Surgeon-to-patient HCV infections raise questions
Will this be the case that changes national policy?
A Long Island, NY, cardiac surgeon, who unknowingly was infected with hepatitis C for about 10 years, transmitted the virus to at least three patients. This is the first such documented transmission in the United States that did not involve known lapses in infection control practices, and it has prompted new questions about the adequacy of patient protections.
This spring, North Shore University Hospital in Manhasset (NY) began notifying about 3,000 patients that they may have been exposed to hepatitis C during their cardiac surgery. So far, three cases have been confirmed through DNA matching, and another four cases are considered likely to be connected. State health officials are investigating 21 other cases, but they note that an estimated 2% of the U.S. population is infected with hepatitis C and many of those cases may be unrelated to the surgery.
The Centers for Disease Control and Prevention (CDC) does not recommend restricting the practice of health care workers with hepatitis C, and the identification of this cluster has not changed that position.
"At this time, there are no recommendations to restrict the activities of infected health care workers unless transmission is known to have occurred," says Miriam J. Alter, PhD, acting associate director for epidemiology and public health in the division of viral hepatitis at the CDC.
In fact, the surgeon is continuing to practice while using additional precautions, such as double-gloving and blunt sutures. His patients also must provide signed, informed consent. Patients are being tested for HCV before surgery and at a six-week and three-month follow-up.
"It’s unjustifiable to let that surgeon continue to operate after it’s been documented that he infected multiple patients," asserts Janine Jagger, PhD, MPH, director of the International Health Care Worker Safety Center at the University of Virginia in Charlottesville, a needle safety expert who notes that if infected surgeons get cut with their hands deep inside a patient, there is the potential for a much larger blood exposure to the patient than is involved in a typical needlestick.
To Jagger, this case illustrates how unlikely it is to detect nosocomial transmission of HCV without adequate surveillance policies in place. "We need a real national policy on this issue. What we have now is a don’t ask, don’t tell’ policy," she says.
"We need to identify exposure-prone procedures, which would include procedures in which health care workers’ hands are inside a surgical site with sharp instruments," she says. "Then we need to define which pathogen-positive health care workers should not be performing these procedures.
Currently, post-exposure protocol exists only for an injured health care worker. There is no routine post-exposure notification or testing of patients who may be exposed to a bloodborne pathogen by an infected health care worker during invasive procedures, notes Robert Ball, MD, MPH, infectious disease consultant and epidemiologist with the South Carolina Department of Health and Environmental Control in Columbia.
"Why shouldn’t we apply to a patient exposure the same principles we apply to provider exposures?" asks Ball, who is assistant director of the infectious disease division at the University of South Carolina School of Medicine.
First cases appeared in 1993
The first known cases at North Shore occurred almost 10 years ago, in 1993, when two cardiac surgery patients contracted acute hepatitis C. Their cardiologist notified the hospital in 1994, and the hospital checked its records for a relationship between cardiac surgery and other new cases of hepatitis C.
The hospital did not test the surgical team or cardiac patients, but looked for a history of recent cardiac surgery among acute hepatitis C patients from 1991 to 1997. No other cases were found.
"There was nothing to identify a link between those [two infected] patients and the hospital, except for the fact that both were patients there," says Terry Lynam, spokesman for North Shore hospital.
"We had contacted the CDC at the time to try to determine the best course of action," Lynam says. "They pointed out that there was a myriad of possibilities of how the patients had developed the disease. It was possible it was just a coincidence that they were both at the hospital. They could have contracted it outside the hospital.
"At that time, there had never been a reported transmission of hepatitis C by a health care worker to a patient anywhere in the world," he says.
Meanwhile, the cardiac surgeon continued to operate on thousands of patients without realizing that he was infected with hepatitis C. A specialist in valve replacement, he is noted as a proficient and prolific surgeon who has one of the lowest mortality rates in New York state.
There was no further monitoring or investigation related to HCV transmission until 2001, when one of the surgeon’s patients became ill a few months after surgery with acute hepatitis C.
"This was someone who was a regular blood donor and was known to be not infected quite close to the surgery," says Kristine Smith, spokeswoman for the New York State Depart-ment of Health. "It seemed likely it was a nosocomial infection."
By that time, several cases of health care worker-to-patient transmission had been reported around the world. One case of a cardiovascular surgeon in Spain1 is now believed to involve injection drug use, as have at least a couple of other cases in which a health care worker self-injected a patient’s narcotics and reused needles, Alter says.
In a recently reported case, an anesthesiology assistant in Germany transmitted HCV to five patients from a wound on the finger when he performed procedures without wearing gloves.2
An outbreak in 2001 related to a private endoscopy practice occurred when an anesthesiologist reinserted used needles into multidose vials of fentanyl to provide additional anesthetic during surgery.3 In that case, 12 patients contracted HCV from one chronically infected patient within a three-day period.
Investigators in the North Shore case initially looked at multiuse vials in this current cluster, Smith says.
"They were looking for any potential avenue of transmission," she says. "Eventually, it narrowed down to all of the patients having this one doctor. The doctor volunteered to be tested in August of last year [2001]."
After the surgeon learned that he was infected with HCV, blood samples from three patients, including one whose infection dated back to 1993, were sent to the CDC. The Sept. 11 attack and the anthrax threat created delays. Then the CDC reported in March that there was a "high degree of relatedness."
Should HCWs with HCV be restricted?
What restrictions are warranted when a health care worker tests positive for HCV?
The CDC addressed this question for HIV and HBV when concerns arose in 1991. The guidelines call for expert review panels to identify "exposure-prone" procedures and to consider applying restrictions in individual cases. As years have gone by with only one subsequent documented case of provider-to-patient transmission of HIV, occupational health experts have concluded that no procedures are "exposure-prone" for HIV.4
However, the issue is not as clear for HCV. Hepatitis C has a transmission rate of about 0.5% from occupational exposures — slightly greater than that of HIV and less than that of hepatitis B.5,6 The CDC never updated its guidelines to include HCV, and it states simply:
"Currently, no recommendations exist to restrict professional activities of health care workers with HCV infection. As recommended for all health care workers, those who are HCV-positive should follow strict aseptic technique and standard precautions, including appropriate use of hand washing, protective barriers, and care in the use and disposal of needles and other sharp instruments.6
In the aftermath of the North Shore outbreak, the New York health officials relied upon their state policy:
"HIV, hepatitis B virus, or hepatitis C virus infection alone does not justify limiting a health care worker’s professional duties. Limitations, if any, should be determined on a case-by-case basis after consideration of factors that influence transmission risk including inability or unwillingness to comply with infection control standards or functional impairment which interferes with job performance."
With the additional precautions, informed consent, and follow-up of patients, health officials signed off on the surgeon’s continued practice.
"There have been well over 350 surgeries that he’s performed since that time [that he learned of his infection], and there have been no new transmissions," Lynam notes.
Balancing surgeon’s career, patients’ health
That is simply not reassuring enough for Jagger. "If this went through the human investigations committee [as a research project], it would never be approved," she says.
"Can you imagine a research proposal to determine whether an HCV-infected surgeon with a prior history of infecting multiple patients will continue infecting future patients while performing the same exposure-prone procedures?" Lynam asks.
Meanwhile, this case reveals another flaw in the current policy regarding HCV, Jagger says. "The current don’t ask, don’t tell’ policy appears to be aimed at not disrupting the surgeon’s career," she says. "Although the choices are admittedly difficult, the primary concern must be for the patient’s health."
In fact, post-exposure testing, as already mandated by the U.S. Occupational Safety and Health Administration, could benefit both surgeons and patients by allowing them access to effective early treatment, Jagger says.
"We have arrived at a hopeful point in which the discovery of an HCV infection does not necessarily mean a career-ending event for a surgeon," she says. "At this point, it is no longer in the surgeon’s best interest not to know his or her HCV status."
Alter and others have noted that transmission of HCV from health care workers to patients is a very rare event. But how rare? Perhaps, the CDC hasn’t sufficiently tracked transmission, particularly in light of the fact that HCV infection is often asymptomatic, Ball says. "The absence of evidence is not evidence of absence. The lack of data [about HCV transmission] is not evidence of absence of the event."
Ball says he is optimistic that the new questions raised by the North Shore case will have broader impact.
"I think this case is going to be the driver to compel the CDC to revisit and hopefully include hepatitis C in [its] guidelines," he says.
(Editor’s Note: Please take a moment to answer our poll question at your free web site hospitalemployeehealth.com: Should patients be notified whenever there is a potential bloodborne pathogen exposure during surgery?)
References
1. Esteban JI, Gomez J, Martell M, et al. Transmission of hepatitis C virus by a cardiac surgeon. N Engl J Med 1996; 334(9):555-560.
2. Cody SH, Nainan OV, Garfein RS, et al. Hepatitis C Virus Transmission From an anesthesiologist to a patient. Arch Intern Med 2002; 162:345-350.
3. Alter MJ. Presentation to the Healthcare Infection Control Practices Advisory Committee (HICPAC) meeting. Atlanta; June 18, 2002.
4. Centers for Disease Control and Prevention. Recom-mendations for preventing transmission of human immunodeficiency virus and hepatitis B virus to patients during exposure-prone invasive procedures. MMWR 1991; 40(RR-8):1-9.
5. Campbell SR, Srivastava P, Williams I, Alter M, et al. NaSH Surveillance Group. Hepatitis C virus infection after occupational exposure. Infect Control Hosp Epidemiol 2000; 21(2):107.
6. Petrosillo N, Puro V, De Carli G, Ippolito G. Occupational exposure in healthcare workers: An Italian study of occupational risk of HIV and other blood-borne viral infections. British Journal of Infection Control 2001; 2(2):15-17.
7. Centers for Disease Control and Prevention. Recom-mendations for prevention and control of hepatitis C virus (HCV) infection and HCV-related chronic disease. MMWR 1998; 47(RR19);1-39.
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