The world we now live in

While we continue to worry about the coronavirus a new concern has popped on the diabetes device horizon. Given that all the toys now talk with the cloud and the other toys the FDA seems to be taking a more active role in regard to cybersecurity. Yesterday the FDA issued the following release;

“Today, the U.S. Food and Drug Administration is informing patients, health care providers and manufacturers about a set of cybersecurity vulnerabilities, referred to as “SweynTooth,” that – if exploited – may introduce risks for certain medical devices. SweynTooth affects the wireless communication technology known as Bluetooth Low Energy (BLE). BLE allows two devices to “pair” and exchange information to perform their intended functions while preserving battery life and can be found in medical devices as well as other devices, such as consumer wearables and Internet of Things (IoT) devices. These cybersecurity vulnerabilities may allow an unauthorized user to wirelessly crash the device, stop it from working, or access device functions normally only available to the authorized user.”

The release goes onto state;

“Medical devices are becoming increasingly connected, and connected devices have inherent risks, which make them vulnerable to security breaches. These breaches potentially impact the safety and effectiveness of the device and, if not remedied, may lead to patient harm,” said Suzanne Schwartz, M.D., MBA, deputy director of the Office of Strategic Partnerships and Technology Innovation in the FDA’s Center for Devices and Radiological Health. “The FDA recommends that medical device manufacturers stay alert for cybersecurity vulnerabilities and proactively address them by participating in coordinated disclosure of vulnerabilities as well as providing mitigation strategies. An essential part of the FDA’s strategy is working with manufacturers, health care delivery organizations, security researchers, other government agencies and patients to address cybersecurity concerns that affect medical devices in order to keep patients safe.”

We hate to say we told you so, but we have been advising caution as we move towards the interoperability of diabetes devices. This is particularly true for the growing group of hybrid closed loop insulin delivery systems, systems which can and do dose insulin WITHOUT patient interaction.

This also reinforces something else we have been saying the importance of having an accurate and reliable CGM sensor. We further suspect given the FDA’s heightened awareness to this area that we won’t be seeing the Libre2 from Abbott anytime soon. We already know that the Medtronic CGM sensor has performance issues, issues which have led to numerous serious adverse events for patients on the 670G.

Abbott was initially extremely confident that the Libre2 would not only receive FDA approval but be approved with the iCGM designation. The company has since backed off these comments and seems resigned to the fact that Libre2 will not be approved anytime soon. Insulet did note in their recent earnings call their new deal with Abbott is contingent upon the Abbott sensors receiving the iCGM designation.

Now we’re sure there are some in diabetes toy land who believe we are overly conservative about this issue and they would be 100% correct. First there is absolutely no need to rush any of these products to market. There is nothing wrong with the toy’s patients have to play with. Second, and really it should be unnecessary to say this, but people seem to either forget or ignore the fact that while insulin may be a life sustaining drug it is also a LETHAL drug when dosed improperly.

Frankly it is highly disturbing the cavalier attitude taken by so many out in diabetes toy land. We for one applaud what the FDA is doing just as we applaud Insulet for halting the Horizon studies while they fix their software issue. This is also reason we have condemned Medtronic for their handling of their sensor issue. When it comes to diabetes toys the first rule should always be the patient comes first. Rule two is to reread rule one.

While we aren’t a proponent of increased regulation, we are however huge proponents of patient safety. This is not like the coronavirus which desperately needs a vaccine. There are plenty of excellent diabetes systems on the market. This is not a matter of having an unmet medical need, the need has been met already. Yes, these newer systems will help the patient but it’s not like patients are hurting today while these systems are being developed.

Bottom line here is you don’t get a second chance when the system incorrectly doses insulin. There is no such thing as a do over. As we have seen when the 670G fails and/or malfunctions it’s one and very done. Think about that!