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New working group: Medical Device Working group

(Kin-Wah Fung) #41

Hi, I’d like to participate. I’m familiar with device terms in SNOMED CT and GMDN.

(Vojtech Huser) #42

The notes from today’s meeting are in the running notes google doc linked from https://www.ohdsi.org/web/wiki/doku.php?id=projects:workgroups:devices

(Dan O'Leary) #43

There is a thread name IUD Study Updates. It appears to have three cohorts related to different types of IUDs.

Since an IUD is a device, I wonder if the IUD study includes device specific information valuable to this group. Also, is there an opportunity to include other device specific information based on the interests of this group?

(Vojtech Huser) #44

Due to COVID-19 study-a-thon and other covid tasks, I will not be able to lead the meeting (and provide the webex room for it). If rest of the group still wants to meet anyway, please coordinate via this thread (or email).

(Eduard Korchmar (Terminologist @ Odysseus Vocabulary Team)) #45

Hello everyone! Writing here, since I could not locate a dedicated Device WG channel.

We have recently started conversation with International SNOMED CT team. One of their short term goals is improving their own Device hierarchy. They are looking for external feedback and usecases.

Given that SNOMED is our de-facto standard for mappings for Device domain concepts (however little standardisation there is made now), we are interested in providing data for them and cooperating on making SNOMED’s device hierarchy the most suitable to OMOP CDM users needs.

Main two questions we were asked by SNOMED:

  1. What types of Devices are of most interest to community? E.g. what devices are to be subjected to observational research.
  2. What types of Devices are most often encountered in source data? Especially if they map or can be mapped to SNOMED CT concepts.

SNOMED team needs answers to know where to focus their efforts first.

(Leilei Zhu (Clinical Data Standards Lead, UCLH, UK)) #46

Hi, in the UK, we use dm+d (drugs,medication and devices) as the data standard for devices.

(Dan O'Leary) #47

I’m a consultant working with medical device manufacturers. I’m interested in the use of UDI information at the facility level (inventory management) and at patient level (EHR). From previous discussions, I understand that UDI information is rarely, if ever, captured in EHR data.

I was asked about patient labels, little labels often stuck to charts. The question is in a few parts:

What should be on such as label?

Is there a common expectation across hospital for the label layout and content?

Is there a standard that defines the label?

Should the label include the UDI or, at least, the UDI-DI?

Does the label content get into the EHR and could be used to identify the device for some kind of comparative analysis.

(Dan O'Leary) #48

Will there be a meeting on May 28, 2020?

(Vojtech Huser) #49

May 28th meeting is cancelled. (due to COVID-19 research tasks of some of us)

(Asiyah Lin) #50

Hi all,

We are planning for the next meeting on July 23rd (in two weeks), 10AM-11AM ET.
Please block your calendar for the time if you will be available to join.

Tentative agenda:

  1. Introduction of UDI
  2. Updates on COVID19 related medical device RWE or other activities – how OMOP capture the device exposure, such as ventilators.

Please suggest the topic you will be interested to discuss with the group.


(Vojtech Huser) #51

Comment here if you consider it important

Meeting will use Google Meet. link is at this page https://www.ohdsi.org/web/wiki/doku.php?id=projects:workgroups:devices

(Vojtech Huser) #52

regarding the SNOMED POST above - @Eduard_Korchmar- Can you talk about it more at the next meeting. Or give update. (since April)

Also, is there perhaps a link to the Device team of SNOMED CT that you can share? (or provide who you talked with at SNOMED International?)

(Vojtech Huser) #53

Thank you for all who came to our meeting this week.
Meetings from the call this week are at the usual place (google WG folder -> meeting notes)
Slides and audio recording of the call are also in the WG folder. See below.

Terrie gave a great presentation and we had a nice discussion afterwards.


(Paul Coplan) #54

Hello Vojtech and Asiyah,
Can I please join this workgroup? Do I have to sign up?


(Asiyah Lin) #55

@Pcoplan, your message is enough for the sign-up.
Welcome to the group!

(Asiyah Lin) #56

To the whole WG:
Next Thursday’s (Sep. 24) WG meeting (10AM - 11AM ET) is on. Barry Daniels from GMDN is scheduled to provide us an updates on GMDN.
We might change the meeting invite link. Please stay tuned.

(Asiyah Lin) #57

To the whole WG:
Tomorrow meeting’s agenda:

  1. Introduce new members (10 min)
  2. Dr. Barry Daniels’ talk: GMDN – an introduction and update (30 min)
  3. Questions and updates from members (20 min)

Meeting time: 10AM -11AM (New York Time)
TELECONFERENCE webex link: https://nih.webex.com/nih/j.php?MTID=m88b1ba82c0574344923913ae251eb9f5
Meeting password: Talk2omega

(Dan O'Leary) #58

Based on the Sep. 24, 2020 meeting I have a few questions.

The GUDID-Data-Elements-Reference-Table dated April 27, 2020 describes the use of either GMDN codes or FDA PT Codes. “Each device record must have at least one assigned GMDN Code/FDA PT Code”.

Is there data on the number of records with a GMDN Code and the Number of records with an FDA PT Code. Depending on the proportion, analysis by GMDN code only could result in a significant undercount.

In the discussion we learned that the GMDN codes are not static; there is refinement as new conditions arise such as the breast implant example. Do the FDA PT Codes change when the corresponding GMDN codes change?

My understanding is that when a GMDN code becomes obsolete and there are new codes (as in the breast implant example) the device manufacturer does not update the GMDN or the FDA PT Code for the change. Does anybody else update the codes in the DI record?

If not, this raises a data analysis question because GUDID could have a large number of codes that were valid when entered, but are now obsolete. Is there data on the number of active records (In Commercial Distribution) with obsolete codes?

(Patricia Mays) #59

Hi Asiyah,
I am interested in joining this working group.
Thank you!

(Asiyah Lin) #60

Sorry, all. I am not following this thread at all. My bad.
For whoever wants to join the group, please check the Device WG page, and add your contact to the google doc link provided in the Device WG wiki page.

PS: I will disband from FDA and join NIH onwards. This AsiyahFDA may not be in use soon.