Health regulators noting Forsyth incident
|By Richard Craver, Winston-Salem Journal, N.C.|
|McClatchy-Tribune Information Services|
DHHS is "in close contact" with Novant "to insure that the appropriate actions are being taken with regards to steps necessary to prevent future exposures," Howell said.
Forsyth officials said Monday that up to 18 patients may have been exposed to the disease, a rare but fatal degenerative brain disorder. The center said a neurosurgical procedure was performed on a patient
The other 18 patients were exposed
Lederer said patients were identified through tracing when the equipment was used during the 19-day period.
Although Lederer said the exposure risk to the other 18 patients "is very low," he added the hospital "realizes this is devastating news" to have to provide to those patients and their families.
Mayer said privacy laws "prevent us from talking about a patient's specific treatment," including how hospital officials determined that the patient had the disease. Officials have not identified where the patients live.
Looze did not say whether Forsyth and Novant are facing potential sanctions because of the exposure.
The disease affects one in 1 million patients worldwide annually, or about 300 Americans a year, and has no known cause or treatment. Symptoms in some instances may not appear for years, if not decades.
However, death typically occurs within a few weeks to four months of symptoms arising, according to Novant and the
Less than 1 percent of cases of Creutzfeldt-Jakob disease are acquired through iatrogenic and variant exposure.
Among the iatrogenic risks are contaminated surgical instruments, dura mater transplant, corneal transplant and human growth hormone. The variant risks can come from eating contaminated beef or being exposed to contaminated blood or a blood plasma transfusion.
The last confirmed case of a transmission though surgical instruments occurred in 1976. Novant said there have been only four confirmed cases of such transmission in the world.
The sporadic version of the disease accounts for 85 percent of the annual cases, including the Forsyth patient who has been identified with the disease. A hereditary version accounts for about 14 percent.
The hospital said the exposure occurred this way: The specialized surgical equipment used on the patient with the disease was cleaned through a typical sterilization procedure, but did not receive the enhanced sterilization procedures required for Creutzfeldt-Jakob.
The disease is caused by a rare type of protein that can adhere to surgical equipment and withstand standard sterilization.
According to the website of the
"Destruction of heat-resistant surgical instruments that come in contract with high infectivity tissues, albeit the safest and most unambiguous method as described in the WHO guidelines, may not be practical or cost effective," the CDC said. It is not clear how much the specialized surgical equipment costs.
The WHO guidelines recommend using one of three "stringent chemical and autoclave sterilization methods."
Lederer said there were "reasons to suspect" that the patient had the disease or another brain disease at the time of the surgery. "The extra cautions should have been taken, but were not," he said.
Allred said it typically takes about two weeks for a biopsy of potentially infected tissue to determine whether the disease is present.
Howell said DHHS could not comment on whether Forsyth and Novant face sanctions or enforcement actions. He deferred to the
Howell said DHHS recommends that "neurosurgical instruments used to treat patients whose diagnosis is unclear, particularly for brain biopsy, should be regarded as potentially contaminated with the CJD agent."
"Such instruments should be quarantined until a non-prion disease diagnosis is identified or should be sterilized using CJD-decontamination protocols recommended by the
"State licensure rules and CMS federal regulations require health-care providers to have policies and procedure to ensure standards in infection control are implemented. This includes protocols that address the cleaning and sterilization process of surgical instruments," said Howell.
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