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.)
If you want to read up on this, you can get it from the source (FDA) and you can get additional information over at Strip Safely.
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I am encouraged by the FDA’s draft guidance on MDDS.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The draft guidance seems to be focused on data provided by MDDS to healthcare professionals.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.
Which web browsers can be used to access CareLink Personal software?
The system is currently validated to work with Microsoft® Internet Explorer® version 7, 8 and 9, Internet Explorer 10 Desktop, Apple® Safari® 4, 5 and 6, and Mozilla® Firefox® 5.0.1. Other browsers might still work although Medtronic Diabetes is not able to guarantee proper operation of those browsers.
I use a Mac. (According to Dexcom, I’m already a complete loser, as their CGM software won’t even run on a Mac unless you use a PC emulator program.) I have two browsers downloaded on my system: Safari (which comes standard on most Macs) and Firefox (which is easily downloaded and what I use occasionally for some banking transactions that demand Firefox).
I know that CareLink works on a Mac, because I’ve uploaded my pump data before on this laptop. So, the other evening, when I needed to upload data so that my trainer and I could look at it together while talking on the phone to adjust settings, I thought it would be easy.
I got this screen when I went to Medtronic’s CareLink link on their website:
My Safari was “too up-to-date”, so I couldn’t access CareLink through that browser.
Well, shoot. OK. Fine. I’ll fire up the Firefox browser I have… Version 21. (Not Firefox 5.)
And by the way, if I wanted to download Internet Explorer right now, it’s IE 10 - or 11. And wait, they don’t have a version for Mac.
If I didn’t have an amazing husband who is a web developer and happened to be home and was willing to sacrifice a pocket protector to the Geek God, I would have been not been able to upload my data. (He somehow configured something and magically, I have a Firefox browser that is…workable.)
I was able to examine the data that I uploaded, but I can’t imagine how frustrating it must be for others who expect that along with the latest technology they get from Medtronic, they get an upload system that will only work with the browsers of yesterday.
Yes, I expressed my opinion to the support team at Medtronic. I was polite, but I did use the phrase: “Unacceptable.” People who know me smile, as that means I’m pretty angry.
Will they do anything? Time will tell, which is pretty much been my phrase about this experience. What I do know is that it takes just one web developer to fix it and make sure that it works with all systems when there is an upgrade… I’m sure they can spare someone in their IT department.
Like I told you before, Medtronic, while allowing me to trial the system and all that comes with it, does not expect that everything I say will be rainbows and glitter about my experience.
The diabetes community talks incessantly (and I believe, sometimes to the wall) about the crucial need for integrated technology to make our lives easier to manage our diabetes. The Medtronic MiniMed 530G with Enlite is an integrated pump and continuous glucose monitor (and that threshold suspend, which I’ll write about soon… promise), but it’s an utter fail if you can’t use the browser… or two browsers…. or system… that you have to review the data and reports. Fail. (It’s not just Medtronic… Dexcom has failed me, too.) What good is the data if you can’t get to it?
Heads up, Medtronic IT department. Please update your CareLink application and browser compatibility. (I’m not going to even talk about Chrome, which you supposedly don’t support at all…)
P.S. I’ll write about the actual reports that CareLink provides in another post. They do deserve a post of their own. But jeez.