Thursday, April 17, 2014

Novant: Three more may have been exposed to disease CJD

Novant: Three more may have been exposed to disease


Related Stories Related: Woman wants answers from Forsyth Medical Center


Related: 18 patients exposed to deadly disease at Forsyth Medical Center


Posted: Thursday, April 17, 2014 9:02 am


Novant: Three more may have been exposed to disease


By Richard Craver Winston-Salem Journal


WINSTON-SALEM — 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.



North Carolina Hospital Potentially Exposes Patients To Deadly Disease



could not find this report on Novant public news feed yet...TSS




18 neurosurgical patients at Forsyth Medical Center may have been exposed to CJD during surgery


Winston-Salem, NC February 10, 2014 – Novant Health Forsyth Medical Center has learned that 18 neurosurgical patients within the last three weeks may have been exposed to a rare degenerative brain disease while undergoing surgery at the hospital.


The disease, sporadic Creutzfeldt-Jakob Disease (CJD), affects approximately one person per million worldwide, and has no known cause. The possibility of contracting CJD through surgical exposure is very remote. The last confirmed case of a patient acquiring CJD through the use of surgical instruments was in 1976.


Forsyth Medical Center staff have reached out to all 18 patients to inform them of the potential risk, and all surgical instruments used in the surgeries have been put through enhanced sterilization procedures, as recommended by the Centers for Disease Control and Prevention.


“On behalf of Forsyth Medical Center, I want to offer my sincerest apology to the neurosurgical patients who may have been exposed to CJD while undergoing surgery at our hospital,” said Jeff Lindsay, Forsyth president and CEO. “We recognize that the risk to these patients is very small. However, we take any potential exposure seriously, and are here to support these individuals and their families both now and in the future. We have taken appropriate steps to prevent any future occurrence. We value the trust our patients place in us, and we remain fully committed to the health and safety of everyone who comes through our doors.”


The potential exposure dates to Jan. 18, when a medical team at Forsyth Medical Center performed a procedure on a patient who later tested positive for sporadic CJD. The surgical instruments used during the patient’s surgery were sterilized using standard hospital procedures. However, they were not subjected to the enhanced sterilization procedures necessary on instruments used in confirmed or suspected cases of CJD.


Forsyth Medical Center is currently working with local and state health departments, as well as following guidelines from the Centers for Disease Control and Prevention, to ensure the facility is taking every necessary precaution to prevent a similar occurrence in the future. The hospital is also working with the patients and their families on an individual basis to provide support and care.


About Novant Health


Novant Health is a four-state integrated network of physician practices, outpatient centers and hospitals that deliver a seamless and convenient healthcare experience to our communities. The Novant Health network consists of more than 1,100 physicians and 24,000 employees who make healthcare remarkable at more than 450 locations including 14 medical centers and hundreds of outpatient facilities and physician clinics. Headquartered in Winston-Salem, NC, Novant Health is committed to making healthcare



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