How Bad Labelling Almost Killed Frank Stark

Frank Stark was dying of cancer. He developed a systemic staph infection, and after a week in hospital, he was sent home with an IV pump for six weeks of antibiotic therapy. What he and his wife, Nancy, got was an experience that almost cost Frank his life.

Nancy shared her experience with MMDI's Heather Thompson, who wrote:

Stephanie Wiseman

The first night, the pump beeped loudly and incessantly. They called the support hotline for the pump and got an answering service. After 15 minutes (the alarm did not stop), a representative from the company returned their call and said the batteries needed to be changed. The lock on the battery door was jammed, and Nancy, who has arthritis, could not open it. She had to use a hammer and screwdriver to jimmy the door.

Several times over the next few days, the pump displayed the error message "down occlusion." Nancy never saw the instructions for use (there was a photocopy of a photocopy of the instructions in a binder she found later, tucked under several pages of billing and product information) and had no idea what "down occlusion" meant. Again, she called the toll-free number and awaited a call back. The representative explained that there was a kink somewhere between the pump and the bag. Nancy never found a kink, but she removed tubing from the pump, massaged it, and reinserted it. The problem continued to occur at least once per day, so Nancy continued with the make-do technique.

The disturbances were enough that on Easter, when the couple attended evening mass, Frank shut off the pump and forgot to turn it back on. Nancy didn't realize the pump was off until noon the next day, and by then Frank was compromised. Nancy called an ambulance to take him to the emergency room. The event nearly cost him his life and resulted in a weeklong stay in the hospital, followed by hospice care...

"I would trade the first year of our marriage to get the extra two weeks I could have had without the faulty pump," Nancy says.

It should be noted that Nancy owns her own medical device consulting company and has 30 years of experience in the industry as a clinical research and biological safety testing expert. Frank was a mechanical engineer. Between the two of them, they should have been able to figure out how this device was supposed to work.

But a home user should never have to rely on his or her own education or ingenuity to figure out a device designed for home use.

So many things went wrong here. How can we avoid such debacles in poorly packaged instructions and labelling? And how do we better account for factors out of our control, like the environment, the user, and post-market considerations like repackaging and distribution?

How can the designer and engineer exercise effective risk control?

Stay relevant as a medical device packaging engineer

Stephanie Wiseman, Community Editor, UBM

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