Implant inquiry faults VA hospital

In two recent cases, Haley VA Medical Center staff failed to ensure cranial implants were sterilized. Now a House committee plans a hearing.

Published April 11, 2006

TAMPA - Staff members at James A. Haley VA Medical Center failed to ensure cranial implants used in two recent surgeries had been sterilized, according to an investigation made public Monday.

Since those incidents in February, Congress has learned about another case of improper sterilization of a medical device at a VA hospital in Maine.

These cases have raised broader questions about possible problems with sterilization and medical devices used in surgeries at the Department of Veterans Affairs and in private hospitals.

In a statement Monday, a subcommittee of the House Veterans Affairs' Committee said it would hold a hearing to look further into the matter.

"We are also requesting information from the Food and Drug Administration on the process of alerting the entire health care delivery system to potential sterilization issues regarding all invasive or implantable medical devices," the statement said.

The Haley investigation by the VA inspector general was prompted by two cases involving cranial implant surgeries in February.

In one case, on Feb. 21, surgeons inserted an unsterile plate in a patient who had been injured in a traffic accident, but investigators said they found no evidence he suffered complications.

A week later, surgeons averted a similar mistake because the implant did not fit the patient, who was injured by a roadside bomb in Iraq.

"The neurosurgeon tried to modify and fit the implant but felt that its placement was causing unacceptable pressure on the brain, as the patient's brain appeared to protrude out slightly from the normal contour of the skull," the report said.

"After considering alternatives to the prefabricated implant, the neurosurgeon stated that he felt that the best course of action was to terminate the procedure, clinically reassess the patient, and attempt a repeat cranioplasty at a later date."

That patient developed a fever of 101.6 degrees after surgery, but the infectious disease consultant "indicated a routine postoperative inflammatory response as the likely cause of the temperature."

A nurse who had been in the operating room during the surgery later raised questions about sterilization and the cranial plate, which was manufactured by Michigan-based Stryker.

"On the day following the Feb. 28 procedure, (operating room) staff became aware that the Stryker custom cranial implant itself also required sterilization by the facility," the report said.

In the end, the report said that safety procedures were not followed and that all Haley staff in the operating room "incorrectly assumed that the implant and model were sterilized by the manufacturer."

Investigators found the coordinator of operating room equipment had been on the job one month.

Although Congress did not find out about the incidents immediately, investigators concluded that hospital staff reported the problem up the chain, including the FDA, in a timely fashion.

But there were problems.

Initially, there was confusion over the number of patients who had undergone cranialplasties and whether unsterilized plates had been implanted. Hospital staff identified eight cases, all veterans of Afghanistan and Iraq, but later narrowed it to two.

Investigators also discovered an internal memo dated Oct. 7, 2005, that "recognized the difficulty in ensuring proper labeling and handling of sterile and nonsterile materials."

The report said Haley lacked a uniform process of delivering equipment to the operating room.

"In addition, there is no uniform process for determining sterilization needs of special order prosthetic products at the point of entry into the facility."

With 148,000 patients who logged in 1.5-million visits last year, Haley is the nation's busiest VA hospital.

Haley's polytrauma unit is one of only four in the VA system that specializes in treatment of a new generation of combat injuries caused by improvised explosive devices, commonly seen in Iraq.

As chairman of the Oversight and Investigations Subcommittee, Rep. Michael Bilirakis, R-Palm Harbor, said he wanted to make sure mistakes involving unsterile medical devices are not repeated.

He said the panel is examining how aggressively the VA is acting to take corrective measures.

"Today's report from the VA's Office of Inspector General identified several system failures regarding recent cranial implant surgeries at the James A. Haley VA Medical Center," Bilirakis said. "Thankfully, it does not appear that any patients were harmed in these incidents."

Spokesman Phil Budahn in Washington said the VA would have no comment.

The inspector general recommended that Haley review safety procedures.

In response, the VA said that it would monitor Haley from headquarters in Washington and that it would work with the FDA "to determine whether more universal safety checks should be applied."

--Paul de la Garza can be reached at delagarza@sptimes.com or 813 226-3432.