Low Risk

Med Device Monday: Safer C-sections

Many medical conditions and complications can be and are diagnosed ahead of time, resulting in planned cesarean sections. Of course, emergencies still happen, and in fact, the National Institutes of Health reports that there has been a rise in the numbers of both elective/planned c-sections, and second stage c-sections in the past 20 years.  

The second stage of labor is the point in delivery when the cervix is fully dilated, and the baby is making its way through the vagina and out into the world. While only 1-3% of c-sections occur at this point in the process, they are, as you might imagine, more dangerous and potentially traumatic for mother and child. When the baby's head may already be in the birth canal and doctors have to reach farther into the body, risks are higher and include tears or damage to the cervix, vagina, and uterus, hemorrhage, and extended hospital stays. 

In fact, some reports are that up to 57% of mothers who have a second stage c-section experience some of these complications. 

Fetal pillow is a new medical device from Safe Obstetrics, and it aims to reduce these complications by getting the baby's head out of the birth canal prior to a second stage c-section.

Photo from safeobstetrics.com.

Photo from safeobstetrics.com.

Fetal pillow consists of a small inflatable device that is inserted into the vagina, and then moved down below the baby's head, between it and the coccyx to prevent injury. An attached tube is used to fill the "pillow" with saline and push the baby's head out of the birth canal and back into the uterus. 

When used correctly, this simple, Class II prophylactic device can result in safer, easier births with better patient outcomes for both mother and baby. It reduces complications and length of hospital stays, cuts down on blood loss, and reduces chance of injury to mother and child. 

I love seeing devices like this come into the marketplace! A true win for all in the form of a beautifully simple and effective solution.


Further reading:

Fetal pillow device classification

You can see actual footage (warning: this is not a cartoon) of the fetal pillow being used during a live c-section

Med Device Monday: A Medical Device for Substance Use Disorders

When we think of treating substance abuse, it's typically drugs, therapies, and various rehabilitations that come to mind. But last week, FDA announced that it has approved marketing of the first medical app (yes, like the kind from the App Store) to help treat Substance Use Disorders (SUD). The device is intended to be used together with outpatient therapy, and it's not intended for use with opioid addiction or for those who are dependent only on alcohol. But still, medical treatment through a mobile app? It's hardly the first time we've said it here, but the future truly is now!

Substance Use Disorder is, in a word, addiction. The Substance Abuse and Mental Health Services Administration shows a group of disorders that fall under this title, including dependence on alcohol, cannabis, tobacco, stimulants, and hallucinogens. Note that they also make clear distinctions about the words they choose to describe these disorders, saying, "The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), no longer uses the terms substance abuse and substance dependence, rather it refers to substance use disorders, which are defined as mild, moderate, or severe to indicate the level of severity, which is determined by the number of diagnostic criteria met by an individual." They go on to say, "Substance use disorders occur when the recurrent use of alcohol and/or drugs causes clinically and functionally significant impairment, such as health problems, disability, and failure to meet major responsibilities at work, school, or home. According to the DSM-5, a diagnosis of substance use disorder is based on evidence of impaired control, social impairment, risky use, and pharmacological criteria.".

Of course, most of us will unfortuantely have at least a passing familiarity with what substance dependence means and looks like. All the more reason that an accessible mobile medical device for treatment is fantastic news. 

reSET Pear Therapies addiction app
Screencaps from peartherapeutics.com

Screencaps from peartherapeutics.com

reSET, from Pear Therapeutics, is the name of this app, which is used on a patient's phone or tablet and monitored by their clinician via a desktop interface. It's designed to encourage and maintain abstinence from the substance the patient is dependent on. It delivers to the patient cognitive behavioral therapy (CBT) and acts as part of a larger overall plan of treatment. In fact, in clinical trials, treatment via reSET saw better outcomes than those patients who used only traditional, in-person therapy. CBT is a system of talk therapy designed to make the patient aware of negative or destructive patterns of thought and change their behavior around them. 

While this medical device is, like any medical device, not a magic bullet, it is really encouraging and exciting to see how technology can serve patients and the medical device community. This is a really promising development and I look forward to following this company and this device in the future. Check out the other devices they have on deck which have not yet been approved, by clicking here.


Further reading:

FDA's de novo approval

Pear Therapeutics press release

FDA press release: FDA permits marketing of mobile medical application for substance use disorder

Med Device Monday: Converting Anesthesia Waste into a Renewable Resource

We took last week off for the Labor Day holiday, but we're back! And we're extending our August post theme of cool but not-yet-FDA-approved medical devices in order to feature one last device that we just couldn't resist sharing.

Technology in medical devices is a topic we are very interested in around here. There are so many different ways that technology can be used to make patients healthier and procedures safer. Today, we're looking at a different side of things and talking about one way that technology can turn waste from medical procedures into a renewable resource. Pretty cool, right?

Resthetics is a company working with the Texas Medical Center Accelerator (TMCx), as are all of our devices featured in August. Their device essentially recycles waste anesthetic gas into anesthetic gas that can safely be used in future procedures, in a more cost-effective and environmentally friendly way than producing the same anesthetics from raw materials. What's not to like about that?

Photo from medinstrum.com.

Photo from medinstrum.com.

Per Resthetics, "In 2015, 2.7 million liters of fluorinated anesthetics were released into the atmosphere from United States hospital operating rooms alone. This equates to $1.5 billion worth of wasted anesthetic gas. Fluorinated anesthetics, a type of hydrofluorocarbon (HFC) are potent greenhouse gases and are 4,000 times more harmful than carbon dioxide emissions. They are highly stable and can remain in the atmosphere for up to 20 years, thus contributing to global warming."

So not only would recycling these gasses represent a huge cost savings (which would hopefully be passed on to patients), but it would help the environment. And isn't that the best for everyone's health in the long run?

A little more about how it works:

Their elevator pitch:

Med Device Monday: Nonabsorbent Dressing

Nonabsorbent dressing! No, that's not the name of a band or a gravy-resistant Thanksgiving side dish.

In the medical field, the term is usually "adsorbent", and that's exactly what D2 QuikClot internal bandages are. 

QuikClot bandages from Z-Medica have been on the market for some time. They look like regular gauze bandages in various sizes, shapes, and packages, but they are "coated or impregnated" with kaolin, a clay (natural or made in a lab) that can help induce clotting. The bandages are meant not to soak up blood (though they will do that too), but to actively stimulate clotting. Once the patient has been stabilized, the bandage is to be removed. 

The implications for a product like this are far-reaching. Field sites, remote and rural places, military operations, and even for injuries that happen close to medical facilities but which might be severe. 

Photo from quikclot.com.

Photo from quikclot.com.

Z-Medica recently gained de novo approval for what is essentially a new version of this device. Dubbed QuikClot Control+, these bandages are, per Z-Medica  "...the first and only non-absorbable hemostatic dressing cleared for internal organ space use in severely bleeding patients. QuikClot Control+ is indicated for temporary control of internal organ space bleeding for patients displaying class III or class IV bleeding. It may also be used for control of severely bleeding wounds such as surgical wounds and traumatic injuries."

These bandages are a version of the regular QuikClot that are approved to be used internally. Some might even say they are substantially equivalent! (That's a de novo joke, and not a very good one.). Like their original counterpart, they also look like guaze bandages, and have that same clot-inducing material in them to help stop bleeding with a quickness. The difference here is that they are approved for major bleeding, trauma, and to help with internal injuries.

Class III and Class IV bleeding are classifications of hemorrhage-level bleeding. Class III indicates a loss of 30-40% of circulating blood, while Class IV is 40% or more. A bandage that can stop that type of severe blood loss is pretty impressive.

What's also interesting about this de novo approval is the testing that was required. First, this product was tested only on animals. That might not be the most pleasant thing to think about, but you don't exactly want to wait and test it out on a human patient who's bleeding out in front of you. 

Second, check out this list of considerations and factors to prove when getting FDA approval for a device that, on its face, seems relatively simple:

Screen cap from fda.gov.

Screen cap from fda.gov.

In other words: is this product going to work? Will it cause infection if the sterility isn't maintained? Will it have a negative impact on the surrounding tissues? Will it create complications down the road? Will the patient get an embolism or bleed out later anyway? FDA wants to know what the risks are for your device and then understand how you have mitigated these risks to make it safe and effective.  

This is another good example of a medical device that seems so simple and straightforward—and to some degree it is, as it was granted de novo approval—but which showcases the rigor and thorough thoughtfulness required to get a medical device through FDA!


Further Reading:

de novo approval

Device classification

Z-Medica press release

the de novo pathway: is it right for my device?

Med Device Monday: Class II Device Types Exempt from Premarket Notification

In the first installment of this series, we discussed Class I device types that are exempt from premarket notification (also known as a 510(k)). I certainly recommend you read that post, but to recap: FDA often requires you submit a 510(k) for medical devices in cases where a premarket approval (PMA) isn't required. The purpose of the 510(k) is to show that the device that is going to be marketed is safe and effective because it is equivalent to a device that is already being legally marketed. FDA occasionally issues exceptions to the types of devices they require to have premarket notification. They make these exceptions essentially because they believe the devices are understood well enough that premarket clearance isn't necessary, and so exempting them will save everyone a bit of time and money:

"The FDA believes that the device types identified in the Federal Register are sufficiently well understood and do not present risks that require premarket notification review to provide a reasonable assurance of safety and effectiveness. This action will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with Federal regulation. " 

You can read a more about their philosophy behind their exemptions in much more detail here, but that's the gist of it: they really do want things to be as safe and efficient as possible for patients and industry alike.

Last week, FDA released their latest missive on Class II exemptions

Here's your refresher on the distinction between classes:

"FDA classifies medical devices based on the risks associated with the device. Devices are classified into one of three categories—Class I, Class II, and Class III.

Class I devices are deemed to be low risk and are therefore subject to the least regulatory controls. For example, dental floss is classified as Class I device.

Class II devices are higher risk devices than Class I and require greater regulatory controls to provide reasonable assurance of the device’s safety and effectiveness. For example, condoms are classified as Class II devices. 

Class III devices are generally the highest risk devices and are therefore subject to the highest level of regulatory control. Class III devices must typically be approved by FDA before they are marketed. For example, replacement heart valves are classified as Class III devices."

So this time around, with Class II exemptions, we're looking at more complicated things than dental floss. Here's a snapshot of some of the items that are on the "no longer require premarket notification under section 510(k)" list:

Screenshot from federalregister.gov.

Screenshot from federalregister.gov.

Devices that stuck out to me are kelly pads, single use acupuncture needles, and operating room lamps!

We talked recently about how tongue depressors are medical devices, and now here's a lamp as a Class II device! It makes sense, though: operating rooms have to be properly lit to be safe. Lights have to avoid casting shadow, shine deeply into cavities, and render light accurately and naturally. They also need to be safely installed to hang over patients and doctors during sensitive procedures and be able to be sterilized. No small feat.

Photo from medwow.com.

Photo from medwow.com.

Single use acupuncture needles are less surprising, as they puncture and enter the body, but I'd bet many people would be surprised to hear that acupuncture uses medical devices. Medical devices are everywhere!

Photo from goacupuncture.com.

Photo from goacupuncture.com.

Kelly pads. These inflatable rubber devices are used on postpartum mothers to monitor blood loss and detect hemorrhage.

Photo from jindalmedical.com.

Photo from jindalmedical.com.

You can check out more Class II devices that are now exempt from premarket notification. How many do you recognize?


Be sure to keep an eye on FDA's news and information releases: it's always good to check in with them and see how they're staying on top of keeping things safe and efficient. You can sign up for their many and varied newsletters here.