Medical Gas Training For Drivers

FDA has renewed enforcement of cGMP training

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. In the 2003 Draft Guidance for Industry, Current Good Manufacturing Practice for Medical Gases, the FDA has issued specific instructions about driver training for medical gases:

The Agency recommends that each manufacturer establish and follow written training procedures for all truck drivers specific to their function, including Current Good Manufacturing Practice (cGMP) training. Truck drivers responsible for delivery of medical gases should be trained to examine the drug label and distinguish between medical gases and industrial gases, prior to unloading a container.

We recommend that all manufacturers who allow their drivers to connect large cryogenic containers to customer gas supply systems train their drivers in the specifics of those supply systems. We recommend cargo tanker drivers who fill medical gases into storage tanks also be trained.


This training is in addition to the mandatory Department of Transportation hazmat and function-specific training. In other areas of the Draft Guidance, the FDA has explained the training frequency:

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.

Following is an agenda for a Driver cGMP Training session.

Medical Gas Connections

  • Adaptors should never be used and fittings never changed on medical gas containers.
  • If a connection doesn’t fit, it isn’t supposed to fit. Do NOT connect it. Contact your supervisor.
  • Medical gases should be stored separately from industrial grade products in well-defined areas.
  • Know how to recognize a medical gas label (“USP” or “NF” will be on the label.)
  • Examine all labels carefully before hooking containers to the system.
  • Always check the container, labels and connections prior to introducing gas into a medical gas system.
  • Patients have been injured—and some have died—because of medical gas mix-ups. This usually occurs when the wrong gas is forcibly connected to the oxygen supply system. Never help a customer remove a container fitting or connect an incorrect container to their system.

Regulations

  • Gases for medical use are prescription drugs that must be carefully handled.
  • Gases are regulated by the Federal Food Drug and Cosmetics Act and 21 CFR Parts 210 and 211 and other regulations.
  • The Compressed Gas Association has publications to define medical gas practices (cylinder color, label wording, connection size/shapes, etc.).

cGMP Subpart B – Quality Control Unit/Personnel Responsibilities

  • Quality Control Unit (QCU) is responsible for the medical gas procedures and specifications.
  • QCU reviews and approves/rejects all medical gases. Never ship product until it has been released by the QCU.
  • All personnel handling drugs (medical gases) must be qualified and trained.
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.

cGMP Subpart G – Packaging & Labeling Controls

  • Medical gas and industrial gas segregation
  • Recognize medical gas labels.
  • Use the label as the primary identifier for medical gases.
  • Cylinders are also painted according to CGA guidelines (e.g. oxygen is green in the US).
  • Cylinders and containers must be labeled with their contents in liters, cubit feet, etc.
  • Lot numbers are required on medical gases.
  • Large medical gas cryogenic containers must have “tamper-proof” fittings. (Industrial large cryogenic containers should have “tamper-evident” fittings.)
  • Large medical gas cryogenic containers must also have a 360-degree wrap-around label identifying the gas as medical.
  • Adapters are not to be used to connect a medical gas container/delivery vessel to a customer unit.

cGMP Subpart H – Holding & Distribution

  • Lot numbers are recorded for each shipment.

cGMP Subpart J – Records and Reports

  • Any verbal or written customer complaint about medical gases must be reported immediately to the QCU.

Conclusion
We recommend that drivers who are delivering medical gases be trained on the FDA’s Current Good Manufacturing Practices.


Gases and Welding Distributors Association
Thomas Badstubner GAWDA’s FDA & Medical Gases Consultant Thomas L. Badstubner is president of AsteRisk LLC in Blackstone, Massachusetts. Members can reach him at 508-883-0927 and tom@asteriskllc.com.