A novel X-ray image database could assist radiologists in identifying medical equipment left inside patients' bodies after surgery, addressing a recurring problem involving items ranging from soft sponges and surgical masks to blades, needles and retractors.
Rosaleen B. Parsons, the inventor of the database and a radiologist at Fox Chase Cancer Center at Temple University Hospital, has filed a patent application for the system. It was published by the U.S. Patent and Trademark Office on April 8.
The prototype archives preexisting X-ray images of every medical device used in the operating room, or OR. It serves as a reference for radiologists, indicating what shapes or gradients they should look for in X-rays of post-surgical patients when searching for foreign equipment left behind.
"It's a database that would be embedded in the picture archive system called PAC," Parsons told The Academic Times. "It would be, basically, a catalog that the radiologists could access."
When such tools go unnoticed, patients are released from the hospital with potentially dangerous equipment resting near their organs. These occurrences are reported approximately 1,500 times each year in the United States. A 2018 study that examined 308 events of unintentionally retained foreign objects, chronicled over five years, found that five patients died as a result of such oversight.
In addition to causing major health detriments, retained surgical tools require extended hospital stays and multiple otherwise-unneeded surgeries for the affected patient. That can cost tens of thousands of dollars, at minimum. Subsequent legal consequences also cost the physician malpractice lawsuit fees and result in major fines for the affiliated institution.
"This is going to be owned by the surgeons and the radiologists to improve patient safety, decrease the time that the patient is potentially in the OR and [lower] medical legal exposure for the institution," Parsons said.
The radiologist explained that she was motivated to create the product by her own experience working alongside surgeons. After a surgery is completed, but before the patient leaves the table, staff in the operating room are asked to ensure that all surgical equipment used during the procedure is accounted for. If a discrepancy is found, radiology is phoned in.
At that point, Parsons explained, radiologists are asked to look at an X-ray of a patient in the operating room because something is missing.
"I realized," she said, "I often didn't know what I was looking for — it kind of bothered me, because you're limited in the imaging."
Parsons drew on a particular example regarding a "clip house," a tool used during surgery. After a surgery, if the count of medical equipment indicates that a clip house is lost, X-rays would be taken while the patient is still on the table, and radiology would be contacted to look at the images to see whether such an instrument appears. But what would happen if the radiologist doesn't know what a clip house is?
The easiest option would probably be to Google "clip house." But even after entering three separate queries — "clip house," "clip house surgical equipment," and "clip house medical tool" — and scanning the results for a minute or two, there is still no image of a clip house.
That's where Parsons' database comes in. Rather than use a layman's search engine, radiologists can look at an actual X-ray image of a clip house and quickly understand what shapes, lines or patterns would denote it in a patient's X-ray.
"The radiologist doesn't have to fumble to try to figure out what a clip house is," Parsons said. "You've got a picture archive right here at your fingertips, and you can say, 'No, we're good; there's nothing there.'"
In 2008, researchers found that traditional intraoperative imaging caught only 67% of the medical equipment left in patients. Parsons' patent application claims that other published papers place the statistic as low as 33%. One report from 2018 described a woman who suffered from abdominal issues because she had a sponge left inside her for nearly six years, undetected. The source was likely a routine cesarean section.
"I think this sort of device is almost going to be mandatory in operating rooms," Parsons said. "There's so much information out there, and there's so many different techniques and so many new instruments that are coming down the pike — it's impossible to try to keep on top of them."
Parsons' invention can also shift alongside the ever-changing field of medicine by leaving room for customization. Any hospital that implements it will be able to add new items, per the facility's associated surgeons, or delete items that aren't found in any of its operating rooms.
"We took X-rays of everything that could potentially be used in our OR and exported it in our picture archive system," she said. "That's where it can be customizable, because some people may use.different hemostats, etc."
The database also uses X-ray images of the item as opposed to normal images found online, for example. Because X-rays are taken from one-dimensional planes, it's easy to imagine that if a blade is pointing directly at the plane, it would appear as a singular dot. It would not look like a blade and so could easily be missed.
However, if an X-ray of a blade were provided to a radiologist, they'd be primed to know what that type of dot might indicate.
"It's literally like trying to find a needle in a haystack when you're trying to figure out which one of these lines is supposed to be there and which one isn't," Parsons said of standard X-rays. "If we can develop a system where you have a catalog of this — and maybe even an artificial intelligence so you can rotate it — you know exactly what you're looking for."
The application for the patent, "Retained Surgical Items," was filed Sept. 29, 2020 with the U.S. Patent and Trademark Office. It was published April 8 with the application number 17/036421. The earliest priority date was Oct. 7, 2019. The inventor of the pending patent is Rosaleen B. Parsons, and the applicant listed is the Institute for Cancer Research d/b/a The Research Institute of Fox Chase Cancer Center.
Parola Analytics provided technical research for this story.