Alum’s All-in-One Filter Needle Device Receives FDA Approval

Sue Carr, RPh, created a first-of-its-kind device to make withdrawing medication from ampoules safer for healthcare providers and patients.

The Food and Drug Administration (FDA) has approved the first all-in-one filter needle to remove shards of glass from medications stored in ampoules. The FROG® (Filter Removal of Glass) was created by Massachusetts College of Pharmacy and Health Sciences (MCPHS) alum Sue Carr, RPh, BSP ’84.

This regulatory milestone is “a win for every healthcare worker who’s ever struggled with cumbersome drug prep protocols and every patient who deserves safer medication handling,” Carr said in a press release.

According to the release, receiving this approval is a rigorous process as a company must prove the product is “substantially equivalent” in safety and effectiveness to a legally marketed device.

“This approval allows us to take the next step in our mission to revolutionize medication safety," she said.

Carr was first inspired to develop a better way to handle medications from ampoules while she was an MCPHS student, working in the pharmacy at Faulkner Hospital and preparing large batches of IV bags. The multi-step process involves using a filter needle to withdraw the medicine, capping it, replacing the needle, and then injecting the medication into an IV bag or directly into a patient.

“It was tedious switching so many needles, and I kept sticking myself,” Carr recalled during an interview while she was preparing to submit FROG for FDA approval. “I went to my director and told him there had to be a better way. He told me if I could come up with one, I’d be a millionaire. It’s never been about money, but I never forgot that.”

Carr worked as a retail and hospital pharmacist, where she continued to see safety issues with filter needles. She developed, prototyped, and patented the FROG, then founded CarrTech Corp. and jumped into full-time entrepreneurship.

With FDA approval, Carr and her company are working to scale-up manufacturing and distribution of FROG not just in the U.S., but around the world.

“If I can save just one life, then my journey has been worth it,” she said.