Novant: Three more may have been exposed to disease CJD
Novant: Three more may have been exposed to disease
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Related: 18 patients exposed to deadly disease at Forsyth Medical
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Posted: Thursday, April 17, 2014 9:02 am
Novant: Three more may have been exposed to disease
By Richard Craver Winston-Salem Journal news-record.com
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
NOVANT HEALTH NOTIFIES PATIENTS OF POSSIBLE EXPOSURE TO CREUTZFELDT-JAKOB
DISEASE
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
Tuesday, February 11, 2014
Novant Health Forsyth Medical Center Information on potential CJD exposure
Sunday, April 06, 2014
SPORADIC CJD and the potential for zoonotic transmission there from, either
directly or indirectly via friendly fire iatrogenic mode, evidence to date
Tuesday, April 01, 2014
Questions linger in U.S. CJD cases 2005, and still do in 2014
Sunday, March 09, 2014
A Creutzfeldt-Jakob Disease (CJD) Lookback Study: Assessing the Risk of
Blood Borne Transmission of Classic Forms of Creutzfeldt-Jakob Disease
FDA TSEAC CIRCUS AND TRAVELING ROAD SHOW FOR THE TSE PRION DISEASES
Friday, February 14, 2014
Creutzfeldt-Jakob disease (CJD) biannual update (February 2014), with
briefing on novel human prion disease National CJD Research and Surveillance
Unit NCJDRSU
TSS
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2:53 PM
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