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Feb. 13--The potential exposure of 18 patients at Forsyth Medical Center to Creutzfeldt-Jakob Disease has gotten the attention of state health regulators and The Joint Commission, officials with those groups said Wednesday.
Both N.C. Department of Health and Human Services and commission officials say they are closely monitoring the incident. The commission is an independent nonprofit organization that accredits hospitals in the United States.
DHHS spokesman Kevin Howell said the agency has been assured by Novant that all potentially exposed patients have been notified.
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 Jan. 18. A brain biopsy later confirmed the patient had the disease.
The other 18 patients were exposed between Jan. 18 and Feb. 6, said Dr. Jim Lederer, a Novant Health Inc. infectious disease expert. Officials have not clarified whether the patients had a neurosurgical procedure performed or had surgery performed by a neurosurgeon using the affected surgical equipment.
The Winston-Salem Journal sent a series of medical and logistical questions to Forsyth and Novant on Wednesday. Jeanne Mayer, a spokeswoman for Forsyth, said in an email, "We're working on answering these questions. We want to make sure we're providing accurate information and need some time to do that."
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.
One patient, Amanda Morin of Silver Valley, said Forsyth officials contacted her Monday to tell her of her potential exposure. She had back surgery Jan. 29.
"The Joint Commission is aware of an incident at Forsyth Medical Center that is similar to what you described, but we can neither confirm nor deny the details," spokeswoman Katherine Looze said. She said the commission's Office of Quality Monitoring is evaluating the incident.
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 Creutzfeldt-Jakob Disease Foundation Inc.
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 Centers for Disease Control and Prevention and The Joint Commission, they suggest adherence to World Health Organization guidelines for surgical equipment exposed to the disease.
"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.
Doug Allred, a spokesman for Cone Health, said its policy "is to not reuse surgical instruments that are used on a patient suspected of having" the disease. Those instruments are disposed of as called for in CDC guidelines. They are incinerated."
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' Division of Public Health tracks cases of Creutzfeldt-Jakob disease. There were 22 cases in North Carolina in 2013, of which only one hereditary/familial and the others were of the sporadic version.
"North Carolina has never had a variant CJD case," Howell said. He said some of the 2013 cases occurred during 2012, "but they were not closed and reported until 2013 due to pending autopsies or other pending information."
Howell said DHHS could not comment on whether Forsyth and Novant face sanctions or enforcement actions. He deferred to the Centers for Medicaid and Medicare Services, which could not be reached for comment Wednesday.
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 World Health Organization.
"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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