The disclosure in September concerning a New Hampshirehospitalpatientwhodiedof Creutzfeldt- Jakob Disease (CJD) this past spring reaffirms the need for continuing and enhanced research in disease monitoring and disinfection techniques
within hospital environments. CJD is a rapidly progressive
neurodegenerative disease that is always fatal within one year
of onset—there is no cure. The disease can only be diagnosed
positively through autopsies. While relatively rare, the number of annual deaths associated with CJD in the U.S. has risen
steadily from 250 in 2000 to more than 350 in 2009.
Standard hospital disinfection techniques cannot eradicate the prion that causes CJD from surgical instruments. As a result, 15 patients
were possibly exposed to CJD—eight in New Hampshire, five in Massachusetts, and
two in Connecticut. The Massachusetts and Connecticut patients were all treated
using the same Medtronic guided imaging navigation system and associated surgical
tools used in the New Hampshire surgery. Hospitals often share these high-cost neurosurgery tools on a rental basis, explaining the multi-state CJD exposure.
The CDC and the World Health Organization (WHO) have established guidelines
for reprocessing surgical instruments potentially contaminated by CJD. These guidelines
were derived from in vitro inactivation studies using brain tissues or tissue homogenates,
both of which pose substantial challenges to any sterilization process. Obviously, destruction of the surgical devices is the safest and most unambiguous method, but often the
most impractical and always the least cost-effective. According to the CDC, one of the
three most stringent chemical and autoclave sterilization methods outlined in Annex III
of the WHO guidelines should be used to reprocess heat-resistant instruments that come
in contact with the highly infectious tissues of patients with suspected or confirmed CJD.
Since these methods are extremely harsh and potentially corrosive, users should consult
with the device manufacturers as to their instruments’ tolerance of extended exposure to
heated, concentrated sodium hypochlorite or sodium hydroxide—the common cleaning
agents recommended in the WHO guidelines.
Following the New Hampshire CJD announcement, the Joint Commission, a
non-profit hospital accreditation organization ( www.jointcommission.org), reiterated guidelines urging hospitals to have a high degree of suspicion about CJD even
when diagnosis is not confirmed and to follow CDC/WHO guidance on sterilization
or disposal of surgical tools. Mark Chassin, President/CEO of the Joint Commission,
stated that too many hospitals experience serious safety failures as routine and inevitable parts of their daily work. He emphasized a framework for major changes involving leadership, safety culture and robust process improvement. The process improvement changes recommended include a combination of Six Sigma, Lean, and change
management in order to make far greater progress toward eliminating patient harm.
Clearly, most of the safety methodologies recommended by the CDC, WHO,
or the Joint Commission were not in place during the initial New Hampshire CJD
surgery, otherwise the 15 patients would not have had to be informed of their deadly
disease risk nearly six months after their possible exposure.
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