By David Wyld, Contributing Editor
In late 2002, a Canadian woman set off an airport metal detector. When she was “wanded,” the metal detector consistently sounded when placed near her abdomen. She had undergone surgery four months earlier and had suffered from unexplained abdominal pain ever since. Several days after the airport incident, an x-ray of her abdomen revealed the presence of a 12-inch long, 2-inch wide surgical retractor.
According to the most recent comprehensive study on the incidence of such surgical errors, 2,710 foreign objects were left in American patients in the year 2000. This translates into an incidence of .008% of all surgeries in the U.S., meaning that one has approximately a 1 in 10,000 chance of having something unintentionally left inside of them after surgery.
Recent research on the subject, published in the New England Journal of Medicine, indicates that two-thirds of all retained objects are surgical sponges. The risk of foreign object retention has been found to be greatest in instances of emergency surgeries and in patients with high body mass indexes. Though the actual instances are fortunately rare (far less common than the “urban legends” of surgeons leaving their wristwatches in patients’ bellies or the infamous “Junior Mint” episode of Seinfeld where a candy landed inside a surgical patient), medical literature is replete with cases of sponges and other items being left inside patients during surgery. Retained sponges and surgical instruments have remained undetected for surprisingly long periods of time, though not necessarily without causing symptoms.
The retained sponge problem
The medical term for a “retained sponge” is gossypiboma (derived from the Latin gossypium, for “cotton” and the Swahili boma, for place of concealment). Gossypiboma is regarded as an all-encompassing term in the medical literature, as it now includes all types of foreign articles that can be inadvertently left in a patient’s body during surgery, including not just sponges, but also:
- surgical instruments
- knife blades
- safety pins
- electrosurgical adapters.
Sponges are thus the main focus of concern, due to their omnipresent use in even the simplest of surgical procedures, including laproscopic work. Sponges are used to soak-up blood but also to enable surgeons to get a better grip on instruments, tissue, and even organs. They are also of paramount concern because when left in the body, a simple, porous sponge can cause both immediate and/or long-term health effects, ranging from minor inflammatory effects to fistulas, adhesions, and even sepsis. The sponges can calcify and be mistaken later in X-ray and MRI scans as possible tumors, leading to costly and unnecessary treatments, not to mention stress on unsuspecting patients and their families.
In 2007, the standard medical protocol is for multiple members of the surgical team to perform multiple manual counts of sponges and medical instruments before, during and after surgery, hoping that the numbers match at all times. Obviously, in the frenetic environment of the operating room, such a manual-based process is vulnerable to human error. In fact, research from the U.S. Agency for Healthcare Research and Quality has shown that when sponges have been left behind, the manual count in the operating room has been shown to be falsely correct in more than three quarters of non-vaginal surgeries. If the manual counts do not sync, nurses must try to solve the mystery by taking on the messy task of sorting through blood-soaked sponges and gauze.
If the count is still deemed unreliable, surgical patients are then routinely subjected to X-rays to attempt to double-check that all sponges have indeed been removed – a step that adds cost and time to the surgical process and is not 100% accurate. For example, a sponge remaining behind a bone will not show-up on an X-ray. Even so, in high-risk or long-duration surgeries, patients are now routinely X-rayed to detect sponges. Dr. Jeffery Port, Chairman of RF Surgical and a thoracic surgeon at Weill-Cornell Medical Center in New York City commented that: “Although nurses do a good job keeping track of sponges, gauze and instruments in the operating room, there are several patients who retain objects in their body. The fear that we’re going to leave something behind also creates chaos when manually counting equipment after the operation.”
In a 2003 commentary for the Agency for Healthcare Research and Quality by Dr. Verna C. Gibbs, MD, in the University of California, San Francisco’s Department of Surgery, commented that: “The critical question is not, ‘Was the count correct?’ It is, ‘Is there a sponge or instrument in the patient?’ Unfortunately, we have yet to identify the best way to answer this question.”
The RFID solution for the operating room
Current research has indicated that RFID may give a valuable solution to the problem. There are several companies vying to create “smart sponge” systems for the operating room. These include RF Surgical Systems of Bellevue, Washington, and ClearCount of Pittsburgh, Pennsylvania. RF Surgical Systems’ RF-Detect system was the brainchild of Dr. Jeffery Port and William Blair, an electrical engineer, who first envisioned the concept a decade ago. ClearCount was founded by Gautam Gandhi and Steve Fleck, who came up with the idea for RFID-tagged surgical sponges while students at Carnegie-Mellon University. Both companies are vying for what promises to be one of the most lucrative in-hospital markets for RFID, as sponges are both plentiful and disposable in today’s operating rooms. RF Surgical’s RF-Detect sponge detection system received FDA regulatory approval for patient use in November 2006, and approval for ClearCount’s SmartSponge system is anticipated in 2007. Both systems embed surgical sponges with small RFID tags, programmed with a unique serial number that allows the reader to report any sponges that may be present in the body cavity.
A recent test validating the capabilities of RFID-equipped sponges was published last year in the prestigious medical journal, the Archives of Surgery. The study was conducted by the Stanford University School of Medicine and funded by grants from the National Institutes of Health and the Small Business Innovation Research Program. The subjects in this study were eight patients undergoing abdominal or pelvic surgery. Just before closing the incision, the surgeon placed an RFID-tagged sponge (containing a 20mm diameter RFID tag) in the body cavity. Then, the sides of the incision were pulled together to temporarily “close” the wound.
A second surgeon was then called in, who had not witnessed the first surgeon insert the RFID sponges. He then used a wand-style RFID reader and passed it over the incision site in order to attempt to locate the RFID sponges. In all eight cases, the RFID sponges were accurately located in less than 3 seconds, with no false positive or negative readings found in using 28 tagged sponges. Dr. Alex Macario, the lead researcher of the Stanford study, believes that such RFID-based tracking systems will become commonplace, observing that: “We need a system that is really fail-safe, where, regardless of how people use counting-system technology, the patient doesn’t leave the operating room with a retained foreign body.”
There are a multitude of practical considerations when introducing new procedures and new equipment in the surgical theater. First, there is an issue of space, as introducing new equipment into the already cramped, frenetic environs of the surgical theater is an issue, regardless of how small the form factor of the readers may be. Also, there may need to be some ergonomic and operational changes made in the operating room, as RFID readers may detect not only the targeted sponges in the patient, but any stored for use around the patient. The nature of surgery also presents unique considerations, but tags have already been developed that can withstand the temperatures required for sterilization.
Can RFID tag every item in the surgical theater? ClearCount’s Gandhi reports that more work needs to be done in tagging steel surgical tools, due to the metal and form factors involved.
There is also the cost issue. Harrison Chow, a clinical instructor and perioperative management fellow in Stanford University Medical Center’s Department of Anesthesia, recently conducted an independent economic analysis on the cost/benefit of RFID-tagging of surgical sponges. He concluded that this technology “appear(s) to be economically attractive from society’s perspective, as long as this new technology approximately cuts in half the time nurses spend counting sponges.”
The final “elephant in the room” may be the liability issues involved for the manufacturers of all such RFID-devices for the surgical theater, as they could readily be the subject of malpractice claims if their devices fail to correctly detect the presence of surgical sponges or other foreign bodies.
The hospital environment may be one of the true hotbeds for RFID activity in the coming years. In fact, analysts have projected that the market for RFID and related technologies will grow to over $8.8 billion by 2010. This is in spite of the fact that health care administrators in the U.S. are notoriously slow to adopt new technologies. RFID presents compelling benefits across several areas, beyond the operating room, including:
- Patient tracking
- Locating and tracking use of medical devices and support equipment
- Storage and care of blood products and specimens
- Management of hazardous waste
- Tracking of garments.
However, the use of RFID in the prevention of surgical errors presents perhaps the most important benefit to both patients and hospitals. It improves health outcomes, but it can also provide ROI to the hospital by reducing certain types of extreme surgical errors. These errors can not only cost the patients their lives or their quality of life, but they can also cost the hospital in untold bad publicity and millions from lawsuits.
About the author
David C. Wyld is the Robert Maurin Professor of Management and Director of the Strategic e-Commerce/e-Government Initiative at Southeastern Louisiana University.