The top administrator at the Togus VA Medical Center near Augusta says clinical staff were following recommended sterilization procedures and even took action to improve patient safety. But the hospital still will be included in a congressional investigation into surgical protocols at veterans health care facilities.
A report Monday from the VA inspector general to the U.S. House Committee on Veterans Affairs raised concern about sterilization procedures in VA health centers. According to the report, surgeons at the James A. Haley VA Medical Center in Tampa implanted an unsterilized surgical steel plate in the skull of a patient who had been injured in a car accident. The incident occurred in February.
A week later, the same facility narrowly avoided the same mistake in a different patient when the surgical plate didn’t fit. The report said operating room staff “incorrectly assumed that the implant and model were sterilized by the manufacturer.” In neither case was the patient adversely affected.
The report also referenced a sterilization problem at Togus and questioned whether VA health facilities lack a uniform process for ensuring the sterility of surgical equipment and prosthetics. In a statement issued Tuesday, the Veterans Affairs committee said it would hold a hearing to look into the problems.
Togus medical center director Jack Sims said Tuesday that the concern at the Maine hospital was of a substantially different nature from that in Florida. For one thing, it had nothing to do with an implantable or prosthetic device, but rather was associated with a piece of diagnostic equipment. Second, Sims said, it was the staff at Togus who identified the manufacturer’s recommended procedure for sterilizing the equipment as inadequate and took action to protect patients.
Sims said the equipment, an ultrasonic transducer that is inserted into the rectum and used to take samples of prostate tissue, initially was cleaned between patients according to the recommendations of the manufacturer, B-K Medical of Denmark. The process included using soapy water to flush a slender tube in a stainless steel guide that is used to navigate the tissue-sampling biopsy needle into place. After being flushed, the guide was soaked for 20 minutes in a “high-level disinfectant,” he said.
But in late January or early February, Sims said, the patient safety manager at Togus questioned whether the process was enough to protect patients from coming in contact with blood or fecal matter from other patients. The discovery came about as a result of the VA’s “aggressive patient safety program,” he said, and was reported to VA health officials in Washington.
Sims said Togus staff started sterilizing the transducer guide more thoroughly, using a brush to clean the inside of the tube before sterilizing it with pressurized steam. A review of the records of more than 500 Togus patients who have had contact with the transducer over the past three or four years shows no greater than normal numbers of complications that might have been the result of incomplete sterilization, he said. Such complications could include chronic viral infections such as HIV or hepatitis.
A call to B-K Medical’s U.S. headquarters in Massachusetts was not returned by the end of the day Tuesday.
U.S. Rep. Michael Michaud, who serves on the veterans committee, said in a statement Tuesday that Togus officials should be commended for recognizing and reacting to the problem, which he said arose “because of insufficient guidance and training provided to the VA.” VA officials have issued new guidelines for sterilizing the transducers, he said.
Michaud and others on the veterans committee also have written to the federal Food and Drug Administration to recommend a broader effort to alert health care providers to the public health risk posed by inadequately sterilized transducers.
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