Repost from Medical Device Problems
by Amanda Dykeman
Find out the specific name of your device
Before beginning your research, ask your physician to print out for you the specific name of the device at hand and its manufacturer. You will need this important information throughout the research process.
As you get ready to begin your research, it’s important to organize yourself and create a central place to save and store all necessary files, such as google drive or Dropbox. It should be an online location that is easy to access and share by different people in your group.
File a FOIA request for anything and everything on that device
You can file a FOIA (Freedom of Information Act) request with the FDA. Be as specific as possible and file multiple requests in different offices. For example, the original manufacturer of the Essure device, Conceptus Inc, was headquartered in Mountain View, California. I knew that prior to obtaining a license to manufacture their medical device, they had to undergo an inspection by the local Department of Public Health, so I filed a FOIA request with that office as well. Do some research to determine who manufactures your device, where they are headquartered, and which public office is in charge of inspecting and licensing them. Every government office has a Freedom of Information Act division to process your requests either electronically or by mail.
What is a FDA Form 483 and why is it important
One document I would specifically ask for in a FOIA request is any and all FDA Form 483s issued to a device manufacturer. These forms usually cite violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. Observations are made when in the investigator’s judgment, conditions or practices observed would indicate that any device has been adulterated or is being prepared, packed, or held under conditions whereby it may become adulterated or rendered injurious to health. You can find more information about 483s here. You may also be able to find warning letters issued to medical device manufacturers here.
How to get clinical trial information
ClinicalTrials.gov is a database of privately and publicly funded clinical studies conducted around the world. It is an easy resource to find any clinical trials that have been done on specific devices. If your device is a Class II and approved under the 510K process, it is likely there may have been very little to no clinical trials done. You may need to visit FDA.gov and type “device name/510K” in the search bar or go to a direct search. Because devices approved under the 510K process only need prove they are like predicate devices, you may have to follow a very long trail of devices to get to the original device that may or may not have clinical trial information.
How to get FDA meeting minutes for approval
Getting the meeting minutes for approval of a Class 3 PMA device is as easy as visiting fda.gov and doing a quick search. Type in meeting minutes, and the device. You may also obtain these minutes via FOIA request.
How to check for conflicts of interest
Follow the money trail! I have used this resource to do a company search, and then see if there are specific investors that may have underlying conflicts of interests. In addition, the Open Payments Search Tool is used to search for payments made by drug and medical device companies to physicians and teaching hospitals. Honestly, Google and DuckDuckGo are two search engines that can help you the most when trying to find conflicts of interest within an organization. All you need are the right keywords. I have always used the person’s or organization’s name along with “lobby disclosures”, “conflict of interest forms”, or “Form 990s” (which are financial disclosures for nonprofits). “Paid consultant” is also a key phrase. The process can take a bit of trial and error until you find the most accurate search terms.
Other helpful sources of information
The United States Patent and Trademark Office can help you find the patent of a specific device, and provide a wealth of information regarding materials used and the manufacturing processes.
Doing a company search on United States and Securities Exchange Commission can provide you with so much valuable information. By law, manufacturers of medical devices (and other companies) are required to provide accurate and up to date information pertaining to their business in order for investors to make informed decisions. This includes any risks associated with the manufacturing of any specific device.