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Last active October 18, 2018 17:51
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community, MDR, FDA oversight

Community and MDR

The FDA enforces science and data driven standards to promote and protect public health and safety. One of the ways they perform their job is by providing oversight of all products available to the public. One way they acheive "oversight" is through "post market surveillance," in other words monitoring how devices perform, with a special focus on potential or actual harms or injuries. In other words, FDA is deeply committed to the idea that "vendors" who create a device should know and report performance, safety and effectiveness data even when a vendor ceases to make or sell a device.

https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm359566.pdf

The FDA has guidance for how this works in practice. Anyone can submit an MDR, a Medical Device Report.

Loop/Openaps/DIY

The FDA has repeatedly requested assistance from the community and vendors in achieving oversight, one way or another. In the event a pump malfunctions, gives dangerous doses, regardless of whether or not Loop or Openaps was involved, the FDA needs to know so that future regulations can be designed to fit the needs of the market.

How can the community engage?

A. Install MedWatcher App

FDA has an app called MedWatcher. It assist in reporting events. Grassroots, everyone would do this on their own.

B. Automate Reporting Safety Events

There's a natural alignment between our community's desire for safety and the FDA. The DIY community uses open source tactics to ensure the community has oversight over the software they depend on. Similarly, the DIY community and FDA both benefit from ensuring easy to use tools to discover and irradicate quality and safety issues.

The FDA, as part of their Electronic Service Gateway has a service called eMDR. The community could use this API to report events directly from a mobile application like Loop, or from a purpose built tool in Nightscout, or from a research data-mining project like Openaps Data Commons. Consider a community built tool, that given access to the Facebook group, can quickly identify and assist reporting unusual or unsafe events so that a potential responsible entity can provide our community and FDA with an appropriate understanding of how devices perform.

IMHO, this is by far the best option, understanding that it takes resources that may not be available.

C. Ignore

The FDA has a mandate to provide oversight, and is requesting help from community and vendors. If the community does not assist FDA in acheiving oversight, then FDA is left only with vendor provided solutions.

What happens after?

Members of the public submit MDRs on a voluntary basis. The regulations indicate that it is mandatory for Medtronic to report any device failures on 522, 722 or similar pumps, event though they do not make them anymore.

Escalating to hold the vendor accountable may yield disclosure of additional data and documentation regarding the pumps. However, aggressive (legal) pursuit to hold Medtronic accountable could open counter-suits, potentially against authors in the community as the vendor seeks to defend itself.

The vendor's response to this kind of complaint may be useful in it's own right, to see if they file and MDR as they are supposed to. They will likely recommend their newer, supported product.

Hopefully the future holds better choices.

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