By Beth Bacheldor
March 5, 2008—Almost a year after purchasing
SurgiChip, an
RFID system designed to prevent surgical errors, mobile solutions provider
InfoLogix is launching a new version of the system. The solution consists of a disposable label embedded with a passive 13.56 MHz
RFID tag that complies with the
ISO 15693 standard, an RFID label
printer, a handheld RFID
interrogator that can transmit data via a wireless local area network, and Web-based software that hospital staff members can use to view and analyze tag reads collected, as well as the patient data associated with those tags.
Hospitals can use SurgiChip to automate the documentation of surgery, thus ensuring that the proper procedure is performed on the right patient—a process typically handled with a simple felt-tip pen. "Currently, today, what they do for the surgery is they circle the area with a purple marker and the physician actually signs his name on the patient's body when the surgery is complete," says David Gulian, president and CEO of InfoLogix.
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SurgiChip aims to eliminate errors caused by using markers for the documentation of surgery.
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Not surprising, Gulian says, using the marker can lead to mistakes. In Pennsylvania, he notes, more than 170 "wrong site" surgical errors and 250 "close calls" were documented over a 30-month period. According to InfoLogix, a patient in New York who had surgery on the incorrect knee recently received a $450,000 settlement from the hospital that committed the error. And in Rhode Island, another hospital was fined $50,000 for a wrong-site surgery.
SurgiChip aims to eliminate such errors. The 2-inch by 2-inch RFID-enabled adhesive label is encoded and printed with a unique ID number, a patient's name and surgical procedure, and any other information deemed necessary. All of this information is encrypted (the advanced
encryption algorithms secure the patient data at all times, InfoLogix says, making the system HIPAA-compliant) and can also be stored on a back-end database that the company maintains at its headquarters in Hatboro, Penn.
The label is applied to the site on the patient where the surgery is slated to occur. During a pre-operative workup, nurses and anesthesiologists can employ the RFID interrogator to encode information on the
tag, thus documenting that they've seen the patient. Similarly, the surgeon can record the procedure's start and completion. "This closes the loop of verification," says Gulian. All the RFID data can be accessed via a Web-based application that connects, via the Internet, to servers at InfoLogix's headquarters.
In a pilot program launched in 2004, the
Palm Beach Orthopedic Institution began using the system for its surgical procedures. In November 2004, the
U.S. Food and Drug Administration (FDA) cleared the device for marketing based on a review of safety, effectiveness and software validation information submitted by SurgiChip.