Featured Product
This Week in Quality Digest Live
FDA Compliance Features
Kari Miller
An effective strategy requires recruiting qualified personnel familiar with the process and technology
Dario Lirio
Modernization is critical to enhance patient experience and boost clinical trial productivity
Alexander Khomich
Healthcare software opens up opportunities for clinics in both management and patient care
Gary Shorter
Pharma needs to adapt and evolve with the changing environment of life science data
Etienne Nichols
Quality management system regulation explained

More Features

FDA Compliance News
Delivers time, cost, and efficiency savings while streamlining compliance activity
First trial module of learning tool focuses on ISO 9001 and is available now
Free education source for global medical device community
Good quality is adding an average of 11 percent to organizations’ revenue growth
Further enhances change management capabilities
Creates adaptive system for managing product development and post-market quality for devices with software elements
VQIP allows for expedited review and importation for approved applicants that demonstrate safe supply chains
An invite from Alcon Laboratories
Intended to harmonize domestic and international requirements

More News

Quality Digest

FDA Compliance

FDA Clears World’s First RFID Surgical Sponge-Counting System

Published: Tuesday, June 26, 2007 - 22:00

(ClearCount Medical Solutions: Pittsburgh) -- The patented SmartSponge System, built by ClearCount Medical Solutions of Pittsburgh and based on radio frequency identification (RFID) has received Food and Drug Administration 510(k) clearance.“We are optimistic the SmartSponge System will address the pervasive problem of retained surgical sponges,” says David Palmer, ClearCount’s president and CEO. “This is the world’s first RFID system that detects and counts surgical sponges and towels during surgical procedures. With an estimated 3,000–5,000 incidents a year, retained surgical sponges are a considerable problem. The SmartSponge System can improve patient safety and efficiency by alerting staff when there is a missing sponge.”

The ClearCount SmartSponge System is a novel, RFID-based solution that was designed after extensive work with nurses and surgeons at leading healthcare institutions. The SmartSponge System uses Texas Instruments Inc.’s Tag-it HF-I portfolio of high-frequency products to automate the process of managing surgical sponges during surgery. The sponges are permanently affixed with passive RFID tags smaller than a dime.

“Unlike other technologies, ClearCount’s RFID-based SmartSponge System allows users to simultaneously count and differentiate between types of sponges,” says Steve Fleck, ClearCount’s cofounder and chief technology officer. “Additionally, since RFID doesn’t require a line of sight between the reader and tags, there is no need to physically separate sponges or orient the tags in any way to scan them. This minimizes the handling of soiled sponges by nursing staff.”

Gautam Gandhi, cofounder and chief marketing officer, says, “A retained sponge incident can lead to serious complications, including sepsis, unnecessary X-rays, need for repeat surgeries, and even death. The economic benefit is clear—the SmartSponge System advances operating room safety and reduces hospital and surgeon liability.”

“The problem of surgical sponges being left behind in various body spaces is something that every surgeon and perioperative care nurse in this country has at least thought about, even if they have not directly experienced the problem,” according to Verna Gibbs M.D., director of the “No Thing Left Behind” initiative, which aims to prevent retained surgical items (www.nothingleftbehind.org). “These events are the product of poor communication and faulty processes of care that cause patient injury. The ClearCount SmartSponge System is an ingenious and simple solution to address both problems in communication and problems in counting practices. This is an exciting new modality which could help surgeons and nurses do a better job in the operating room, and deserves to be evaluated.”

ClearCount Medical Solutions previously supported a study titled “Initial clinical evaluation of a hand-held device for detecting retained surgical gauze sponges using radio frequency identification technology.” The study was published in the medical journal, Archives of Surgery in 2006. Alex Macario, M.D., professor of anesthesia at the Stanford University School of Medicine and lead author of the study, says that although procedures are in place to track objects during surgery, errors do still occur. “This risk significantly increases in emergencies, with unplanned changes in procedure and with patients that have a higher body-mass index,” he says.

Current standard procedures for tracking instruments and sponges involve a baseline count before surgery begins, a second count before the surgeon begins sewing the incision, a third count at wound closure, and a final count before closing the skin. This manual process is time-consuming and subject to human error. At most hospitals, when there’s a discrepancy in the counts, an X-ray is required before leaving the operating room. Additionally, many hospitals call for X-rays for high-risk cases such as emergencies, transplants, and surgeries greater than five hours to assure no retained objects.

ClearCount expects to make available a commercial solution that fully integrates into the current workflow of the operating room by the end of this year.

For more information, visit www.clearcount.com/news/clearcount_fda_approval_press_release1.pdf.


About The Author

Quality Digest’s picture

Quality Digest

For 40 years Quality Digest has been the go-to source for all things quality. Our newsletter, Quality Digest, shares expert commentary and relevant industry resources to assist our readers in their quest for continuous improvement. Our website includes every column and article from the newsletter since May 2009 as well as back issues of Quality Digest magazine to August 1995. We are committed to promoting a view wherein quality is not a niche, but an integral part of every phase of manufacturing and services.