September 10, 2012

Please Respond to These Patient Advocate Question at Linked

Hi Friends

Here is a chance to share you views with the FDA through a patient advocate:

Here is the post from Linked In. 
Hi All - Through my role as a diabetes patient advocate/advisory committee member with FDA, I was invited to participate in a series of FDA meetings about setting up a process for doing medical device comparative effectiveness research and post-marekting surveillance. FDA is working on creating a system to collect and analyze medical device data that will provide a way to understand/monitor the safety and the "comparative effectiveness" of medical devices, once they have been approved and are on the market. My role is to provide the patient perspective on the development of the program and give input into the type of information patients need/would like to have about medical devices.
I would love to get your input, so that I'm representing not just my point of view, but that of others within the community. Toward that end, I've posted a couple of questions below. I would love to get your responses to the questions, as well as any other input you might have on the topic. 
For those of us with type 1, our lives depend on our devices. I'm hoping you'll take a couple of minutes to help me include your voice in my remarks. You can respond privately via linked (or her email linked there). Thanks so much! - Anna
Where do you get information about the medical devices you use to control your diabetes?
Have you ever searched for information on safety/effectiveness of your pump and/or meter?
Have you ever had the sense that a lack of information about device safety/reliability affected your treatment decisions and or health care?
If you have had meter/pump malfunctions in the past, have you ever reported your malfunction to:
-FDA's Medwatch Web site?
-Your doctor?
-Your device manufacturer?
Have you ever changed devices (pump or meter) based on issues related to device reliability, malfunctions or errors?
If so, where did you go to find information about the new product you selected?
As a patient/caregiver, are you aware of any diabetes device registries where you can access information about diabetes device safety/relative effectiveness?
As a patient/caregiver, if the government and industry were working to create a nationwide device database:-What types of information would you like it to provide?-Would you want to be able to access the information directly?-Would you prefer to rely on medical researchers/diabetes societies to fund research based on the registry database?

1 comment :

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