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Data available for medical device safety studies?


(Helen Ying HE) #1

Hi OHDSIers Greetings!
May I ask a question, maybe very beginning stage like throwing a stone in the lake:
Do we have suitable CDM and any data available in OHDSI community, to conduct device safety studies? Any progress? What are the development stage now?

For instance some registry database (NJR in UK, other EU databases) or government data sources (e.g. CFDA and regulatory affairs they own the data, which is common for China) and hospital data of surgery and procedures which might give a hint to the use of medical device, for instance knee/hip replacement devices, cardiovascular devices, plastic surgery devices/implants…etc?
Is there any possibility or promising future for us to work on a CDM?
Please do feel free to correct me if I understand not clearly or sth- open discussions and suggestions are highly appreciated!
Thank you very much all!
Helen from Oxford Uni NDORMS

(Asiyah Lin) #2

HI Helen,
We just formed a device working group to find people who are interested in the medical device related research. Please shout over there:


(Anna) #3

I used to work with medical error evaluation for devices. The databases I worked with weren below in my recall, hope it useful.

  • Manufacturer and User Facility Device Experience Database (MAUDE)
  • The National Coordinating Council for Medication Error Reporting and Prevention (NCC-MERP)

(Asiyah Lin) #4

Thank you Anna!
MAUDE is the FDA released Medical Device adverse event reports. There are a lot of safety data to mine.
I didn’t know about NCC-MERP, which check it out.

(Dan O'Leary) #5

I did an initial analysis of the MAUDE database for 2018 to identify the most frequently reported product codes and the most frequently reported regulations (based on the product codes). My analysis is in an attachment to an earlier post.

There was a proposal to look at data from 3 or 4 hospitals, but I don’t know the status.

My original thought is that the MAUDE analysis would suggest devices of interest to others as part of the proposed study. People with a specific interest area would want to know more about the devices most frequently reported in MAUDE.

My interest is in understanding the use of UDI in general and the UDI-DI in particular. My expectation is that patient level includes the UDI of devices used and that the data from the hospital study would provide the UDIs.

My second interest is in user facility reportable events as required by 21 CFR Part 803. We may not know if the user facility reported the event, but the frequency of reportability would be useful.

Clearly the analysis of regulation, product code, UDI-DI, and reportability could provide valuable information.

We had an initial call, but I don’t believe that have been subsequent calls nor a call schedule.

(Asiyah Lin) #6

@doleary, the Medical Device WG is still in the preparation phase, thus, it’s quiet now.
@helenhy Can you specify the question you would like to ask if a dataset and CDM is available?