In this edition of Tech Notes, I will cover three recently released medical apps. Two of them are from medical societies and provide great value to their members. Both of those are free to download and critical for their particular specialties.
I’ll also dive into the difference between an FDA "approved" medical app and an FDA "cleared" medical app, and how the FDA has opened up a new regulatory pathway for medical apps that allows them to market their treatment benefits in a way that was not possible before.
There has been a lot of unfortunate news recently on how maternal mortality in the United States after childbirth has been increasing. The increase has been dramatic and has been highlighted in many mainstream news publications, with some numbers showing an almost doubling of maternal deaths per 100,000 live births since 1987.
Although the dramatic increase might make researchers think the underlying pathology has changed, it hasn’t. There are still three main causes of maternal mortality worldwide and in the United States: postpartum hemorrhage, severe hypertension of pregnancy, and venous thromboembolism.
The Safe Motherhood Initiative (SMI) is a project of the American College of Obstetricians and Gynecologists (ACOG) District II. SMI started in 2013 and works with over 10,000 health care providers and 118 birthing facilities to help develop a standard approach to handling obstetric emergencies associated with maternal mortality and morbidity.
The application itself contains position statements, guidelines, checklists, algorithms and teaching slides. You are able to highlight and bookmark key bundles and checklists. An interesting feature of the app is the ability to leave feedback. If you click the star icon within a document, you are able to give ratings on the actual content. There is an additional section for leaving detailed text feedback.
My only criticism of the app is in the lack of conversion of the PDF files. The actual content is presented in PDF forms. While the PDFs themselves are relatively easy to read on a mobile device, it would have been much better to convert the PDFs into a native iOS or Android format for reading.
Overall, it’s great to see ACOG’s District II take on such an important task and help standardize management of the main causes of maternal mortality.
The Society for Pediatric Anesthesia (SPA) created Pedi Crisis 2.0, a medical app that has peer-reviewed algorithms for treating 26 pediatric crisis situations. Not only is there specific treatment advice, but the application also contains checklists and differentials.
Pedi Crisis allows you to enter the weight of the pediatric patient you’re taking care of, then gives you specific dosing advice throughout the app. The application has a really interesting user interface, with a host of hyperlinks throughout that allow you to jump around the pediatric crisis situations.
A lot of thought went into the user interface, shown in the "phone numbers" section. Instead of just having a blank screen for providers to input key numbers, the application gives you specific sections and categories for the phone numbers, such as "code team," "blood bank," "ECMO" and more.
Almost all medical societies have algorithms and treatment plans they give guidance on, and it would be great to see more of them getting into the mobile space by providing value add mobile apps such as Pedi Crisis.
Natural Cycles is the first FDA-cleared mobile medical application that can be used as a method of contraception to prevent pregnancy. It’s important to note the mobile application isn’t "approved," but "cleared." This means the FDA is allowing the application to market this specific medical use.
Why does the FDA stamp matter here? The story is actually pretty interesting. The FDA reviewed the Natural Cycles app through the new de novo premarket review pathway. This is a regulatory pathway for novel, low-to-moderate risk devices of a new type.
This now allows mobile medical apps to go through the FDA’s 510(k) process, allowing them to obtain marketing authorization for their claims.
Natural Cycles contains an algorithm that calculates the days of the month a woman is likely to be fertile based on daily body temperature readings and menstrual cycle information. This is a type of contraception referred to as fertility awareness. The daily body temperature reading is based on a basal body temperature, which is the lowest body temperature attained during rest (immediately after awakening).
The Natural Cycles app algorithm was originally created by nuclear physicist Elina Berglund Scherwitzl, a Nobel Prize winner. The app launched in 2014, and there have been several studies performed that test the efficacy of the application and algorithm. Overall, this is definitely an interesting medical application with solid research to back it up. The app claims to be 93 percent effective under typical use, meaning that 7 out of 100 women get pregnant during one year of use - so there are definitely several cases of unintended pregnancy.
There is a subset of women who are interested in non-hormonal methods of contraception, and this app could be appealing to them, as long as it’s made clear to patients that it’s not superior to traditional methods and that unintended pregnancy can occur.
Iltifat Husain, M.D., is editor-in-chief and founder of iMedicalApps.com, the leading physician publication on digital medicine. He’s also assistant professor of emergency medicine and director of medical app curriculum at Wake Forest School of Medicine.