When the first U.S. COVID-19 patient emerged in Washington, UW Medicine, as the state’s foremost provider of advanced medical care, was thrust into the role of trailblazer. Its clinicians and researchers have since mustered a speedy and sometimes ingenious response.

Two examples: Facing a national shortage of diagnostic tests, virologists here developed a novel COVID-19 assay, ensured its accuracy, and earned the Food and Drug Administration’s OK to test patient specimens – all before February had ended. In parallel, clinicians developed a protocol for drive-through COVID-19 screening that shrewdly kept patients isolated in their cars. The site at UW Medical Center-Northwest opened March 6, likely the first of its kind in the nation.

More recently UW Medicine was contacted by a local craftsman whose idea and sense of urgency perfectly matched the health system’s needs and the UW’s innovative spirit. It also gave rise to a speedy cross-campus collaboration.

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Over the drone of 3D-printers at his Redmond studio, Tim Prestero explained his impetus to offer help pro bono: “It’s amazing what you can accomplish if you don’t care who gets the credit,” he said, paraphrasing Harry Truman. “We’re a nonprofit; this is what we do,” he said, describing his company, Design That Matters.

On March 19, Prestero 3D-printed horseshoe-shaped strips of plastic as the “cradle” of a face shield to protect front-line caregivers from COVID-19. The next day the three-piece prototype — cradle, transparent shield, and elastic band — were with UW Medicine stakeholders.

“Tim wanted to make something happen quickly,” said Vanessa Makerewicz, infection-control manager at Harborview Medical Center. “He had dropped samples off with our supply chain Friday and I saw them that night. Sunday, I brought them into the hospital for the nurses to see. We gave Tim feedback that the face shield had too much of an opening along the forehead.”

Prestero returned two days later with an updated version that sported a visor. It was perfect. Another cool feature: the cradle’s three protruding prongs accept 8.5×11-inch transparencies like those found at office supply stores. These transparencies become face shields with enough vertical cover that, when properly disinfected, allow nurses to wear the fabric masks that cover their mouth and nose for a whole day instead of just one patient visit.

The face shield’s next stop was with Dr. Rob Sweet, chief of health care simulation sciences. He chairs an innovations committee that needed to choose one project among several prospects to rapidly manufacture.

“It was an easy choice,” Sweet said. “This design was so simple, and it already had undergone preliminary testing at Harborview.”

Soon after, Sweet’s CREST lab and several other UW 3D-printing sites were making and assembling Prestero’s face shield.

Sweet also engaged Dmitry Levin and Dr. Beth Ripley to expedite the device’s regulatory approval. Levin, who runs a 3D-printing lab in the Heart Institute, ensured that the face shield could handle routine use and offer adequate splash protection. He wrote documentation required for submission to the National Institutes of Health (NIH).

The NIH sent the design to the Veterans Healthcare Administration (VHA), where Ripley kept the project moving apace. She’s a UW radiologist who sees patients at the VA Puget Sound and also chairs the VHA’s advisory panel on 3D printing. She oversaw clinical review of the face shield, which became one of the projects evaluated on a fast track.

With the VA Puget Sound’s stamp of approval, the , freely sharing its specifications with organizations worldwide. This happened on March 28, just eight days after UW stakeholders saw the first prototype. The design page’s sudden popularity initially crashed the NIH 3D-printing site’s servers, Prestero said with a laugh.

The face shield’s journey was on the radar of Colleen Carroll, maker in residence at the Paul G. Allen School of Computer Science & Engineering and associate director of the Center for Digital Fabrication (DFab). She joined others across UW’s three campuses reaching out through DFab’s network of digital fabrication researchers, staff, and students.

“The main thing that’s been so cool for me is how truly cross-university it’s been,” Carroll said. “We’ve pulled the entire campus together in a way I’ve never seen before. And it happened so fast.”

Jumping into action and harnessing all 37 3D printers in UW HFS Makerspaces, program manager Derrick Van Kirk says he’s found reward in helping the relief effort. Three undergraduates and a graduate student have helped manage the production line, and the labs have been coordinating with each other to maximize output.

Wherever 3D printers exist on campus — be it UW Tacoma, UW Bothell, the Global Innovation Exchange, and more — the machines all have been printing the face shield design. More than 70 printers have produced more than 1,000 cradles, Carroll said. Given that each cradle takes 3.5 hours to create — adding thin layer of plastic with each pass of the printer head – the time investment has been enormous.

“It’s been the most gratifying two weeks of my professional work life,” Van Kirk said. “We have to get it done. It’s been a lot of hard work, but super gratifying.”

Today, UW Medicine front-line clinicians are wearing the face shields.

“People at the hospital are very excited about it,” said Harborview Emergency Department nurse Amy Leah Potter. “We can wipe them clean and let them dry, same as with our normal PPE, but we can also change [the transparencies] out if they get scratched or damaged, so it’s a lot more reusable.  It’s incredibly impressive that somebody came up with this to allow us to do our jobs better.”

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The finding that early brain chemical alterations tend to normalize during the course of development in children with autism spectrum disorder gives new insight to efforts to improve early detection and intervention. The findings were reported July 31 in the 

“In autism, we found a pattern of early chemical alterations at the cellular level that over time resolved – a pattern similar to what others have seen with people who have had a closed head injury and then got better,” said Stephen R. Dager, a UW professor of radiology and adjunct professor of bioengineering and associate director of UW’s Center on Human Development and Disability.

Neva Corrigan, a senior research fellow in radiology, was first author and Dager corresponding author of the study, titled “Atypical Developmental Patterns of Brain Chemistry in Children with Autism Spectrum Disorder.”

“The brain developmental abnormalities we observed in the children with autism are dynamic, not static. These early chemical alterations may hold clues as to specific processes at play in the disorder and, even more exciting, these changes may hold clues to reversing these processes,” Dager said.

In the study, scientists compared brain chemistry among three groups of children: those with a diagnosis of autism spectrum disorder, those with a diagnosis of developmental delay and those considered typically developing. The researchers used magnetic resonance spectroscopic imaging, a type of MRI, to measure tissue-based chemicals in three age groups: 3 to 4 years old, 6 to 7 years and 9 to 10 years.

One of the chemicals measured, N-acetylaspartate, is thought to play an important role in regulating synaptic connections and myelination. Its levels are decreased in people with conditions such as Alzheimer’s, traumatic brain injury or stroke. Other chemicals examined in the study – choline, creatine, glutamine/glutamate and myo-inositol – help characterize brain tissue integrity and bioenergetic status.

A notable finding concerned changes in gray matter N-acetylaspartate concentration: In scans of the 3-to 4-year-olds, concentrations were low in both the autism spectrum disorder and developmentally delayed groups. By 9 to 10 years, N-acetylaspartate levels in the children with autism spectrum disorder had caught up to the levels of the typically developing group, while low levels of N-acetylaspartate persisted in the developmentally delayed group.

“A substantial number of kids with early, severe autism symptoms make tremendous improvements. We’re only measuring part of the iceberg, but this is a glimmer that we might be able to find a more specific period of vulnerability that we can measure and learn how to do something more proactively,” said Annette Estes, a co-author of the study and director of the UW Autism Center. She is an associate professor of speech and hearing sciences.

Study co-author Dennis Shaw, a UW professor of radiology and director of MRI at Seattle Children’s, observed that the findings “parallel some of the early brain structural differences we and others have found on MRI that also appear to normalize over time in children with autism. These chemical findings will help to better establish the timing and mechanisms underlying genetic abnormalities known to be involved in at least some cases of autism.”

Dager and UW colleagues are currently using more advanced MRI methods to study infants at risk for autism spectrum disorder because of an older sibling with autism.

“We’re looking prospectively at these children starting at 6 months to determine if we can detect very early alterations in brain cell signaling or related cellular disruption that may precede early, subtle clinical symptoms of ASD.”

Despite the encouraging finding, science has yet to pinpoint the when, what and why of autism’s inception, an event often likened to the flipping of a switch. Discovering the earliest period that a child’s brain starts to develop a profile of autism spectrum disorder is crucial because, as the study acknowledged, “even a relatively brief period of abnormal signaling between glial cells and neurons during early development would likely have a lasting effect” on how a child’s brain network develops.

This study also suggests that developmental delay and autism spectrum disorder are distinct disorders having different underlying brain mechanisms and treatment considerations, Dager said.

“Autism appears to have a different pathophysiology and different early biological course than idiopathic developmental disorder. There are differences in their underlying biological processes; this supports the notion that ASD is different from developmental delay and challenges the notion that the increasing prevalence of autism merely reflects a re-categorization of symptoms between autism and intellectual disabilities.”

The study was conducted by scientists from UW’s departments of Radiology, Speech and Hearing Sciences, Psychiatry and Behavioral Sciences, Anesthesiology and Bioengineering; the Department of Radiology at Seattle Children’s; the Department of Psychiatry at the University of North Carolina, Chapel Hill; and the Autism Speaks organization in New York City.

This study was supported by National Institutes of Health grants 2P01 HD 35465, 1P50 HD 55782, and 1R01 HD 065283.

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Harborview Medical Center, UW Medical Center, Northwest Hospital & Medical Center, Valley Medical Center and Seattle Cancer Care Alliance each met criteria for inclusion in the 2013 , a nationwide analysis. Seattle Cancer Care Alliance is a consortium comprising UW Medicine, Fred Hutchinson Cancer Research Center and Seattle Children’s.

“Our hospitals take pride in creating a welcoming environment and providing inclusive care to all patients and families,” said Johnese Spisso, chief health system officer, UW Medicine, and UW vice president for medical affairs. “We are proud to demonstrate UW Medicine’s commitment to equal access for lesbian, gay, bisexual and transgendered community members.”

This year, 464 facilities nationwide, nearly double last year’s total of 234, met the Human Rights Campaign Foundation’s survey criteria in four core areas of policy and training:

• Equal patient access to care
• Equal visitation access for same-sex partners and parents
• Equal access to employment
• Completion of lesbian, gay, bisexual and transgender health education by key hospital staff

“These kinds of indices are useful in that they allow you to see the standard of care in our country, so you can meet or exceed it,” said Dr. Shilpen Patel, a UW Medicine radiation oncologist and secretary to the board of the National Gay and Lesbian Task Force Foundation. He also just finished a six-year term on the board of Equal Rights Washington.

“I’m a cancer doctor,” he said. “It’s very difficult for patients to get through care without their support network. Families in the LGBT community come in different shapes, and when patients aren’t afraid to bring in their spouse or partner or their kids, it’s a healthier experience for everyone. This is us delivering the patient-centered care that we talk about.”

The UW Medicine clinicians who developed the implantable device hope that success in a 10-person surgical trial of Meniere’s patients will lead to exploration of its usefulness against other common balance disorders that torment millions of people worldwide.

The device being tested — a cochlear implant and processor with re-engineered software and electrode arrays — represents four-plus years of work by Drs. Jay T. Rubinstein and James O. Phillips of UW’s Department of Otolaryngology-Head and Neck Surgery. They worked with Drs. Steven Bierer, Albert Fuchs, Chris Kaneko, Leo Ling and Kaibao Nie, UW specialists in signal processing, brainstem physiology and vestibular neural coding. Rubinstein is also a UW professor of bioengineering.

“What we’re proposing here is a potentially safer and more effective therapy than exists now,” said Rubinstein, an ear surgeon and auditory scientist who has earned a doctoral degree in bioengineering and who holds multiple U.S. patents.

In the United States, Meniere’s affects less than 1 percent of the population. The disease occurs mostly in people between ages 30 and 50, but can strike anyone. Patients more often experience the condition in one ear; about 30 percent of cases are bilateral.

The disease affects hearing and balance with varying intensity and frequency but can be extremely debilitating. Its episodic attacks are thought to stem from the rupture of an inner-ear membrane. Endolymphatic fluid leaks out of the vestibular system, causing havoc to the brain’s perception of balance.

Many patients respond to first-line treatments of medication and changes to diet and activity. When those therapies fail to reduce the rate of attacks, surgery is often an effective option but it typically is ablative (destructive) in nature. In essence, the patient sacrifices function in the affected ear to halt the vertigo — akin to a pilot who shuts down an erratic engine during flight. Forever after, the person’s balance and, often, hearing are based on one ear’s function.

With their device, Phillips and Rubinstein aim to restore the patient’s balance during attacks while leaving natural hearing and residual balance function intact.

A patient wears a processor behind the affected ear and activates it as an attack starts. The processor wirelessly signals the device, which is implanted almost directly underneath in a small well created in the temporal bone. The device in turn transmits electrical impulses through three electrodes inserted into the canals of the inner ear’s bony labyrinth.

“It’s an override,” Phillips said. “It doesn’t change what’s happening in the ear, but it eliminates the symptoms while replacing the function of that ear until it recovers.”

The specific placement of the electrodes in the bony labyrinth is determined by neuronal signal testing at the time of implant. The superior semicircular canal, lateral semicircular canal and posterior semicircular canal each receive one electrode array.

A National Institutes of Health grant funded the development of the device and its initial testing at the Washington National Primate Research Center. The promising results from those tests led the U.S. Food and Drug Administration, in June, to approve the device and the proposed surgical implantation procedure. Shortly thereafter, the limited surgical trial in humans won approval from the Western Institutional Review Board, an independent body charged with protecting the safety of research subjects.

“If you started from scratch, in a circumstance like this where no one has ever treated a vestibular disorder with a device, it probably would take 10 years to develop such a device,” Rubinstein said.

The device epitomizes the translational advancements pursued at UW’s academic medical centers, he said. He credited the team’s skills and its access to the primate center, whose labs facilitated the quick turnaround of results that helped win the FDA’s support.

A successful human trial could lead the implant to become the first-choice surgical intervention for Meniere’s patients, Phillips said, and spark collaboration with other researchers who are studying more widespread balance disorders.

The first patient will be a 56-year-old man from Yakima, Wash. He has unilateral Meniere’s disease and has been a patient of Rubinstein’s for about two years.

Cochlear Ltd. of Lane Cove, Australia, will manufacture the device. Cochlear is a medical equipment company and longtime maker of devices for hearing-impaired people.