FDA audit response: bonding

Bonding a tip to the shaft of a catheter is a craft. To get it right, you must understand several things – such as the materials that the shaft and the tip are made of and the machine and tools that bond the two together.

The bonding department at Park 48 has 105 production employees who use about 50 bonding machines for their work. This team works on angiographic catheters, drainage catheters, and introducers. (Maybe your SBU sells a few of those?)

Bonding machine operators always cut open the first few products they build each day to carefully check the quality of the bond between the catheter (the blue part) and the tip (the black part).

To work in bonding, you must carefully monitor the variables, including time and temperature, that are required to create the best bond. You must also have a keen, sharp eye for product imperfections and what a good bond looks like. And it’s not always easy, because each bonding machine and set of materials has its own settings, imperfections, and quirks. A performance range is defined for each machine, but for decades it has been the operator’s knowledge, experience, and craftsmanship that has made the difference.

So, how big of a difference do they make? Between January 2011 and August 2014, nearly eight million of these products were sold. Only four of those products had problems in the field that were possibly related to the process (but more likely these were associated with the method of use). I think that those patients are probably grateful for how well the people in bonding do their jobs.

I’ve learned a lot about bonding over the last two months. When the FDA audited Cook, they asked us to do a better job of validating the processes we use in bonding. I’m part of an engineering team that works every day with this production department to complete those validations. They are working a lot of extra hours to meet our December 31 deadline, while still handling their normal workload. And did I mention, they have to put up with more engineers invading their workspace?

We caught up with a couple members of the bonding team to hear their thoughts about their work and how things are changing through the validation process. Listen to the audio recording below.

BEHIND THE BONDING MACHINES:

On behalf of everyone in engineering, I just wanted to say thank you to the team in bonding for their patience, help, and commitment to quality. I’m glad to work beside you.