OP-marks, Inc. is introducing a new hybrid ink for surgical site marking, in an effort to reduce the risk of surgical errors such as operating on the wrong body part, patient or performing the wrong procedure.

by Amanda McGowan, Editor, Surgical Products

The data on the frequency of wrong site surgery is conflicting. A study supported by the Agency of Healthcare Research and Quality (AHRQ) discovered a rate of 1 in 112,994 cases of wrong-site surgery in an analysis of nearly 3 million operations between 1985 and 2004. In 2007, the Patient Safety Authority in Pennsylvania reported data showing that every other day in state's healthcare facilities, an adverse event or near-miss of a wrong-site surgery occurs. Arguably, if these events occur so frequently in one state, chances are high they're happening in other facilities just as often.

No matter frequency, the consequences can be detrimental to the patient and the hospital. In January 2009, the Centers for Medicare & Medicaid (CMS) updated the list of 'never events' that will not be reimbursed to include three more errors: Wrong surgery performed on a patient, surgery performed on the wrong body part of a patient and surgery performed on the wrong patient. If a hospital commits these errors, it is responsible for the operation costs of the event and any subsequent procedures needed. Patients who fall victim to these errors during surgery can suffer serious health problems such as infection and even death.

"These events are causing us all to take much more time and consideration with our patients," says Sean Berry, RN, CNOR, MPA, and an OR Director in Georgia. "But it's still happening frequently around the country because the surgical staff is pushed to move faster, with less people doing more. That's how this happens. And when it happens, it is big news."

Efforts to reduce these 'never events' date back to 2004, when the Joint Commission introduced the "Time Out" process required before all surgeries to reduce the risk of these surgical errors, and mandated that lateral surgical sites be marked prior to surgery with an indelible marker so all marks are visible after the patient has been prepped and draped for surgery.

According to Berry, the required indelible pen marking means one thing to surgical professionals-a Sharpie.

"Sharpies are great markers," Berry says. "We use them all the time in the OR for many things, but they're absolutely not meant for the skin."

However, the Sharpie has been one of the few options for hospital operating rooms to truly comply with the TJC standards, even though the ink can irritate a patient's skin around the surgical site. Other surgical site markers struggle to stand up to the high-alcohol content preps used prior to surgery. The key ingredient in these markers gentian violet, which is an FDA approved ink for marking, and is easily wiped away by high-alcohol preps. So, by the time the patient is prepped, draped, and ready for incision, the markings have been wiped of during the prep, increasing the risk of a surgical error.

"That's what every operating room nurse in the country trying to satisfy TJC mandates in an operating room is having trouble with-" Berry says, "making that mark last through the prep and be visible for the surgeon just prior to the incision."

Having observed two wrong surgical procedure events in facilities in 30+ years, Berry decided to take finding a solution into his own hands. In 2004, he and a colleague who is a plastic surgeon founded OP-marks, Inc., in Bogart, GA, a company providing surgical site marking solutions, and in five years, developed several products solutions to solve the problems with surgical site markings in the OR-and ultimately prevent never events such as wrong site surgery.

The company offers surgical site mini skin markers, temporary skin tattoos, and surgical site stamps, to help hospitals mark the surgical site more accurately. Berry, who is now the Clinical Director for the company, explains OP-marks currently utilizes gentian violet in its ink for its products, but has tweaked it in an attempt to make it last longer in the face of high-alcohol content preps. He says that some gentian violet inks stand up to skin preps better than others, but currently none can totally withstand the high-alcohol content preps. The OP-marks formula in their markers now, while some fading is seen with some of the high-alcohol preps, stays visible for the surgeon.

While Berry says feedback for OP-marks products has been positive, and he uses them in his own OR, the company still felt a better solution was possible. Recently, in coordination with Georgia Institute of Technology, OP-marks developed a new hybrid ink to be used in its surgical site marking products.

The hybrid ink has not been implemented into any of OP-marks' products quite yet-Berry anticipates availability in early summer-but the ink has proven to stand up to all Chlorhexidine preps. The new ink is a hybrid formula that combines the pigment with key components to yield a completely durable marking solution.

"It's a significant jump forward because it withstands all the preps," Berry says. "And it's a whole lot closer to what the Joint Commission was looking for when they came out with these rules 4 or 5 years ago."

OP-marks is currently developing the delivery device for the new hybrid ink, and Berry believes it will be a pen comparable in design to the company's current products - inexpensive and small in size for a reduced environmental footprint. Full-sized marking pens are costly and use a lot of material, and as Berry puts it, "the rule is one pen per patient per procedure." The smaller pens developed by OP-marks replace their larger counterparts with what could otherwise quickly become a costly endeavor for surgical facilities.

"With the new level of skin infections out there, cross contamination from one patient to another has to be eliminated," Berry says. "This is a single patient use product. It's a disposable product that is cost-effective enough that you can use one per patient and not hurt the bottom line of a facility."

In the end, OP-marks' hybrid ink will provide hospitals not only a cost-effective, compliant solution for surgical site marking, but hopefully a solution that truly works to reduce wrong site, wrong procedure and wrong patient errors, for the sake of the patient and the hospital.

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