Print

Email story

Comment

Email editor

Haley doctors used unsterilized implant

A House committee wants an investigation after the VA center reports one implant problem and a near-miss on another.

By PAUL DE LA GARZA
Published March 14, 2006

TAMPA - Surgeons at James A. Haley VA Medical Center implanted an unsterilized cranial plate in a patient last month and nearly duplicated the mistake a week later, authorities confirmed Tuesday.

The patient with the implant suffered medical complications, a federal health official said.

A second mistake was narrowly averted on Feb. 28 because the patient was unfit to undergo the procedure. Hospital staff later discovered the cranial implant scheduled to be used had not been sterilized.

The revelations came out Monday at a hastily arranged briefing for congressional staff members by the Department of Veterans Affairs.

The House Veterans' Affairs Committee has demanded an investigation of both incidents, meaning more scrutiny for a hospital that already is the focus of federal inquiries into poor patient care and fraud.

Anger over the surgical problems deepened when officials learned that Haley waited almost two weeks before alerting anyone outside the hospital, including VA headquarters in Washington.

Haley, the busiest VA hospital in the country, has one of four "polytrauma" units that specialize in treating a new generation of injuries caused by improvised explosive devices, common in Iraq.

In a sign of frustration with Haley, a letter demanding the investigation was signed by the chairman of the House committee, the ranking Democrat, and five committee members from Florida.

"Of concern are the incidents themselves with their potential serious health risk to patients, as well as the 10-day delay in reporting the incidents to higher levels of VA management," the letter said.

Citing the 10-day delay, the committee said Haley and the regional VA administration in Florida could not be counted on to conduct an internal investigation. The committee asked the inspector general to report his findings no later than April 12.

In a statement Tuesday night, Rep. Michael Bilirakis, R-Palm Harbor, said medical errors are not unique to the VA health care system.

"But," he said, "I am extremely concerned about the recent incidents involving unsterilized cranial implants at the Tampa VA."

Bilirakis, chairman of the House panel's Subcommittee on Oversight and Investigations, said it's important to understand what happened to make sure it doesn't happen again.

In an e-mail to the St. Petersburg Times, VA Deputy Inspector General Jon Wooditch said investigators "will be conducting a full review" of the surgeries.

Separately, Wooditch said investigators will look into allegations of a fly infestation at operating rooms at Haley.

Haley already is the target of investigations by the inspector general into poor patient care, possible fraud involving a University of South Florida contract, and civil rights abuses and identity theft at the hospital police department.

Spokesman Scott Hogenson said Tuesday the VA could not comment on investigations by the inspector general.

The latest problems came to light Friday night when, in a rare move, the VA told Congress it needed to brief members about recent inpatient surgeries at Haley.

"While there have been no patient deaths or identified negative results from the surgeries to date, VA believes that the situation warrants an expedited briefing," stated an e-mail by Rob Merchant, a VA congressional relations officer.

Underscoring the severity of the situation, Dr. Michael Kussman, principal deputy under secretary for health at the VA, briefed congressional staff Monday afternoon.

In outlining both cases, Kussman indicated some complications with the patient who received the cranial implant, but he did not provide details.

Kussman said the cranial implants were manufactured by Stryker, a medical company based in Michigan. Patrick Anderson, a Stryker spokesman, said the company was unaware of the investigation. He said some company products used in cranial surgeries are sterilized and prepackaged by the manufacturer. Other company products have to be sterilized by hospital staff members.

Anderson said the type of implants used at Haley could be sterilized and prepackaged or they could require sterilization by the hospital. He said it depended on the type of material used to make it.

Anderson said he did not know how many products Stryker supplies the VA. It could not be determined Tuesday if other VA hospitals have had sanitary problems with Stryker equipment.

The cranial implants, or plates, can be made out of various materials, including steel or titanium, and are used in reconstructive surgery of the skull.

With 148,000 patients who logged in 1.5-million visits last year, Haley is the nation's busiest VA hospital. The hospital registers about 6,000 visits per day, based on 252 working days per year.

Haley is not the only VA hospital in the region undergoing an investigation by the inspector general.

Bay Pines VA Medical Center in Pinellas County is under investigation on allegations of mismanagement and poor patient care.

[Last modified March 14, 2006, 23:21:02]