Surgical Sponges/Towels Left Inside The Patient Body: RFID Technology To Prevent Medical Malpractice, Improve Patient Safety
[Editor’s Note: For earlier related injury prevention/medical malpractice articles relating to surgery sponges left in a patient’s body:
Update on Injury Prevention/Medical Malpractice Prevention in Hospital Operations:
I have written a series of articles focusing on simple methods of preventing injuries/medical malpractice in the hospital operating room setting, involving surgical sponges/towels left inside a patient’s body. The medical field calls this “retained sponge” situations, but patients suffering this malpractice just find out that they have a major infection and need to have a second surgery-and they usually retain an injury lawyer like a member of my Virginia Beach, Virginia (VA) injury law firm.
These types of medical errors should never happen, and do not involve any “complication” of surgery. They are simple administrative matters (“mistakes”) that can be prevented and reduced and nearly eliminated, especially with the advent of new computer aided technologies.
A few weeks ago I wrote about a company that has invented a simple method of placing a bar code on each surgical sponge, and provides a barcode reader wand. The company SurgiCount has its products in a number of hospitals, and reports terrific success in reducing the number of lost surgical sponges that can cause an infection in the patient, which exposes the hospital or surgeon to medical malpractice liability. And that liability is not speculative–it is generally clear liability to the patient. Accordingly, the focus of my articles is to beam the spotlight on hospitals which can no longer rationalize failing to use these new technologies to reduce medical malpractice claims. The return on investment (in reducing medical negligence claims) is simply obvious. Even if every dime is not recouped in the hospital procedure, the ROI in eliminating medical malpractice infection or death claims makes the equation simple. Since my last article I received e-mail from other representatives of companies with technologies that can also reduce the number of patients who have surgical sponges or surgical towels left inside their body by accident.
Another company is using radio frequency identification (RFID) methods on surgical towels or sponges– yes, the same technology that is being placed on some consumer products along with bar codes. RFID technology allows for tracking of a product a little bit like a global positioning system, but on a much more simple basis because it is not being tracked by satellites but can be located by a nearby computer wand in a hospital setting.
A medical doctor, Jeffrey Port, received US patent protection, and FDA approval, for applying RFID technology to a surgical sponge or surgery towel, and the company argues that its technology is better than bar code readers on surgical sponges for the simple reason that the barcode reader can tell the staff if one surgical sponge is missing but there is no way to absolutely confirm that the surgical sponge was in fact sewn up inside the patient’s body. The RF Surgical Systems representatives argue that the advantage of the RFID technology is that the staff can simply run a wand over the patient’s body and confirm that in fact a towel or sponge is located in the cavity of the patient eliminating any frantic search or lingering question, before the patient’s surgery is over.
Because I am an inquisitive United States inventor myself, I am intrigued at how easily hospitals can avoid medical malpractice and liability for these errors, so my intention is to publicize how inexpensive and easily most of these medical malpractice claims can be avoided. I like to say that I may be the only prolific U.S. inventor/designer who is also a personal injury/faulty product lawyer for victims.
RF Surgical Systems is headquartered in Bellevue, Washington and was founded by Dr. Jeffrey Port, a thoracic surgeon, and Mr. William Blair, an electrical engineer, and the company’s website is www.rfsurg.com . Its RFID products are being distributed by Medline headquartered in Mundelein, IL, which also distributes more than 100,000 products to hospitals, and surgery centers. RF Surgical Systems has successfully convinced 60 hospitals in various parts of the United States to implement its RFID systems in order to reduce medical errors/medical malpractice. So how does it work?
The RF surgical system uses a wand detection system that incorporates three components to eliminate the retained sponge: 1) a 4mm X 12mm hybrid RF chip/tag that is sewn/incorporated into all forms of sponges/gauze/towels and eventually will be applied to surgical instruments, 2) the second component is a 14 inch wand that is waved over the patient after a surgical procedure. The wand is married to the RF tag and has a range of 16-24 inches through blood, tissue, and bone; and 3) the final component is a small console that emits an audio/visual tone/signal to alert the surgeon that there is a sponge in the patient.
The best part of the RF system is that it can wand the table, floor, trash, etc in the operating room as well. This is particularly advantageous if there is an “incorrect count”. The RF system is designed to allow the doctor/surgeon to have the rapid ability to find the sponge/towel either inside the patient or wherever it may be in the surgical setting.
Dr. Jeffrey Port, the surgeon who invented and obtained patent protection on the system, states: “Surgical sponge miscounts have been a recurrent and troubling issue in the operating room. Sponge miscounts most frequently occur in long, complex open cavity surgeries in patients with significant blood loss or in high BMI patients. These cases are further complicated when they involve a change in nursing staff or surgical teams.” He goes on to note, “As a surgeon ready to start closing procedures, it is critical to know: “Is there a sponge left in my patient?” And, if there is a sponge count discrepancy, the question then becomes: “Where is the missing sponge?” In answering these questions, I did not want to subject my patients to additional anesthesia while the OR was searched to locate the missing sponge or to wait for an x-ray to be ordered, taken and read to determine if a sponge was indeed left inside the patient."
According to an article by Milan Korcok, (Canadian Medical Ass’n, 2009) hospitals in the US have increased their spending by more than 200% since 2005 on electronic tracking systems that can locate wandering patients and misplaced equipment, detect errant blood transfusions and prevent medication errors, as well as sound alarms when surgical sponges are left in wrong places, like inside patients.
Korcok notes that Spyglass Consulting Group, which tracks information technologies, says that 76% of US hospitals with more than 300 beds have invested in radio frequency identification, and he adds: “Unlike their bar code precursors, which require line-of-sight scanning and individual handling, radio frequency identification readers can identify hundreds of tagged objects at a time, even if piled in unruly stacks, covered by surgical sheets or hidden in crumpled bedclothes. Their use has even been recommended to store medical information under the skin of patients.”
Korcok touched on “privacy concerns” with RFID, but as for surgical sponges, such devices should never be actually inside a patient so it is hard to really understand where the privacy issue concern would come into play. On the other hand, and of more concern, is the question of whether the frequency necessities of these devices could interfere with other vital medical devices such as pacemakers or ventilators.
I posed a few questions to Greg Allen, a representative of RF Surgical Systems, touching on some of the cutting edge RF issues that were on my mind:
Shapiro: One recent study indicated that, in test settings, radio waves from radio frequency identification devices sometimes switched off ventilators, stopped syringe pumps and caused external pacemakers and dialysis machines to malfunction. How have you addressed these concerns at your company?
Allen: In the JAMA article the majority of interference occurred at high (er) frequencies with active RF technology. The decision by our company to go with a hybrid technology between radar and RF was also an economic decision. We can manufacture our unique patented technology for that has proprietary filtering that has allowed us to experience no false positives with other operating room equipment. We have no reports of any interference with life saving equipment such as dialysis machines; however, in our product training materials we address the fact that during scanning, a temporary pacemaker should be turned to the VOO/DOO mode. (this is an asynchronous mode that eliminates any propensity for inhibition of the temporary device).
Shapiro: Compare your costs per open cavity surgery, per annum, at a typical hospital vs. bar code embedded systems. Why pay more for RF?
Allen: My information shows that the Surgicount Bar Code is the least expensive (around $12-$14 per procedure) and our RF Surgical is slightly more expensive (in the $15 per procedure range) We have lowered the cost with our multi usage 24 hour wand. (our initial FDA submission was a onetime use $50 wand–now we average 3 patients per wand). The RF System finds the lost sponge, regardless of where it is. We scan the patient first, then the table, floor, and the trash cans. The RF System allows you to find the elusive sponge. A bar code counting system only counts, and remember that 88% of all retained sponge cases result in a reported correct count.
Shapiro: Explain why patient privacy concerns are unfounded (I assume the RFID embedded device is never intended to leave the hospital room at all (if inside the body, the surgeon gets it out…) Please comment as to these “privacy” concerns as to RFID devices.
Allen: The actual RF chip is integrated in the individual sponge; therefore, if there is no retained sponge in the patient, (our primary business mission) a sponge/tag/chip would never leave the OR where the surgery was performed. All RF tagged products are disposed of after usage. The RF Surgical System has no data portion to the technology; therefore, no information is transferred.
Shapiro: Thank you for taking the time to answer these questions!
My take: RF technology is certainly one wave of the technological future of the hospital operating room, and importantly is an easy method to prevent "never events" involving lost sponges or surgical towel medical malpratice, and certainly is going to be rolled out to surgical instruments and tools that could break off inside a patient’s body (question: what part of the instrument do you put the RFID on?). Also, simple bar code systems that can back up the manual count of a nurse in an operating setting are also good, automated methods that will help avoid hospital errors and medical malpractice as well. The easier the solution, the more obvious the surgeon or hospital liability for careless acts!
About the Editors: Shapiro, Cooper, Lewis & Appleton personal injury law firm (VA-NC law offices ) edits the injury law blogs Virginia Beach Injuryboard, Norfolk Injuryboard, as well as the Northeast North Carolina Injuryboard as a pro bono service to consumers. Lawyers licensed in: VA, NC, SC, WV, DC, KY, who handle car, truck, railroad, and medical negligence cases and more.