A Mother’s Pain
AAMI President Responds to Letter on Tubing Misconnections
This past week, AAMI President Mary Logan received an e-mail from an AAMI member who shared the heartbreaking news that her daughter and granddaughter died as a result of a tubing misconnection six years ago. The writer challenged AAMI and the medical device industry to move faster in addressing this problem, calling for tube redesigns “now.” Logan responded to the writer, detailing what AAMI is doing on this front. Here are excerpts from Logan’s letter.
I am so sorry for your loss. I'm a mom and a grandma, too, and I don't even want to let my mind go there because just thinking about the possibility is terrifying.
I joined AAMI in 2009 and this particular issue has moved and ignited me more than any other. In my role as CEO, I do not actively participate in standards development, but I follow this work closely and stay in touch with the committee co-chairs regularly because of the importance of this work being completed as soon as possible.
I know it seems very slow, but I hope you will believe me when I say that the 26 U.S. experts participating in the development of the new international design standards are, to a person, highly committed to solving the problem of tubing misconnections. A nurse on the FDA staff is the convener of both the domestic and international multidisciplinary groups. Standards development is rigorous. The experts who do this work want it to be done right the first time, because the wrong outcome will lead to a more dangerous healthcare environment than what currently exists. The worst thing that could happen would be for the new standards to result in unintended consequences that don't really solve the problem, that create new risks, etc.
Some have asked why the development of standards is necessary: Why can't the companies simply redesign their products without standards? They could and then we would have market and user chaos, because there would be no uniform way of addressing the issue. (Imagine the chaos if every electrical appliance in your home had a different type of plug requiring a different sized outlet.)
Healthcare organizations are complex systems, and that means new connectors cannot be designed in a vacuum, without taking into consideration the complete clinical environment. To add to the complexity, these connectors are used for multiple purposes: breathing systems, limb cuffs, neuraxial access, parenteral and vascular applications, enteral and gastric access, urethral and urinary access, etc. And there are at least nine disparate features of the connector that must be considered on top of all of these different applications (for example, the length of the male Luer, the inner diameter, the outer diameter of the Luer lock collar, etc.).
The most important standard has been approved in draft, and the new design will now be tested (a rigorous process in and of itself). Adjustments will be made to the draft standard, and the complexity of those adjustments will depend in part on the outcome of the testing. Then, industry will have to begin the process of converting to the new connectors, which they say will take a minimum of 18 months (re-tooling everything).
I will share your e-mail with the committee leaders, and I know they will push even harder because they, too, will feel your pain.
Posted: July 17, 2012