Showing posts with label udi. Show all posts
Showing posts with label udi. Show all posts

Tuesday, August 11, 2015

Describing change management

Original post:  Feb 9, 2015

The UDI Program does hold powerful promise for the future. Unfortunately, many of our most important customers underestimate the incredible amount of change management that will be required in order to implement the program correctly. They also seem to have no idea how difficult it will be to transform the data generated by UDI into meaningful improvements in patient safety.

One way to help people understand is to relate these struggles to terms that they might have experienced in their own lives. In a discussion earlier today preparing for an upcoming panel presentation on UDI, I stumbled onto something that might be helpful.

There have been many changes to surgical procedures over the years. Each one of them started out as a new, unproven procedure. Someone had to invent the procedure. They had to try it out on a patient. When it worked, they had to document the procedure. They then had to show it to others. Once other surgeons agreed that it was an improvement over the status quo, they had to learn how to do the procedure in the same way and practice on their own. Over time, the repitition would eventually become the new practice.

We are in the earliest stages of UDI adoption. We still don't know all of the ways it can eventually improve healthcare. We've got to slowly build up our portfolio and then train others with a similar approach.

What do you think?

Monday, June 8, 2015

Sharp differences sharpen thinking

Original post:  Oct 16, 2012

In the past month, I've participated in a number of discussions with individuals representing organizations across the healthcare supply chain. Needless to say, we don't always agree.

One example occurred in the most recent GS1 US workgroup meeting. We were attempting to compile our comments for a submission to the FDA on the proposed UDI rule. GS1 US represents both hospitals and manufacturers at the same time. The hospital groups asked for a comment to reduce the time allotted for the implementation of the rule. On the other side, manufacturers were asking for more time because of the complexity of the rule. Both sides passionately believed that they were right.

On the one hand, there is a need for the data. It is difficult to overstate how hard it is to track individual items without a standardized method to account for them in the stream. On the other hand, the hospitals have no idea how difficult it is to gather information, verify its accuracy, and then to report on that information to the FDA while constantly under the threat of an audit that could literally shut down your business.

At the end of the session, we all agreed that it would be counterproductive to submit a comment that contradicted itself. Since we could not agree on the comment, each side was asked to work within their own organizations to submit that particular comment on that aspect of the rule.

While we didn't come to consensus, the episode did highlight the depth of passion on both sides. It also helped us understand that this vital process will not be implemented easily.

I find that I enjoy discussing these types of issues in depth with others. Debating the issue with others who challenge our thinking really helps to strengthen our own arguments in support of our ideas.