It has been nearly three weeks since Forsyth Medical Center disclosed that 18 patients had an exposure risk to Creutzfeldt-Jakob disease – the latest of at least nine incidents at U.S. hospitals this century.
Jeff Lindsay, Forsyth’s president, and its top infectious-disease expert, Dr. Jim Lederer, revealed Feb. 10 that the patients may have been exposed to the rare but fatal degenerative brain disorder during surgeries that occurred from Jan. 18 to Feb. 6. A patient who had brain surgery Jan. 18 was later diagnosed with CJD.
With ashen faces, the Forsyth officials offered a mea culpa for the incident. Lindsay 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.
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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.
If there is any silver lining for the Forsyth hospital patients, it’s that from the other eight incidents, there have been no reported cases of patients exposed to CJD being harmed by disease.
However, it can take months, if not decades, for the symptoms to appear as the prion incubates in the brain.
The Forsyth hospital response, in its timeliness and forthcoming, has been cited by medical analysts and CJD advocates as being appropriate and responsible in publicizing an exposure risk.
Lawrence Muscarella, president of LFM Healthcare Solutions LLC of Colmer, Pa., has written medical articles on the lack of overall disclosure of hospital errors and breaches.
He said Forsyth’s response – which he praised – “demonstrates that standardization for patient notification in the U.S. is lacking, which is problematic and warrants corrective actions.”
Since Feb. 10, Forsyth and Novant officials have been silent about the CJD incident. They have not provided answers to a series of medical and logistical questions submitted by the Winston-Salem Journal.
Novant spokeswoman Caryn Klebba said an update on its internal investigation could be provided the week of March 17.
Some downplay risk
Forsyth’s incident initially captured the attention of regional and national media outlets.
“The psychological impact is hard to overestimate,” Dr. Sanjay Gupta said on a Feb. 11 CNN appearance.
“You just don’t know if you have it or not, and it could take years for the symptoms to develop. That’s the really tough part for these 18 patients.
“Very, very low chance they have it. But psychologically, they have to live with that not knowing for a long time.”
Yet, some hospitals have responded to their CJD exposure incident by either downplaying the risk to patients or by conducting a rapid internal investigation.
For example, a patient at the University of Wisconsin Health Center had neurosurgery for a brain tumor June 11, 2009.
The hospital said it received a confirmed diagnosis of CJD for the patient on July 20, 2009, after an earlier test did not detect CJD. By that time, 53 neurosurgical patients were exposed to the same surgical equipment, which was not sterilized to enhanced standards. The age range for the patients was 3 to 83.
“We are confident that we have followed standard procedures and followed the best procedures recommended to us,” Dr. Carl Getto, vice president of clinical affairs, said in a statement. “Our processes are exactly what you should expect from a quality hospital.”
Getto said during a July 24, 2009, press conference that the affected patients “should not have cause to feel upset, worried or concerned” because the exposure risk is “virtually nonexistent.”
“There is no reason for fear, being scared, changing their daily activities.”
Greenville (S.C.) Health System announced July 31, 2012, that 11 patients potentially had been exposed to surgical equipment used on a patient later diagnosed with CJD.
Four days later, Tom Diller, the system’s vice president for quality and patient safety, released a video statement in which he said “our internal investigation revealed that our policy regarding how to handle CJD cases is very good and that it was followed. Our surgical instrument sterilization process is also very good and it was followed.”
“Thus, no patient safety error occurred and no mistakes were made. Our physicians, who are familiar with CJD, could not have made the diagnosis at the time of the original surgery, and thus had no reason to isolate those instruments at that time.”
Diller pronounced that “in conclusion, our investigation is complete. Our policies and procedures meet all CDC recommendations.”
Case at Emory
A case in south Wales demonstrates how long it may take for an exposure risk to be recognized and acknowledged publicly.
A patient initially underwent surgery in 2007. Two years later, following another surgical procedure, the hospital determined the patient was at high risk for contracting CJD.
Officials at four hospitals determined the surgical equipment had been used on 38 other patients during the two-year period.
However, the 38 patients were not informed of their exposure risk until March 2011, according to a BBC News report. The article said a United Kingdom CJD incidents panel was informed of the exposure risk in 2009. The panel did not recommend that the patients be told until February 2011.
In October 2004, at least 516 patients -- 98 brain or spinal surgery patients and 418 other non-neurosurgical patients – potentially were exposed to CJD via surgical equipment at Emory University Hospital in Atlanta.
At least 17 patients sued the hospital in the spring of 2006, about 18 months after the hospital disclosed the incident. The plaintiff accused the hospital system of medical malpractice, breach of fiduciary duty, reckless infliction of emotional distress and breach of informed consent.
Emory responded to the lawsuit by denying all of the allegations, according to a March 2006 article on the AccessNorthGeorgia website. “There are no cases in the medical literature of CJD having been transmitted following the routine measures of surgical instrument sterilization that we employed,” Emory spokesman Ron Sauder said at that time.
After nearly five years of litigation and depositions, the hospitals and the 17 patients reached a confidential settlement in 2011.
Muscarella said he estimates that as many as 90 percent of hospital errors and safety breaches are not made public. He said in many instances a whistleblower likely played a role when a breach is acknowledged.
“The argument that ‘fear and worry’ could accompany disclosure of a breach to affected patients may be used, and often is, by a health-care facility, agency or organization to conclude that these patients not be told of a reprocessing or other type of infection-control error,” Muscarella said.
“But not to be overlooked, this is a classic example of a potentially biased risk assessment, due to a conflict of interest.
“The health-care facility or agency rendering this conclusion benefits, by minimizing the likelihood of it being exposed to ligation, by not informing patients of the breach,” he said.
rcraver@wsjournal.com (336) 727-7376
Creutzfeldt-Jakob exposure
There have been at least nine high-profile cases in the United States in the past 14 years where surgical equipment, mostly for neurosurgery, was used on patients after the equipment was first used on a patient later diagnosed with the disease.
The equipment appears to have been sterilized by standard procedures, but not to enhanced standards recommended by the World Health Organization when exposed to CJD. WHO officials recommend destroying the equipment when practical and cost effective.
• In 2000, six patients at Exempla Saint Joseph Hospital in Denver.
• In October 2000, eight patients at Tulane Hospital and Clinic in New Orleans.
• In June 2002, the University of Pittsburgh Medical Center Presbyterian announced patients might have been exposed to CJD from April 2001 to April 2002. Media reports said the exposure level could have been up to 4,000 patients.
• In October 2004, at least 516 patients - 98 brain or spinal surgery patients and 418 other non-neurosurgical patients - at Emory University Hospital in Atlanta.
• In January 2006, 155 patients at McKay-Dee Hospital in Odgen, Utah.
• In July 2009, 53 patients at University of Wisconsin Hospital in Madison, Wis.
• In July 2012, 11 patients at Greensville Health System in Greenville, S.C.
• In September 2013, eight neurosurgical patients at Catholic Medical Center in Manchester, N.H. The N.H. Department of Health and Human Services said another five patients in Connecticut and Massachusetts were exposed.
• Jan. 18-Feb. 6, 2004: 18 patients at Forsyth Medical Center.
Also, there were exposure risk incidents in August 2007 involving 43 patients in Auckland, N.Z., and in 2007-09 involving 38 patients in Wales.
Sources: Hospital press releases; Scientific American; New England Journal of Medicine; media reports