>> I'm going to ask everybody to find their seats please.
If everyone can find their seat.
We're good at stretching here and we're also really good and listening.
So we know our teams appreciate that.
As everyone is I can maaing their way back to their seats, I will take this time to introduce
our next team, next team comes from the FDA.
This groups is led by Heather BALDIS.
Focused on creating a system to verify medical device unique identifiers in the field.
The team title is unique device identifier app.
Welcome, Heather.
[Applause] So let me tell you about us named Heather.
Our team is (indiscernible) and (inaudible) could not be here today.
Just as your car has a unique VIN number and notify you when recalls occur, UDIs can be
used to track medical devices.
As UDI from medical device label is shown here, this is used to uniquely identify that
device.
So most of us here work in public health in some way.
And all of us are also patients at some point in our lives.
As a patient if needed would you want to identify medical devices used to treat you or you carry
in your body?
So let's take one example.
What if you or someone you care about is one of 7 million American whose have a hip or
knee replacement?
One found there are as many as 260 recalls per year when they get to just hip and knee
device components.
Would you like to know whether you have one of those recalled components in your body?
One of our UDI team members is Terry Reed.
This is a photo of her mother who has three implanted devices.
And this inimplant she received after surgeryies the manufacturers name and model number for
her devices.
So let's search in UDI database on public website called access get ID for one of these
devices and if we search using information that was only the information on the implant
card, these are search results.
So with the manufacturer name and model number and no UDI, we can narrow down to one of these
three.
So without a unique device identifier we don't know what device Terry's mother has, UDI is
the only number that can uniquely identify a medical device.
Our projects focus on developing the app, users scan UDI on -- to verify accuracy of
the UDI and other device data.
Our vision was FDA investigators inspecting device manufacturing facilities could use
the app and then release device manufacturers so they can ensure the accuracy of data and
labels before any product enters commercial distribution and final version of the app
would have been available to the public including hospitals, providers, and patients like Terry
Reed's mother this with her implants so they can look up medical device and report data
issues back to us.
(indiscernible) we conducted interviews with target end users and learn more aboutment
so of our assumptions.
For example when when we envision inspections at FDA manufacturing we imagined with U DE
on labels -- an FDA could choose one off the shelf and scan with our app but we learned
most of the time medical devices aren't present at manufacturing facility to inspect.
So maybe this will fill in order, manufacturer might do a production run and immediately
ship out the finished devices but products would be on label aren't sitting normally
at a site to inspect.
So FDA investigators verify quality systems are in place at manufacturing site and that's
the focus.
Scanning with UDI is a secondary focus for them.
We interviewed several manufacturers who he would to us they check the labels against
their own system, not FDA database but their own database they trust which is not totally
surprising.
So we're focusing on giving -- when they first submit to our database so perpetuate data
forward in their own systems -- perpetuate data in their own systems.
That's how they operate and this provides after the public are already a couple of UDI
apps that are available and we tried them and on our team sent one of them feedback
and they implemented the corrections she suggested.
-- suggested which is cool.
And anybody can search UDI on our public website, access GIDID and the mobile version.
So this is a brief overview what we did and learned in ignite but to sum up, it's valuable
we didn't invest money that would end in a brick wall.
And not as useful as we imagined and we have a beared understanding of a -- better understanding
that we're tacking on numerous fronts.
Enhancement to the software FDA investigators use, streamline data updating for labelers,
and data quality tools that can be used by device laborers and the public.
So take a different form will carry ignite design thinking methodology with us and use
those strategies to test out new ideas and continue our work that way.
Thank you.
[Applause]