News Feature | July 14, 2015

Medtronic Spends $235M On Detection System That Finds Lost Surgical Items

By Suzanne Hodsden

logozz

Medtronic has announced a $235 million agreement to acquire a California-based start-up, RF Surgical Systems, a medical device company that has developed a system to detect retained surgical items (RSIs) — such as gauze, sponges, or towels — that could be left in the body after surgery. Though these events are relatively rare, spokespeople from both companies said they intend to make prevention, via this system, the “global standard of care.”

Current operating rooms carefully record and count all cotton disposables going into and coming out of the body, but this manual system is subject to human error. If mistakes do occur, the consequences for the patient can include intestinal obstruction, colon perforation, abscess, and infection, which can be fatal.   Even in the best circumstances, the patient would have to undergo an additional surgical procedure to retrieve the item.

A 2015 study that investigated factors contributing to RSIs concluded that longer surgery duration, body mass index, and unexpected events in the operating room all elevate the risk of something being overlooked. Study authors commented, “Despite efforts to minimize the occurrence of RSIs, zero incidence remains elusive.”

To aid in eliminating this sort of surgical error, RF Surgical Systems developed a digital solution by designing the RF Assure Detection System. The system uses tagged cotton disposables that can be detected with a wand using low-frequency, non-ionizing radio waves. If something still is left in the body, it will transmit a signal back to the device, alerting the surgical team.  Not only will they know something is left, they will know exactly where it is.

Since the system was approved in 2006, over 4,500 operating rooms, trauma units, and labor delivery suites have been outfitted with the technology nationwide. Last March, the company unveiled its newest innovation to their technology, the RF Assure Detection System X, which provides a more compliance-driven interface and “real-time” feedback for operating room staff, as well as a more comprehensive scanning component for more complicated procedures.

John T. Buhler, CEO of RF Surgical, noted in a press release that both his company and Medtronic had a long-standing commitment to patient safety. “As we strive to make the RF Surgical technology the global standard of care, we look forward to the innovation opportunity afforded by our combined capabilities,” he said.

“Patients are our priority. Improving patient safety and outcomes is our daily focus, which directly aligns with the RF Surgical technology, a simple and cost-effective solution to avoidable complications in surgical procedures,” said Chris Barry, senior VP at Medtronic and president of its Surgical Innovations business.

Pending regulatory approvals, the deal will be finalized in August 2015. Additional terms of the acquisition were not disclosed.