Regulatory Update: Expired Medical Gas Cylinders (Connected to Medical Equipment)

This graphic (pictured right) represents a scenario that may be encountered in healthcare facilities. Specifically, the connection of medical gas cylinders to anesthesia machines and ventilators. A surveyor may encounter these configurations with past due product expiration dates affixed to or written on these cylinders.
 
Providing expiration dates for medical gas on cylinders is not an FDA requirement.  However, if they are present their placement is an indication that manufacturers have conducted a study to support the need for the label. When a Life Safety Code Surveyor (LSCS) sees a label the position to take is that a stability study was conducted for the product and the expiration date is valid.
 
Surveyors who observe medical gas cylinders in use with past due expiration dates will consider the deficiency and score at EC 02.05.09 EP 14. As a reminder, CMS COP K 926 Gas Equipment – Qualifications and Training of Personnel is enforceable.  Outlined below is a deep dive on the regulation language.

HCFC 11.5.2.1 Qualification and Training of Personnel

11.5.2.1.1* – Personnel concerned with the application and maintenance of medical gases and others who handle medical gases and the cylinders that contain the medical gases shall be trained on the risks associated with their handling and use.

A.11.5.2.1.1 –“Personnel” typically includes physicians, nurses, nursing assistants, respiratory therapists, engineers, technicians, and others.

11.5.2.1 .2 – Health care facilities shall provide programs of continuing education for their personnel.

11.5.2.1.3 – Continuing education programs shall include periodic review of safety guidelines and usage requirements for medical gases and their cylinders.

11.5.2.1.4 – Equipment shall be serviced only by personnel trained in the maintenance and operation of the equipment.

11.5.2.1.5 – If a bulk cryogenic system is present, the supplier shall provide annual training on its operation.

11.6 Operation and Management of Cylinders

11.6.1.2 – Training procedures shall include the following:

1. Maintenance programs in accordance with the manufacturer’s recommendations for the piped gas system,
2. Use and transport of equipment and the proper handling of cylinders, containers, hand trucks, supports, and valve protection caps, and
3. Verification of gas content and mechanical connection specificity of each cylinder or container prior to placing it into service.

5.1.14.2 Maintenance of Medical Gas, Vacuum, WAGD, and Medical Support Gas Systems

5.1.14.2.2.1 Inventories – Inventories of medical gas, vacuum, WAGD, and medical support gas systems shall include at least all source subsystems, control valves, alarms, manufactured assemblies containing patient gases, and outlets.

5.1.14.2.2.2* Inspection Schedules – Scheduled inspections for equipment and procedures shall be established through the risk assessment of the facility and developed with consideration of the original equipment manufacturer recommendations and other recommendations as required by the authority having jurisdiction.

A.5.1.14.2.2.2 – In addition to the minimum inspection and testing in 5.1.14, facilities should consider annually inspecting equipment and procedures and correcting any deficiencies.

5.1.14.2.2.3 Inspection Procedures – The facility shall be permitted to use any inspection procedure(s) or testing methods established through its own risk assessment.

5.1.14.2.2.4 Maintenance Schedules – Scheduled maintenance for equipment and procedures shall be established through the risk assessment of the facility and developed with consideration of the original equipment manufacturer recommendations and other recommendations as required by the authority having jurisdiction.

5.1.14.2.2.5 Qualifications – Persons maintaining these systems shall be qualified to perform these operations. Appropriate qualifications shall be demonstrated by any of the following:

1. Training and certification through the health care facility by which such persons are employed to work with specific equipment as installed in that facility;
2. Credentialing to the requirements of ASSE 6040, Professional Qualification Standard for Medical Gas Maintenance Personnel; or
3. Credentialing to the requirements of ASSE 6030, Professional Qualification Standard for Medical Gas Systems Verifiers.