufacturer Hornell for approximately $100 million, pending regulatory approval. The new unit will become part of 3M's Occupational Health and Environmental Safety Division. Wilson Joins Airgas (Radnor, PA) • Dwight T. Wilson was appointed senior vice president-human resources for Airgas. Wilson will lead Airgas's corporate HR team as well as serve as the functional leader of human resources strategies throughout its regional and operating companies. Wilson joins Airgas from DecisionOne Corporation, where he served as senior vice president of corporate resources since 2001. Matheson Tri-Gas Parent to Merge (Parsippany, NJ) • Nippon Sanso Corporation, the Japanese parent of Matheson Tri-Gas, will merge with Taiyo Toyo Sanso, also of Japan, effective October 1, 2004. The new company's English name will be Nissan Taiyo Corporation. Each company has an equal stake in the merger, which is subject to approval by shareholders and "relevant public authorities." Tuesday Biggest E-Mail Day • A recent "Delivery Trends Report" from EmailLabs, a provider of e-mail marketing-automation solutions, suggests that companies send the most e-mail on Tuesdays, slightly more than on Wednesdays and Thursdays. Industry followers say e-mail recipients tend to be more receptive to messages in the middle of the week because they often leave early on Fridays and are overwhelmed with work when they return on Mondays. One in Seven Web Links Doesn't Work • According to a recent study by Jupiter Research, a whopping one in seven home pages on the Web contains links that don't work. The study, "Managing Web Site Quality: Stanching Consumer Defection," tested over 22,000 links. At least 80% of Web sites have faults serious enough to cause users to lose faith in the site's reliability and leave the site. Reasons for the failures include broken links, server errors and links to nonexistent pages. Take a Student to Work Day • National Job Shadow Day is Monday, February 2. You can use this opportunity to spread industry awareness and inspire young minds to develop an interest in gases and welding. Go to www.jobshadow.org for more details. Webinar Education for Distributors to Increase • Last year, GAWDA initiated a successful series of six webinars designed to educate GAWDA members on specific topics. Now GAWDA is broadening the scope of webinar education topics to include all industry issues and will begin offering a series of ongoing semi-monthly webinars to provide education and information to GAWDA Distributor Members, presented by Associate Members. For further information, please contact GAWDA Technology Consultant Scott Ehrnschwender at scottea444@aol.com.
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The GAWDA Connection is distributed on the 8th and 23rd of each month to all GAWDA members as a membership service of GAWDA, the Gases and Welding Distributors Association, 1900 Arch Street, Philadelphia, PA, 19103. Neither GAWDA nor Data Key Communications, LLC, their officers, directors, members and staff are responsible for contents or opinions other than those concerning Association activities.
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