A 3D-printed COVID-19 testing swab developed by UCLA Health to help solve the supply shortage was approved by the U.S. Food and Drug Administration, it was announced Friday.
“We now have a secure source to supply all of UCLA Health’s swabs as the need for COVID-19 testing continues to grow,” said Dr. Gabriel Oland, a general surgery resident and UCLA Biodesign fellow who led the effort.
Large quantities of the new swabs can be manufactured rapidly. They are made entirely of plastic from tip to tip, with a lattice design to collect a sample at one end.
“Before the pandemic, we used about 200 nasopharyngeal swabs a day, but now we need 500-600 for COVID-19 testing alone, and we anticipate needing over 1,000 each day in the coming months,” said Omai Garner, director of clinical microbiology testing for UCLA Health.
Several 3D-printed swab prototypes were subjected to rigorous clinical testing on patients with COVID-19, according to the university. The time for development and approval of the most promising design — from Resolution Medical LLC — took just over a month.
Garner and Oland conducted the study with principal investigator Dr. Annabelle de St. Maurice, assistant professor of pediatrics and co-chief infection prevention officer at UCLA Health.
“Although we hoped the Los Angeles area would be spared the brunt of the COVID-19 pandemic, we had to move with urgency to address the testing swab shortage,” de St. Maurice said. “Results of our collaboration mean that UCLA Health is now well-positioned to meet the needs of our community as testing becomes increasingly important.”
Oland has medical and surgical experience — including treating COVID-19-positive patients — as well as an undergraduate degree in biomedical engineering and a familiarity with production methods such as 3D printing. He had been working to develop a non-invasive, intracranial pressure monitoring device before pivoting to the swab task force.
Although the FDA normally requires lengthy and thorough testing and validation of new medical products, swabs fall into a category where the responsibility for validation lies with hospitals and clinical labs.
“It’s not an easy task, but it was imperative that we executed the study right so we could offer the best results for our patients,” Oland said, adding that he has been impressed with the way industry, healthcare systems and regulatory agencies have adapted and worked together to solve this problem under unusually tight time constraints.
>> Want to read more stories like this? Get our Free Daily Newsletters Here!Follow us: