Special Report
Infection control tapped for critical role in xenotransplants
Infection control must be part of this’
While seen as appropriate and even empowering, the designation of infection control professionals as critical members of xenotransplant teams in new draft federal guidelines raises a myriad of issues that will have to be resolved as science fiction becomes medical fact.
The draft guidelines by the U.S. Public Health Service include a section on hospital infection control that outlines measures to protect both transplant patients and health care workers from infections following xenotransplants.1 For example, the guidelines call for creation of a nosocomial exposure log to document needlesticks and other incidents involving exposures to health care workers from xenotransplant patients recipients of animal organs or tissue that may harbor retroviruses from their animal donors.
’There will be a level of risk to health care workers exposed to body fluids and tissues of patients following the xenotransplant, and that level of risk at present is undefinable,” says Louisa Chapman, MD, medical epidemiologist in the retrovirus diseases branch at the Centers for Disease Control and Prevention. ’It may be very low it may be negligible but until we can say that the risk of infection to the recipient is zero, we can’t say that the risk of further transmission to health care workers is zero.”
The roles of hospital epidemiology and occupational health were emphasized in part in the guidelines to avoid later ’curbside consultations” where ICPs may be asked to address issues only as they arise.
CDC: ICPs should have significant voice’
’These people should not be consulted on the spot to make a difficult decision without prior opportunity to educate themselves and think in a systematic way on the issues,” Chapman says. ’They need to be on the team from the beginning. They need to have the opportunity beforehand to provide guidance and have a significant voice in occupational health issues and whether they feel appropriate isolation precautions are used.”
The multidisciplinary xenotransplant team is a good concept, but should be expanded to include members of the local health department both in areas where such programs are undertaken and in the communities to which patients return, says Angela Goetz, MNEd, infection control practitioner at the VA Medical Center in Pittsburgh, a facility that performs a high volume of human-to-human liver transplants.
’Because there is the potential for release of infectious agents into the community, I think they need to know exactly what is going on,” she says.
While the CDC plans to compile a national database on xenotransplant recipients, there is concern that follow-up could be lost on xenotransplant recipients that may eventually be admitted to community hospitals for other reasons. How such patients should be handled on readmissions, and whether that would mean community hospitals would have to be ready to gear up to meet the xenotransplant education, documentation, and infection control requirements are questions that will have to be answered as such programs are refined.
’The reality that this doesn’t even touch upon is when these people are stabilized and they go back to their homes, and they break a leg or get a severe laceration,” says Patricia Grant, RN, BSN, CIC, infection control coordinator at Parkland Memorial Hospital in Dallas. ’They are not going to be care-flighted’ back five states away where they had the transplant. They will go to their local facility.”
While only major teaching and research institutions are expected to be initially involved in such programs, more hospitals and ICPs may eventually have to address such questions if xenotransplantation continues to be perfected as a medical technology and gains more widespread acceptance. For example, human transplants were once under the purview of only a few cutting-edge programs.
’Every university and their brother is doing transplants now,” Goetz says. ’As you train your residents and your fellows and they go out and want to develop their careers that is exactly what will probably happen [with xenotransplantation].”
Isolation, HCW issues
The guidelines call for a general adherence to standard precautions to deal with xenotransplant patients, leaving decisions about more elaborate isolation measures on the local level to be made on a case-by-case basis. That is well and good, but health care workers’ historical lack of compliance with infection control measures sets a disturbing precedent.
’Strict adherence to standard precautions is a very broad assumption, and one that I do not accept,” Goetz says.
And as a practical matter, how will decisions be made to adhere to the recommendation that isolation precautions should be continued until a xenogeneic infection has been proven or resolved, when one of the main concerns for such patients is unknown retroviruses that have long incubation periods, Grant asks.
The occupational health issues are no less complex, as the guidelines recommend drawing baseline blood samples from the health care workers involved and educating them about the risk associated with care of such patients.
’You’re removing all of the natural barriers; it’s a direct transplant and you are going to immune-suppress the patient,” Grant says. ’Anything is possible. We just don’t know. With that in mind, the forethought of archiving health care worker’ specimens is a wise one. ’
Implementation is another question, however, if the full circle of workers who may have some contact with the patient are indeed to have blood drawn and be educated regarding risk particularly since it could not be determined with certainty beforehand how a new pathogen may be transmitted.
’Just think of all of the people that touch one patient during one hospitalization,” Grant says. ’The way this is written is that anyone phlebotomy, respiratory therapists, social workers who cares for that patient and has the potential to be exposed in an occupational incident would have to have specimens drawn and archived. ’
Likewise, efforts would likely have to be made to try to exclude immunocompromised workers from caring for such patients, Goetz adds, opening up issues of confidentiality and infection risks that have proven difficult in the care of tuberculosis patients.
’I would have the same team of nurses taking care of these patients, just in case there is something that they are being exposed to,” Goetz says. ’I would want nurses and other health care workers to volunteer and then keep that group. In case something does happen, you have at least confined it to a small group.”
Potential for precedent
Beyond the exotic nature of addressing the infection control aspects of unknown pathogens and unquantified risk, the xenotransplant guidelines particularly as they apply to occupational health issues have the potential to become codified into regulations, Grant says.
Few could have predicted a decade ago how ingrained the Occupational Safety and Health Administration’s bloodborne pathogen standard would be in hospitals, she notes. Likewise, the guidelines could set a precedent in assigning research institutions responsibility for the lifelong surveillance of xenotransplant recipients.
’The surveillance and isolation issues alone, I would think, would require massive increases in infection control resources,” she says. ’If you were to implement this in its pure form and in all of its vagueness, you would almost have to have a team that did nothing but do this even if you only had four or five of these transplants a year.”
Indeed, if xenotransplantation fulfills the promise of its advocates, lifelong surveillance essentially dependent on the patient to return voluntarily for check-ups would be the reality for an increasing number of recipients who are enjoying longer survival periods as the science improves.
’One wonders how that is going to be funded and structured,” says William Schaffner, MD, infectious disease professor and chairman of the department of preventive medicine at Vanderbilt University in Nashville, TN. ’The wording is that institutions have to follow them for life, but institutions don’t do anything it is the people in them. And if the personnel change within an institution, I’m not entirely sure how you would structure this to be able to make the commitment to follow human beings for life.”
Overall, however, such details will be worked out in good faith by medical centers and the government agencies providing the oversight, he says. By acknowledging some level of risk and establishing prevention measures, the overall thrust of the guidelines reflects the growing awareness of the issue of emerging infections, Schaffner says. It may also reflect lessons learned with allografts, which expanded as a science in the absence of a similar national debate on infectious disease risk and eventually saw transmission of HIV and other pathogens to transplant recipients.
’That was something that infection control had to catch up with, because it was in many ways disorganized and local,” he says. ’It took us a while to realize we had a role in providing advice, oversight, and even some regulation on organ transplants. Experience has informed the committee that put these regulations together and they have learned from it. It is clear that infection control must be part of this.”
Reference
1. Department of Health and Human Services. Draft Public Health Service guideline on infectious disease issues in xenotransplantation. Fed Reg Sept. 23, 1996; 49,919-49,932.
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