Medical Gas Cylinder Filling Requirements For EMS

We see a growing trend in the medical gases business for emergency medical services (EMS) to refill their own Oxygen USP cylinders. EMS groups include ambulance squads, fire departments, emergency responders and rescue squads. A common perception among these groups is that FDA exempts them from all cGMP requirements. This is not the case. While FDA Ãœrecognizes EMS groups have limited operations, the agency does not provide an exemption for these firms. FDA expects them to comply with the minimum cGMP requirements for medical gas manufacturing. Section 17 of the new (draft) FDA guidance document specifically refers to EMS requirements.

The first and most basic compliance requirement for EMS groups is to establish a Quality Control Unit (QCU). It is acceptable for them to designate a single individual to fulfill this function at locations that only transfill small oxygen cylinders for their own use. EMS QCU personnel must have documented training in both general cGMP requirements and Quality Control procedures.

EMS groups next need to develop and implement an appropriate set of Standard Operating Procedures (SOPs) that detail the steps for filling medical cylinders in accordance with FDA requirements. SOPs should cover steps such as pre-fill inspections, cylinder evacuation, cylinder filling, quarantine and segregation procedures, analytical procedures, record keeping processes, and QCU operations, including product release procedures.

Documented employee training in basic cGMP requirements and the specific SOPs involved in filling medical gas cylinders is another minimum requirement for EMS groups. FDA requires that all employees involved in medical gas manufacturing operations, at a minimum, receive initial training and regular (annual) refresher training, and this requirement applies to EMS groups.

EMS groups must have effective control of their cylinder labeling process. These firms must ensure that a single readable label, which includes all applicable FDA and DOT requirements, is applied to each cylinder. The label needs to identify the firm that filled the cylinder, not who owns the asset. EMS groups must also apply lot numbers to provide traceability of filled cylinders. Label control requirements also extend to quarantine and release of new batches of labels, storage of labels and reconciliation of applied labels.

Record keeping is a key FDA requirement, and EMS firms need to maintain fill (pumper) logs for cylinder filling activities. These records must document production steps such as pre-fill inspections, label applications, filling, analytical results and QCU release.

Based on input from GAWDA members, it appears to be a common practice among EMS groups to top fill high-pressure cylinders, and that many EMS groups do not analyze filled cylinders. This highlights two more common misconceptions among EMS groups: They do not have to test filled cylinders, and they do not have to evacuate cylinders before filling. EMS groups must comply with the same requirements for analytical testing of high pressure medical cylinders that welding and gases firms are required to meet. FDA does not provide an analytical testing exemption for EMS high pressure cylinder filling.

The new FDA guidance document establishes an expectation that all medical gas cylinders will be blown down and evacuated prior to re-filling. Not evacuating cylinders and filling manifolds prior to refilling operations is a common way medical gases in cylinders become adulterated. Firms that do not blow down and evacuate, and do not analyze filled cylinders, are likely to eventually end up containing gases that do not meet USP requirements.

Partners In Compliance
Recognizing that few EMS groups have access to effective FDA compliance support services, GAWDA is introducing a new member service, the Partners in Compliance Program. EMS customers of GAWDA members can now access the same industry-sponsored compliance programs and support services offered to members for managing FDA compliance. The association offers these services through the member company, which allows GAWDA members the opportunity to provide a new compliance support service to their customers. The Partners in Compliance Program is also available to Home Health Care customers of GAWDA members.

Gases and Welding Distributors Association
Meet the Author
GAWDA Medical Gases Consultant J. Robert Yeoman is managing director of B&R Compliance Associates LLC in Lehigh Valley, Pennsylvania. Members can reach him at 610-837-6782 and at