Industry Must Maintain Hard-Won Reputation in Medical Gases

By Thomas L. Badstubner

Every year, well over 30 million medical gas cylinders are safely filled in several thousand locations registered with the Food and Drug Administration (FDA) in the United States. Additionally, more than 250,000 trailer loads of medical oxygen are safely transported annually. After years of diligent work between the Compressed Gas Association and Gases and Welding Distributors Association membership, our industry has earned credibility with the FDA and has shown that we are capable of providing safe and reliable prescription drug products. The FDA has reported that because of our history and diligence, our industry now is subject to fewer FDA inspections than traditional pharmaceutical companies and any observations listed as a result of those inspections are certainly less frequent and less severe than traditional pharma.

This hard-earned credibility can only be sustained by continued vigilance, awareness and attention to detail by all medical gas providers at all times. A single failure or significant non-conformance issue can negatively affect the thousands of registered gas facilities, if the agency believes there is a systemic problem that impacts the industry. The well-being of our customers and the patients under their care are dependent on us to do the right things to ensure the safety of our products, and ultimately patient safety.

You can maintain good performance by assuring a robust medical gas program at your company and by following the applicable Current Good Manufacturing Practices (CGMP), industry guidance and best practices. As part of your company’s medical gas compliance program, consider the following high-profile compliance issues.

TAMPER-PROOF CONNECTIONS

The requirements for tamper-proof fittings on medical cryogenic containers published in CGA SB-26 has been formally codified into the regulations by the FDA. These tamper-proof fittings, along with adequate and appropriate training of employees and customers, can save lives by ensuring the correct product is filled into the container and ultimately administered to the patient.

Action steps:

  1. Ensure that each of your medical gas cryogenic containers are equipped with tamper-proof fittings in accordance with CGA SB-26.
  2. Ensure that your employees are adequately trained in the requirements of SB-26 and can recognize tamper-proof connections.
  3. Ensure your drivers are trained to never change, modify or adapt container fittings to connect to the customer medical system. (Contact tom@asteriskllc.com for free training materials).

CALIBRATION OF MEASURING DEVICES

One of the top reasons the FDA gives for requiring a medical gas recall is: “The pressure gauges, vacuum gauges, and thermometer had surpassed the calibration expiry period, which may have resulted in overfill/underfill of oxygen cylinders.”

Action steps:

  1. Ensure your gauges, thermometers and scales are calibrated in accordance with your written procedures (for example, annually).
  2. Develop and implement an internal system to remind when your equipment is due for calibration.
  3. Ensure equipment is labeled with a sticker to identify calibration due dates.
  4. Train employees to recognize out-of-calibration equipment and to report it to management.

PERSONNEL TRAINING

FDA inspectors scrutinize employee training records at most inspections, so it is critical that employees are adequately trained and records of the training are meticulously maintained. Training must be adequate for each specific job function for handling, filling, labeling, storing and distributing medical gas products.

Action Steps:

  1. Ensure all fillers, product testers, drivers and quality assurance reviewers are current with their annual CGMP training requirement.
  2. Develop and implement an internal system to remind when employee training is due.
  3. Randomly select several fill logs and label records for a secondary review for conformance. Provide coaching to employees if errors or omissions are discovered. Document the coaching as training. (Asterisk can provide an independent review of quality records by scanning or faxing records to Jodie@asteriskllc.com (or fax to 508-883-3558). Asterisk will provide feedback and make suggestions for improvements.)

PROCEDURES

Current written procedures must be available to all personnel involved with medical gas production and distribution. Procedures must be adequate and thorough for each job function. Personnel must be adequately trained and must follow the procedure as written.

Action steps:

  1. f your company subscribes to the GAWDA Medical Gas Standard Operating Procedure (SOP) Program, ensure that your compliance manual is current and up to date.
  2. Ensure your employees are adequately following the written SOP by performing “job observations.” This is accomplished by copying a procedure from the manual, (such as filling high-pressure cylinders) and then observing the employee as he or she performs the job steps. This is an excellent management training tool and is an opportunity to determine if changes to procedures are needed.

Contact tom@asteriskllc.com if you need resources to help you comply with the FDA regulations or to provide independent assurance that what you expect to happen is actually happening.