Anna K. Young
CEO, Co-Founder

Medical Device Archeologist, TEDMED Speaker, Fast Company Most Creative Business People, MIT Lecturer.

 

Clinician Spotlight: Brittany and her Infant Earmuffs

A peace dividend of the war against COVID-19 has undoubtedly been mainstreaming the notion of a MakerNurse in every hospital around the world that’s at war with the virus. While history brought us to this moment, the nurses rising to the challenge didn’t spontaneously become tinkerers. At MakerHealth, it is our mission to bring prototyping tools to these nurses to accelerate their ideas and to put a spotlight on their work.

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As Brittany Hruska steps out of the helicopter ambulance, the twin engine’s noise approaches 90 decibels. The crew is busy securing the aircraft and updating the patient transfer team on the ground at UnityPoint Health – Blank Children’s Hospital in Des Moines. There’s precious cargo on board and Brittany is laser-focused on the baby’s condition. There are portable patient monitors to attend to. An IV drip hand-off is done in seconds. A ventilator to manage. Multi-million dollars worth of transport equipment is used to take the patient to another million dollar ICU setting where doctors and nurses are waiting to help.

Instead of a tiny gurney, the patient is safely transported inside an isolette that acts as a portable NICU with all of the monitors, sensors, oxygen, and IV pumps needed to keep the infant safe during the flight. Inside, a pair of half-spheres covered by a cloth headband is wrapped snugly around the baby’s head. These devices mean the difference between the patient sleeping or feeling like they are in the middle of a tornado surrounded by pervasive alarms. These noise-dampening earmuffs are a nurse-made device, called Comfies, created by Brittany Hruska, BSN, RNC-NIC with tools from the MakerHealth in the Cloud program. Brittany has been a neonatal intensive care (NICU) nurse for 17 years and for the past 6 years she has also been a part of the air ambulance transport team.

The babies that arrive in the NICU are there because they were born prematurely or require constant monitoring and care for conditions such as sepsis, respiratory distress and birth abnormalities. And while overall NICU quality improvement scores have increased over the last few years, there’s still the nagging problem of noise. The decibel level doesn’t get any better as the patient trades the tornado-esque helicopter for the aggregate of alarms, intercoms, doors, and people talking.

“When you are in the NICU, keeping infants in a quiet environment can be the difference between thriving or having adverse effects—cochlear damage, brain damage, developmental delays, disruption of growth, or a decline in physiologic stability,” says Brittany.

Noise levels of pumps, ventilators, and alarms can often reach 70-80 + decibels (think loud woodshop vacuum cleaner), far above the American Academy of Pediatrics recommended maximum noise level of 45 decibels (D’Souzal, 2017). For Brittany, seeing these tiny patients, already in a fragile situation, have to endure this nonstop was unbearable.

“Any bedside NICU nurse can tell you that a noise sensitive baby will drop their oxygen saturation with something as simple as talking. We have signs scattered throughout our NICU to ‘keep quiet’, but that only helps so much.”

Brittany was not going to simply make a better “Quiet Please” bulletin board sign. Two years ago, she began an experiment to create a more peaceful, healing environment for the babies.

In the same way that the helicopter crew uses noise-reducing headsets for protection, she found products on the market that could be used for neonatal patients. But when she tried them, they only reduced the noise by about 7 decibels at $18 a pair. She felt she could do better.

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Brittany is a MakerNurse. She makes infant positioners with rolled blankets, CPAP cushions cut from duoderm, and stabilizers for high frequency oscillatory ventilation using tape and blankets. She cooks her own carnitas. For Halloween, while the rest of us buy our kids Target costumes, Brittany handmade costumes for weeks-old NICU babies to dress them up as superheroes ranging from Batman to Wonder Woman. It’s now a yearly hospital tradition.

So what does a helicopter-flying-costume-designer-critical-care nurse do about noise-dampening wearables for babies? She makes them.

Getting Started with Experiments

From the start, Brittany felt the materials she chose would be the most important factor for noise dampening. A little research led her to gel memory foam, the material in bike seats and some mattresses, as the core construction material for her earmuffs. She tested the gel for sound pressure and realized she needed an external layer to bounce the initial sound waves off the device.

More material experimenting led her to Flex Seal® brushable rubber and Mepilex®, a Swedish skin safe foam used in wound care. Stacking all three layers—the gel foam, brushed over with rubber, and sealed with Mepilex® created the “Earmuff Prototype 1.” The layers were hand-cut and shaped into a half-spheres to fit the infant’s head with the skin safe foam providing contact protection. The whole device was secured with a stretchy headband to keep them in place and seal the tiny baby ears—no adhesives or sticky tape required.

Early testing was overwhelmingly positive.

“I still remember some of the first earmuffs that I made and the audiologist getting so excited seeing the noise reduced by 20-30 decibels – that’s the equivalent of going from a vacuum cleaner noise to the hum of a refrigerator.” 

“It brings noise to a safe level, even similar to that of a womb. I went to show my coworkers the data right away. I knew we were on the right path with the materials and design,” recalls Hruska.

She was looking forward to integrating the DIY earmuffs into the patient care process, but she was also cautiously optimistic. The noise reduction data looked great, but making each earmuff was intense and took days of work. It was like making a tennis ball by hand. First, the cup-shaped core needed to be cut and shaped by hand from a sheet of gel memory foam.

Next, the core was coated with the Flex Seal®, a messy process that required 30 minutes to apply the rubber and then a few days to allow for drying and smoothing. Once dry, the Mepilex® was cut to size and applied to the patient-facing rim of the muff. Finally, the headband was cut and sewn from fabric. A single set of earmuffs could take up to 3 days to make. Meeting the demand for 40-50 ear muffs per month was just not feasible.

The experiment was great. The data looked promising. And a protocol for creating a solution had been experienced. The NICU team needed another leap for Brittany’s earmuffs to make a difference.

Building a Prototyping Literacy with MakerHealth Tools

Around this time, Denise Cundy, Assistant VP of Nursing and Alisha Tompkins, a Medical Surgical Nurse and fellow MakerNurse Champion of UnityPoint Health – Des Moines, had just subscribed UnityPoint Health – Iowa Methodist Medical Center and Blank Children’s Hospital to the Makerspace in the Cloud program . The program connects point-of-care clinicians with curated prototyping resources and real-time video support to build and iterate medical device ideas.

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It was a bit by chance that I learned about Brittany’s efforts to create these ear muffs at the same time we were exploring a relationship with MakerHealth. Her tenacity in creating an effective design for her ear muffs was admirable to me and we were excited to be able to provide additional resources to her in order to accelerate her work.

-Denise Cundy, Assistant VP of Nursing

Launching Comfies on Create

Last summer, Brittany launched her Comfies fabrication project in our MakerHealth portal on the cloud called Create. She uploaded information related to her experiments, technology readiness levels, personal fabrication experience, and level of experimentation scores which was then fed into our prototyping algorithms. This generated a prototyping genome picture of her project—a snapshot of fabrication and material possibilities to accelerate her idea and the technical training required that our team was ready to help her with.

Soon after, Brittany appeared on a video call screen with her earmuffs at MakerHealth HQ in Boston. On the table was the challenge of how to go from making a single set of earmuffs in days to something that could get to many patients affordably and timely. This wasn’t going to work simply by 3-D printing the design and letting the machines do the fabrication. Comfies’ prototyping genome requires material integrity because of the specific soundproofing feature and skin-safe properties Brittany had designed. Going through the prototyping genome allowed Brittany and the MakerHealth team to map a series of experiments to speed up earmuff fabrication and retain the properties that gave her such great performance data to begin with.

After the first video call session, Brittany received her first MakerHealth experiment kit in the mail. It included an array of materials, hand tools, and on-demand instructions that streamlined the steps to iterate on her design. She learned Autodesk Fusion 360 to create a two-part mold using MakerHealth Create. This let her access our remote digital fabrication services to 3-D print the mold parts that were then mailed to her in an experimentation kit. She filled each mold with pourable foam to generate a cast part of her earmuff core. It took about 10 minutes.

What had taken her a day to create one device was now a batch process of 10 minutes. The cloud system made multiple copies of each mold, which allowed her to make more than one earmuff at a time. She tweaked the designs to generate 3-D printed molds of different sizes for different patients. By printing an array, she could manufacture multiple sets of earmuffs at a time. The cloud machines do their job, the algorithms help with the selection of the materials, and then Brittany adds finishing touches to the whole operation.

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By printing multiple molds, Brittany is now able to manufacture multiple sets of earmuffs at a time, reducing the time required to make a completed set from over 90 minutes to 10 minutes.

From Cloud Prototype to Patient Care on the Unit

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The results of the early fabrication experiments with the Makerspace in the Cloud program have streamlined production. With a reliable pipeline of earmuff units being produced, UnityPoint Health – Blank Children’s Hospital has launched an efficacy study with their Audiology Department to measure how well the Comfies’ noise reduction properties affect patient care. Early results of testing with patients have been incredibly promising.

During a routine neonatal MRI, she tested the earmuffs on an infant who slept for 2-hours during the procedure. “It was emotional to see my first patient sleep peacefully for multiple hours with the earmuffs on, not require any sedation for an MRI, and to have perfectly intact skin after everything,” Brittany recalled.

In between testing with outpatient audiology subjects and working in the NICU, she’s been brainstorming other scenarios where infant patients could benefit from noise-free environments including drug withdrawal babies in the NICU.

When asked, “What’s next?” Brittany stated,

“I’m thrilled to have come this far in my maker journey, and it’s like I’m just getting started as a health maker.”

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Catching up with her since the COVID-19 crisis arrived, she has been uploading some new projects to Create to generate more experiments specific to fighting the virus such as ear savers, protective covers for telemedicine carts in the hospital, face shields, and a specially designed surgical caps to hold long hair. Experiments like these can help tackle healthcare’s biggest challenges across the entire continuum of care. We need experimentalists and maker nurses like Brittany to keep discovering and acting on them. During these uncertain times, it gives us hope that the frontlines have nurses like Brittany on their team.

Tens of thousands of babies across the country could benefit from Comfies during air transport, MRI scans and NICU stays for extreme prematurity, drug withdrawal or other critical conditions. Help Brittany reach these infants by registering to receive Comfies updates to be released post-study.

Photos courtesy of UnityPoint Health; Brittany Hruska 

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