Refurbished external fixators as good as new

Study finds no difference in complications between new and reused external fixators.

A Boston University study found that refurbished external fixators are as safe and effective as new devices for treating traumatic injuries, with no difference in complication rates noted. However, 69% of eligible patients refused entry into the trial, limiting the overall cost savings of the reuse program to $65,000.

“With increased use of external fixation devices for both temporary and definitive surgeries, and their higher cost compared to plates and screws, there is interest among hospitals in reuse of nonimplantable components,” said Jinsil Sung, MD, of Boston University, who presented the study findings at the Orthopaedic Trauma Association 21st Annual Meeting.

Sung and colleagues prospectively evaluated a third-party processing program that refurbished Stryker Hoffman external fixators. They enrolled 96 of 313 eligible patients over a 30-month period. The investigators randomized patients to treatment with all-new components or refurbished nonimplantable components.

All patients were independent, consenting adults with either distal radius, pilon or plateau fractures requiring external fixation for an average of 5.1 weeks.

Decontamination process

FDA regulations introduced in 2000 and the Medical Device User Fee and Modernization Act of 2002 hold third-party processors to the same regulations as original device manufacturers. The regulations also require recycled products to be as safe and efficient as original devices, Sung said.

To comply with these regulations, third-party processor completed a decontamination process starting with an enzymatic bath to remove proteins and lipids. Next, the devices underwent a sonication bath with acid and hydrogen peroxide solution to reduce bioburden levels. Stainless steel devices also went into a third bath containing a rust inhibitor.

Finally, the processor magnified each device to check for nicks, cuts, scratches and rust, and rolled each rod on a calibrated block to ensure straightness. The devices went through a final autoclave steaming process before shipping.

Investigators found that about 20% of devices sent for refurbishing were discarded. “Most of the 20% of components that were not refurbished were for cosmetic reasons — scratches, nicks and rust,” Sung told Orthopedics Today.

Comparable results

At the time of removal, researchers evaluated all pins and recorded any complications, including clinical loosening and radiographic reduction losses. With the small number of patients enrolled, researchers could not find a significant difference between the two groups.

They found pin tract infections in 45% of the all-new components group and in 52% of the refurbished components group (P=.32); loss of fixation in 3% of the all-new components group and in 4% of the refurbished components group (P=.7); and component loosening in 1% of each group.

Three patients in each group lost reduction because of frame loosening or pin motion, requiring revision and device removal, according to the study abstract.

Given the complication rates between the two groups, the investigators were clear that it would take at least 1500 patients in each group to make an adequate power comparison, Sung noted.

In evaluating cost savings of the reuse program, the researchers found that refurbished frame components cost 54% less than new ones. Because 69% of patients refused study entry, the actual cost savings for the study was $65,452 (the difference in the new and refurbished frames for the actual number of patients receiving refurbished frames). However, if the entire patient population had agreed to participate, the researchers estimated a savings of $208,262.

Despite these results and FDA regulations, hospitals continue to use new external fixators, and public attitude about the reuse of medical devices remains unknown, Sung said.

“The perceived biohazards of recycled medical devices and liability of reuse must be carefully balanced with potential healthcare savings,” Sung said. “The U.S. market for reprocessed medical devices is $1.4 billion. It’s estimated that 25% of hospitals participate in such programs.”

For more information:
Tornetta P, Einhorn T, Creevy W, et al. Reuse of external fixation components: a prospective randomized trial. #6. Presented at the Orthopaedic Trauma Association 21st Annual Meeting. Oct. 19-22, 2005. Ottawa.