Could Selling Oxygen To Fire Departments Be Putting Your Company At Risk?

If fire departments, ambulance or other emergency medical responders are not following Current Good Manufacturing Practices, your company could be held liable if there is a problem with the cylinder.
By: Deanna Cohen
 
May 3, 2010 - PRLog -- Dewitt, NY – May 3, 2010: Any fire company, ambulance or emergency medical service (EMS) that fills medical oxygen cylinders is actually a “drug manufacturer.” This is true whether they cascade into “Medical E” style cylinders from “300” style cylinders or if they have a bulk tank, cryogenic pump and vaporizer.

The FDA has stated that these organizations are fully accountable for all CGMP regulations…except one. They are not required to register/list with the agency. Because they are not required to register/list with the FDA, they are almost never inspected. The FDA is exercising “enforcement discretion” with the EMSs. As a result, EMSs are typically not following Current Good Manufacturing Practices (CGMP).

In the current issue of Welding & Gases Today, the journal of the Gases and Welding Distributors Association (GAWDA), Thomas L. Badstubner, FDA & Medical Gases Consultant for the Gases and Welding Distributors Association (GAWDA), explains how to gauge your compliance exposure if you sell oxygen to fire companies or other emergency responders.  

Some EMSs will fill your “Medical E” style cylinders. The EMS is the drug manufacturer and they are responsible for assuring CGMPs. However, Badstubner warns, as the owner of the cylinder, you could be held liable if there is a problem with the cylinder. Bradstubner also points out that some EMSs fill the cylinders with your labels and lot numbers. While the EMSs are actually the ones in violation of the regulations, if there is an incident, you too could have significant exposure.

Read more of what Badstubner has to say in “What Is My FDA Compliance Exposure If Fire Departments Fill Medical Oxygen?” at Welding & Gases Today Online, the leading trade journal for the welding, welding equipment, industrial gases, medical gases and specialty gases industry.

For more information, contact Deanna Cohen, Editor of Welding & Gases Today, at editor@weldingandgasestoday.org or 315-445-2347.

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About GAWDA
Founded in 1945, the Gases and Welding Distributors Association (GAWDA) is the premier source for manufacturing knowledge, education and networking. Through its member journals (http://www.WeldingAndGasesToday.org), e-magazines, newsletters and industry wiki (http://www.gawdawiki.org), GAWDA connects suppliers of gases and manufacturers of related equipment as well as manufacturers of welding equipment and distribution leaders, for the purpose of safely delivering optimal solutions to the users of those products. GAWDA publications are the industry’s voice for all matters related to the latest technology and the most up-to-date processes spanning welding equipment and products and services related to industrial, medical, specialty and cryogenic gases. A 501(c)3 organization, GAWDA members are located throughout North America.
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Source:Deanna Cohen
Email:***@weldingandgasestoday.org Email Verified
Tags:Oxygen, Emergency Services, Gases & Welding
Industry:Business
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