An RF Surgical sponge
with radiofrequency tags

New advances in the war against "never events"

November 01, 2012
by Loren Bonner, DOTmed News Online Editor
One day, during his shift managing a PETCO store in Orlando, Fla., Lenny LeClair had stomach pain. After suffering a few agonizing days with the hope it would go away, he finally went to the hospital. Doctors diagnosed diverticulitis, a digestive disease that normally requires part of the colon to be removed. After his final surgery to reconnect damaged tissue, LeClair went home to recover. But three months later, things got even worse.

“All of a sudden I started throwing up from sun up to sun down, even throwing up feces,” he says. This went on for a while until LeClair lost consciousness. When he woke up in the hospital after being in a coma for three weeks and having an emergency surgery performed, he was told that sponges had been left inside him after his surgery months ago.

“What it had done was pierced my colon so all those toxic fluids were going right into my body,” says LeClair.

Five years later, LeClair says things have only gone downhill further.

“I can’t get insurance and I can’t have other surgery I need done so I live 24/7 in pain,” he says.

He brought home less than six hundred thousand dollars when the hospital settled with him. Since he’s too sick to work, he says he’s lived off most of that settlement money and shelled out a majority of it for expensive medications.

“I get emotional when I talk about it. I think my life has gone down the tubes and I was a successful man,” says LeClair.

Thousands of adverse medical events that happen each year in the U.S., like LeClair’s, are the result of items left in a patient’s body after surgery. These objects can range from clamps and forceps to scissors. But gauze-like sponges used during an operation account for about two thirds of all retained items.

The landmark 1999 Institute of Medicine report, “To Err is Human: Building a Safer Health System,” which found that U.S. hospitals kill at least 44,000 patients a year, compelled the medical establishment to improve patient safety. But statistics remain dismal to this day.

Small steps for big changes
U.S. surgeons operate on the wrong body part as often as 40 times a week, and roughly a quarter of all hospitalized patients will be harmed by a medical error of some kind, according to a recent Wall Street Journal article by Dr. Marty Makary, a surgeon at Johns Hopkins Hospital and a developer of surgical checklists.

“These mistakes go largely unnoticed by the world at large, and the medical community rarely learns from them. The same preventable mistakes are made over and over again,” he writes.

Many hospitals have taken it upon themselves to put a stop to preventable medical mistakes. And many are simple fixes.

Beth Israel Deaconess Medical Center in Massachusetts just released results of a five-year effort to eliminate preventable harm by 2012. The report concludes that the center has reduced these events by half through “hundreds” of small, low-tech changes like chair alarms, lower bed heights and socks with tread on the bottom—all aimed at eliminating falls, a common cause of patient injuries.

While other hospitals might not have such ambitious plans, technological innovations and initiatives focused on changing the culture around patient safety are slowly catching on.

Technology vs. man
Surgical checklists are widespread and are just one simple way teams have worked toward patient safety. Feedback from one perioperative nurse complaining that there were too many checklists to reference during procedures prompted the Association of Operating Room Nurses (AORN) to introduce a comprehensive checklist in 2010 based on the World Health Organization’s Surgical Safety Checklist as well as the Joint Commission’s Universal Protocol.

Although these checklists are ubiquitous, and when used correctly, can make a difference, they are often not enough.

According to a study published in the October issue of the Journal of the American College of Surgeons, technology does a better job of tracking sponges used during surgery. Researchers at the University of North Carolina at Chapel Hill looked at 2,285 cases where sponges were tracked with a radio-frequency technology called RF Assure Detection from the Bellevue, Wash.-based RF Surgical Systems Inc. Since each piece of sponge is marked with a tag about the size of a Tic-Tac, the system’s outside detectors—a mat or a wand—can alert clinicians if sponges are still present. According to the study, the system helped recover 23 forgotten sponges from roughly 3,000 patients during an 11-month period.

In most operating rooms, a nurse keeps a manual count of the sponges used during a procedure, but experts agree that anything geared toward enhancing sponge tracking is better for the patient.

An RF Surgical wand to
detect tagged sponges

Roughly 200 hospitals around the country have adopted RF Surgical’s technology since it received Food and Drug Administration approval almost five years ago. The company’s president and CEO, Kevin Cosens, expects more hospitals to budget for it this year.

“As with any new technology, it takes a while to get hospitals to adopt, and initially hospitals want to see independent clinical data, which we have now but we didn’t have until last year,” he says.

Organizing around patient safety
The Patient Safety and Quality Improvement Act was signed into law in 2005 with the intention of fostering a culture around patient safety. Within the law, Patient Safety Organizations were created so that health care organizations and related groups could share and analyze information related to patient safety events in a protected and educational way. Regulations for PSOs were finalized in 2009 and ECRI Institute became one of the first to sign on.

“We learn from what everyone is submitting. Rather than keep it within one organization, if you bring it together, you can learn more,” says Barbara Rebold, director of PSO operations at ECRI Institute.

Keeping with that idea, in 2004 Pennsylvania became the first state to require health care providers to report adverse events. The law says that Pennsylvania hospitals must report near misses and serious events via a confidential reporting system. Today’s PSOs are based in large part on this existing system— except for one major caveat: providers report to PSOs on a voluntary basis.

Rebold says the nature of voluntarily reported information has not hindered what can be discovered from the data.

“There’s a lot to learn but it’s not benchmark data, it doesn’t represent everything. But I can tell you that of over 125,000 events in our voluntary [database] and in Pennsylvania’s over 2 million events, we see the highest volume of reports are falls, medication events and pressure ulcers,” she says.

More than 70 groups are certified PSOs—they range from dedicated health care bodies like ECRI Institute’s to small and large hospital systems to software vendors.

As they grow, supporters want to see them become more integrated within health IT to create the most robust information possible. This includes not just electronic health records, but pharmacy ordering, lab systems and radiology systems.

Currently, at least 27 states have laws that require hospital-acquired infections (HAIs) to be reported. In addition, in order to receive Medicare payments, hospitals must track and report medical errors, although a recent report from the Department of Health and Human Services finds hospital employees are actually only reporting medical errors about one in seven times.

Innovating around PSOs
GE Healthcare’s PSO will officially launch what it calls the Global Patient Safety Network commercially in January 2013. It will be available first through the GE PSO and over time to anyone in health care, according to Jeff Terry, general manger of operations solutions development at GE.

“It’s like any social media platform but tuned exactly to patient safety,” says Terry. GE launched the evaluation period in April with 63 hospitals and seven private communities.

Discussions are grouped by type of patient safety events, like medication errors, and by specialty. There’s also a section where participants can ask for advice.

Terry says he hopes this tool, in addition to PSOs, will finally get providers comfortable sharing and talking about patient safety.

“The biggest challenge is getting past blame and getting to a deeper understanding of the root cause,” he says.

Getting patients involved
One of the latest efforts to improve patient safety will seek input from patients and their families. In September, it was announced that the Agency for Healthcare Research and Quality is seeking approval from White House Office of Management and Budget for a prototype of a patient reporting system, which will ask patients to report medical mistakes through a private system. In a statement from AHRQ to federal officials, they say there is growing evidence that many adverse medical events go unreported in the current system and a significant reason this occurs is because most systems do not include reports from patients and their families. AHRQ says a more accurate and complete understanding of adverse events will help make health care safer.