KALAMAZOO — Stryker Corp. is so confident about the efficacy and reliability of a new surgical safety device that it’s willing to issue a guarantee to hospitals that use it.
The company’s new SurgiCount safety system counts sponges used in surgical procedures, reducing the chances of one getting left inside of a patient. If a hospital incurs a liability from a failure of the system, the Kalamazoo-based manufacturer of implants, surgical equipment and other devices will pay up to $5 million, plus refund the purchase price.
The guarantee Stryker implemented this month sheds light on a persistent but preventable safety problem in health care. The company cites research that found there are 4,000 incidents annually in the U.S. where surgical sponges are left inside a patient.
Those incidents not only create needless pain and suffering for patients, but also add an average annual cost of $2.4 billion to the health care system in liability payouts.
As a leading medical device manufacturer, Stryker hears the calls from clients for technology focused on generating greater patient safety, said Nate Miersma, director of the surgical, safety and efficiency business unit at Stryker.
“It’s a pretty loud voice in our customer base,” Miersma said. “These (incidents) are completely preventable.”
Developed by Irvine, Calif.-based Patient Safety Technologies Inc., a company Stryker acquired two years ago for $120 million, SurgiCount is used at more than 480 hospitals nationwide, including at the Mayo Clinic and Cleveland Clinic. Of nearly 170 million SurgiCount Safety Sponges used in more than 9 million procedures over five years, the system has yet to fail to identify a retained sponge, Stryker said.
Given that track record, Stryker is confident that it may never actually have to pay the guarantee.
“We believe so strongly in this technology and its capabilities and its history of success, with no history of retained surgical sponges after the technology has been put in place, that we feel comfortable putting our money where our mouth is and ultimately put the SurgiCount promise out there for customers to take advantage of,” Miersma said.
The SurgiCount system offers hospitals a technology to replace the manual process of counting surgical sponges and tracking them with a white board. Complicated surgical procedures can easily use hundreds of sponges, but some sponges occasionally get missed in the count amid all of the activity in an operating room. It’s a reflection of the human element of the surgical team that happens despite the training, capability and commitment to patient safety, Miersma said.
“As you can imagine, when humans are doing that (counting sponges manually) at the same time the surgical procedure is going on, at the same time the electronic medical record needs to be updated in the back of the room, and as an anesthesiologist is asking for some additional medications for the patient, humans are prone to error,” he said. “And that’s why in a lot of other industries outside of health care, folks have gone to technologies that help reduce these errors.”
SurgiCount scans a code on each package of sponges when they’re opened. Individual sponges have their own serial number and are scanned as well by a device before use. The scanner tracks the exact number of sponges used in the procedure. At the end of the procedure, each sponge is scanned out and the system reconciles the count.
The information from the procedure is then uploaded into a database at the hospital for archiving if a question ever arises.
While he’s unsure whether the indemnity and money-back guarantee — which is contingent on a hospital using the system properly and in all of its operating rooms — will directly push sales of the SurgiCount system, it surely “opens up the conversation a little bit more easily,” Miersma said.