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Training Prevents Medical Gas Mix-ups- 6/6/2012
Since the tragedies of 1998 where two nursing home patients died from a medical gas mix-up, the Food and Drug Administration (FDA) has focused on effective training as a way to prevent future problems. GAWDA’s FDA & Medical Gases Consultant Thomas L. Badstubner details appropriate driver training for medical gases in his article “Medical Gas Training For Drivers.” The article appears in Welding & Gases Today, the leading magazine for the gases and welding equipment industry.
Badstubner recommends that drivers who are delivering medical gases be trained on the FDA’s Current Good Manufacturing Practices (cGMP). Furthermore, FDA recommends that cGMP training not be conducted in one massive training session. Rather, it should be presented in smaller, more manageable sessions held throughout the year, or at a minimum be held once a year.
In recent inspections, the FDA has renewed its enforcement commitment to cGMP training for drivers. Medical gas firms have received violations when the driver cGMP training records were not current. The FDA has even gone back into training records for prior years and found unfortunate gaps in training records.
An agenda for a Driver cGMP Training session should include information on medical gas connections; regulations; cGMP Subpart B – Quality Control Unit/Personnel Responsibilities; cGMP Subpart G – Packaging & Labeling Controls; cGMP Subpart H – Holding & Distribution; cGMP Subpart J – Records and Reports.
To learn more about what topics a driver needs to know, read “Medical Gas Training For Drivers” at Welding & Gases Today Online.