FORSYTH COUNTY, N.C. — Novant Health Inc. said Wednesday three more brain or spinal surgical patients may have exposed to Creutzfeldt-Jakob disease at Forsyth Medical Center earlier this year.
The system also said three of the 18 patients initially identified and notified Feb. 10-11 are no longer considered at risk.
It is the first update by Novant since it disclosed publicly the exposure risk Feb. 10.
Jeff Lindsay, Forsyth’s president, and Dr. Jim Lederer, its top infectious-disease expert, said at that time the 18 patients may have been exposed to the rare but fatal degenerative brain disorder through surgical equipment used in procedures that occurred from Jan. 18 to Feb. 6.
A patient who had brain surgery Jan. 18 was later diagnosed with CJD through testing of tissue at Case Western University’s National Prion Center. Novant said the equipment used in those procedures was removed Feb. 6.
Novant spokeswoman Caryn Klebba said federal privacy laws prohibit the system from disclosing the gender of the patients.
“We made this new determination based upon an in-depth review of patient files, a review of the surgical instruments used, and an examination of when the instruments were sterilized,” Klebba said.
“We recognize this new information is disappointing to the three additional potentially exposed patients.
“However, we believe if anyone may have been potentially exposed to these surgical instruments, they have a right to know and we have a responsibility to tell them.”
When Novant announced its exposure risk, it was the latest of at least nine incidents at U.S. hospitals this century.
Lindsay has said that “any exposure is simply unacceptable” even as Lederer described the risk to the patients as “very low.” In 85 percent of CJD cases, it occurs spontaneously in the brain from a mutated gene – without warning or symptoms.
The disease is caused by a rare type of protein, or prion, that can adhere to surgical equipment and withstand standard sterilization treatments. The specialized surgical equipment used on the Forsyth patient with the disease did not receive the enhanced sterilization procedures recommended for CJD by The Joint Commission.
According to federal regulatory agencies, the last confirmed case of a CJD transmission though surgical instruments occurred in 1976. In the past 14 years, there have been about 4,900 patients nationwide who may have been potentially exposed to CJD in that manner.
Klebba said Novant brought in a national epidemiologist who is an expert in infection prevention and CJD.
“She conducted a significant review to validate our processes to ensure we were accurate in which patients were identified as potentially exposed,” Klebba said.
“Surgical instruments are used in a variety of surgeries and different operating room suites; therefore, in this second review we worked to match dates, times, types of surgeries and surgical instruments to each patient.”
Klebba said Novant’s standard procedures is to use disposable surgical instruments in cases where CJD is suspected where possible, and to apply enhanced cleaning processes to non-disposable surgical instruments to prevent possibly transmitting the disease to others.
“We have shared that although there were reasons to suspect CJD, it was determined that such a diagnosis based on clinical data was unlikely,” Klebba said. “We have also candidly shared that, in hindsight the enhanced sterilization should have occurred.
“We have changed our policy to now heighten awareness of CJD as a possible diagnosis and establish a reporting requirement to our infection prevention team in the case of potential CJD cases.
“We continue to use disposable instruments where possible and will quarantine any non-disposable surgical instruments used in cases of suspected CJD and, if confirmed, to incinerate the instruments,” she said. “Cost of the surgical instruments is not a factor in making this safety determination.”
Klebba said of the 18 patients currently considered at exposure risk, some are from other states.
“We have made all reports required by North Carolina and federal law,” Klebba said. She said officials with the N.C. Department of Health Service Regulation conducted a three-day survey Feb. 18-20 “to determine if we had corrected any underlying issues.”
“They determined that we had taken the necessary steps to prevent this from happening in the future. The Joint Commission has asked for additional information and has shared with us that they do not believe an on-site review is necessary.
“As a result of self-disclosing and taking immediate action to fix the issues, we do not expect to and have not received any sanctions.”
Klebba said Novant is declining to discuss any potential financial obligation to the patients, including paying for the cost of their procedures and subsequent testing. “We cannot discuss legal matters,” she said.