This is a last minute push to get comments on the FDA docket currently out for medical devices. You have until 11:59pm ET Monday, August 25th to get this done.
Two minutes. That’s all it takes.
What is MDDS?
Medical Device Data Systems.
These are systems that, in the FDA’s words, facilitate
“the electronic transfer or exchange of medical device data from a medical device, without altering the function or parameters of any connected devices.”
Think about your Dexcom information on an iPhone or a tablet or a computer or a smart watch. Think about seeing boluses in real time. Think about being able to view medical data NOT on the device itself. For parents of kids with diabetes… kid is at school and mom or dad can see BGs in real time.
FDA thinks that this type of technology doesn’t introduce much additional risk, so they want to lessen the regulatory process (i.e. red tape) for these devices.
We totally agree.
However, FDA isn’t clear on the topic of “active patient monitoring”, so our goal is to encourage the FDA to
- Specifically address the importance of giving patients access to their own health data on multiple devices/screens (the more access the better), and…
- Clarify whether CGM-related technologies will be included in the MDDS relaxed regulatory process. (We believe they should be.)
This is what you can do RIGHT NOW:
1. Copy the information below.
I am encouraged by the FDA’s draft guidance on MDDS. I support the FDA’s position that technologies that transport data, without changing values, are low risk. I believe that access to medical data should be available on multiple platforms that are accessible to both medical professionals and patients. Access to this type of data is becoming increasingly essential in healthcare, with the potential to reduce costs and improve outcomes – in fact, not having timely access to needed data poses a far greater risk. I strongly support access to this type of data and am pleased to see FDA recognizing its importance.
People living with diabetes depend on data in order to minimize the chance of life-threatening complications that can arise with very little warning.
The draft guidance seems to be focused on data provided by MDDS to healthcare professionals. It should be modified to also explicitly state the value of access by patients, particularly for chronic conditions like diabetes where patients need access to their own data to manage their own care as safely as possible.
The draft in section V-B seems to precludes active patient monitoring. Specifically how or if this impacts diabetes is unclear. A clear definition of active monitoring should be included in the guidance. I strongly suggest that real-time access by patients to their own data *not* be defined as active patient monitoring. I strongly support including in this guidance more open access to information from continuous blood glucose monitoring for patients with diabetes. The appropriate risk of device performance is regulated through the device PMA, and shifting CGM data to secondary screens does not in any way increase risk. From a patient perspective, secondary screens significantly decrease risk by making information more readily accessible to the patient. This is particularly relevant for those of us who may be unaware of early stages of hypoglycemia.
ER and Hospitalizations:
Geller et al estimate in JAMA (JAMA Intern Med. 2014;174(5):678-686. doi:10.1001/jamainternmed.2014.136.) that almost one hundred thousand Americans a year are treated in the Emergency Room for insulin related hypoglycemia and that about one third of those are admitted. Timely access to real time sensing data may help prevent many of these ER visits. This suggest real opportunity to mitigate risk through secondary device display of CGM information.
Multiple Data Sources:
Existing regulations state that ‘Accessories to classified devices take on the same classification as the “parent” device. An accessory such as software that accepts input from multiple devices usually takes on the classification of the “parent” device with the highest risk, i.e., class.’ (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm142651.htm ) People managing diabetes often use multiple devices to provide the data needed to follow care instructions. Bringing that data into a single application would improve patient understanding. For example finger stick measured blood sugar, CGM trends, amount of insulin infused, and the time of each are all information that patients juggle. A dashboard displaying all relevant diabetes data would improve safety and reduce risk, compared to forcing the patient to consult multiple devices and displays.
FDA’s Dr. Courtney Lias offered promising comments on diabetes and mobile devices at the Keystone 2014, “Practical Ways to Achieve Targets in Diabetes Care” sessions. Closer Look reports that Dr Lias, in comments on artificial pancreas, spoke of a strong FDA interest in consolidating devices through mobile technology to facilitate better diabetes care. She reportedly spoke of “component artificial pancreas system,” where patients could choose component devices of a system. I fully support the vision Dr Lias shared. This proposed MDDS guidance can encourage logical, safe and incremental steps towards that future by opening multiple diabetes devices to display on a mobile devices.
Diabetes patients implement the individualized care programs created by our doctors based on real-time data from multiple FDA-approved medical devices. Easing the accessibility of data from those devices improves our ability to follow our care team’s instructions. I support the FDA’s adoption of MDDS guidance that incorporates a nuanced appreciation of the low risk and incredible value in using MDDS to transmit and display diabetes data.
2. Click here and paste the copied comment into the comment box. Wanna get fancy? You can add why this is important to you. There’s a 5,000 character limit, so you’ll need to delete some of the copied comment, but they’ll get your gist.
3. Then do this.
- Fill out your information. You’re commenting as an individual so UNCHECK the box that says:
- “I am submitting on behalf of a third party”
- Click the Category, “Individual Consumer”
- Click continue.
- Review, check the confirmation box
- Submit your comments. You even get a receipt to confirm your comments were posted.
4. Do a little dance and high five yourself. You just raised your voice for diabetes advocacy. You rock.