Sponges Left in Patients

This recently happened to my grandfather after a surgery and now is featured in the Chicago Tribune.

Admitted to a Macon, Ga., hospital in 2004 for surgery for diverticulitis of the colon, Lucille Davis, then 67, left with an undetected and dangerous souvenir: a surgical sponge. Last month the error resulted in a $10 million settlement.

The problem of left-behind sponges is hardly new. A 2003 study in the New England Journal of Medicine reported that sponges and other foreign objects were left behind after abdominal surgeries at a rate of 1 for every 1,000 to 1,500 such operations.

Several medical-products companies say sponges are the most common foreign objects left behind in surgeries

The pressure to avoid unnecessary costs is about to get more intense. The Joint Commission, which accredits hospitals, is urging hospitals to develop systems to prevent errors. And beginning in October the federal Medicare program will not pay providers for procedures involving a foreign object left behind from a surgery, part of a new effort to curtail errors.
“In the past, retained sponges were treated as an institutional speeding ticket … but it has become more of an institutional DUI,” said Bill Adams, chief executive of SurgiCount Medical.

Technology is coming to the rescue of doctors and nurses, who for decades have kept track of sponges by manually counting them.

Sponges are made of gauze and are used to soak up blood and protect organs during surgery, but if left inside the body they can cause potentially deadly infections.

SurgiCount and its distribution partner, Cardinal Health Inc., are rolling out a bar-coding system that helps operating-room nurses and technicians keep track of sponges and other items.

Mundelein-based Medline Industries Inc., meanwhile, is winning over hospitals to its RF-Detect system, which alerts health-care workers via radio frequency that sponges are still in the patient before the doctor closes. Sponges, tagged with a radio frequency detection system, can be found after a wandlike device is waved over the wound, Medline said.

“It’s a giant issue,” said Jack Bowser, president of Medline’s primary-care division. “Clearly, adding any additional costs, you get a little push-back from the hospitals. But if you average only one retained object a year, [the system] pays for itself.”

Medline says RF-Detect, developed with its partner, Bellevue, Wash.-based RF Surgical Systems Inc., adds $50 to $60 per thoracic procedure. For comparison, having to crack back into a patient’s chest cavity to retrieve a sponge and treat an infection caused by a foreign object can cost $50,000 or more.

Increasingly, states are ratcheting up pressure on hospitals to make them more accountable, which could spur more interest in sponge-detection systems. Several states have instituted mandatory medical-error-reporting policies that require hospitals to disclose when they have made errors, or “never events,” like leaving a sponge in a patient.

Errors involving left-behind sponges can lead to more expensive liabilities if malpractice suits are successful against doctors and hospital staffs. Dr. Jan Adams, the plastic surgeon who operated on Kanye West’s mother before she died, lost a $100,000 default judgment to a patient who sued him in 1996 after she claimed he left a sponge in her body, according to press reports. Adams has denied the allegations, these reports state.

Medline says RF-Detect is gaining momentum. Although just 21 hospitals have committed to the new system, the company said an additional 38 hospitals have scheduled a trial over the next two months. RF Detect was launched in certain regions of the U.S. last spring and a national rollout is planned for early this year, Medline officials said.

Cardinal Health, too, says it is gearing up for a national commercial launch this year after several months of trials.

Cardinal has sold its bar-coding system, which swipes sponges under a scanning device to obtain a count, to six hospitals last year, with another three facilities coming on line in the first quarter of this year. Cardinal officials say the SurgiCount system costs about $12 to $15 a procedure.

30 hospitals in trials

“We have at least 30 hospitals in trials,” said Scott Donnelly, director of marketing for Cardinal Health’s presource business.

The market could be large, the companies said, citing industry figures indicating that more than 20 million chest procedures are performed in the U.S. each year. Procedures such as obstetrics and other surgeries could result in a potential market of more than 35 million applicable procedures, Cardinal Health said.

A large Indianapolis hospital that converted to Medline’s new sponge-detection system in December said it was encouraged in September to implement a system to assist with sponge counting by The Joint Commission, which is empowered by Congress to ensure the quality and safety of hospitals. Joint Commission accreditation is crucial to the financial health of a hospital because it allows facilities to treat federally subsidized Medicare patients.

“The Joint Commission told us that we had to implement something to assist with counting and assuring that our counts were accurate,” said Roberta Sutton, a registered nurse and resource coordinator for perioperative services at Methodist Hospital, an 810-bed facility. “It was not like you did not have a choice, but [Joint Commission officials] feel like the retained item is unacceptable.”

Although The Joint Commission says purchasing a sponge-detection system is not mandatory, it strongly encourages hospitals to look at all processes involved in the potential for foreign objects to be left in a patient. The commission said hospitals need to look at staffing and communication in particular, since the operating room involves multiple people in a high-stress environment.

“Preventing a tragedy requires a number of systems being in place, and The Joint Commission is taking this very seriously,” said Louise Kuhny, senior associate director of standards interpretation for the organization. “It does not have be automated. Technology always helps, but it is not always enough.”