Preventing Medical Gas Mix-Ups

Awareness and training are not a given.

By Mike Lopez

We all accept the fact that accidents happen everyday. Without some extraordinary circumstances or ironic twist, even fatal accidents barely make the local news. But when a patient dies at a healthcare facility from being administered the wrong drug, that's news. It always will be. It's news we can all live without.

Medical gas mix-ups are rare in our industry. When we consider why they occur, even the smallest number is unacceptable. Mix-up incidents aren't simply a matter of mistakenly preparing, delivering or administering the wrong gas. In order for a mix-up to occur, someone has to break a rule or defeat a safeguard. Oftentimes, mix-ups result from a combination of errors.

One of the best safeguards our industry has instituted was the assignment of a unique connection for oxygen that was adopted by the American Standards Association in 1949 and later, by the U.S. Department of Transportation. Strict adherence to this standard should prevent product mix-ups. Additionally, labeling, color coding, defined procedures and quality control are all considerations.

Responding to concerns about product mix-ups, the CGA and NWSA recently presented a program to the FDA wherein medical gas incidents were examined in light of the event and contributing factors, as opposed to merely considering the specific causes, and what action was needed to address potential contributing factors. The team of experts examined the supply process from the order pad to the bedside.

Labels
Process controls are necessary to ensure that labeling is consistent with the cylinders' contents. These include methods and equipment to make sure that the proper gas is filled into its intended cylinder, such as strict valve adaptor and label controls, adherence to color coding standards as secondary identification, documentation review and implementation of the CGA bulletin, SB-26, to safeguard against tampering with fittings after the cylinder has been filled.

Customers expect delivered product to be exactly what they ordered or intended to order. Acting on that expectation, maintenance workers could, and have, ignored labeling information and jury-rigged fittings to adapt incompatible connections.

Authorized Purchase
We must establish a clear communication with our customers to ensure that they are authorized to purchase drug products and can precisely identify the drugs they want. From this point, drivers thoroughly trained in techniques of product identification can expect to find the intended product in a clearly designated quarantine area and will know to check product labels prior to leaving and again when product is delivered. This will eliminate the possibility of delivering the wrong product, or grade of product, to the wrong customer.

Delivery
After product is delivered, who receives it? Where do customers put it and how do they control it? These and other questions about our customers lead to concerns beyond our immediate control.

Nevertheless, our expertise is important. First, customers must be aware of potential problem areas. The FDA has led the “awareness campaign” by introducing a poster and a flyer to warn against the dangers of valve outlet adaptors by encouraging customers not to accept cryogenic cylinders without appropriate labeling and anti-removal devices on valve outlets. (Both of these documents are available from the NWSA website for distributors to download and print.)

Trained Handler
Even though a facility may ensure that the proper gas is received, there is no assurance that trained and knowledgeable people will handle the cylinder. Unlike controls placed on virtually all other drug products, healthcare facilities typically place few controls on the aspects of cylinder handling that are critical to avoid mix-ups. Receipt, storage and distribution of medical gases within a facility are usually outside the responsibility of the pharmacy. Additionally, physical safeguards such as pin indexing and dedicated connections are rarely understood by those who actually connect cylinders to dispensing equipment.

Having identified these and other issues that increase the potential for product mix-ups, the industry is developing a plan to assist our healthcare customers in awareness, training, and specific recommendations. The FDA poster and discussion topics in the industry's presentation to the FDA should give distributors plenty of “starting tools” to help stop medical gas mix-ups permanently. Stay tuned for more - much more.