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Infection control and quality professionals dealing with the fallout of an unsuspected case of Creutzfeldt-Jacob disease (CJD) credit their surgical-instrument-tracking system for rapidly identifying exposed patients and preventing additional exposures. In light of the case, however, they have amended their policy to ensure surgical instruments used on certain patients are quarantined until CJD can be ruled out. (See policy, p. 123.)
Last year, a patient with no apparent neurological symptoms of CJD came to Exempla Saint Joseph Hospital in Denver for a brain biopsy to rule out vasculitis. Three weeks later, the pathology report came back confirming CJD.
Unfortunately the instruments used on the patient had been reused on six subsequent patients in the interim between the biopsy and the diagnosis. Those had to be considered possible exposures because traditional sterilization methods may not effectively kill CJD left on instruments. More patients could have been exposed but for a surgical-instrument-tracking system that enabled clinicians to rapidly identify the subsequent cases.
"The tracking of the surgical instruments was huge," says Colleen Casaceli, BSN, MPH, CIC, infection control coordinator at Exempla. "That was so helpful because it really did narrow down the number of individuals at risk. Not everybody does that, so that would be a serious recommendation to take into consideration." The tracking system includes an inventory sheet that is filled out at the time each pack of surgical instruments is assembled. Each of those inventory sheets and packs have a unique number.
"When that pack is used for a surgical procedure, the number from that pack is put into the patients chart so we know specifically what pack has been used for what patient and what procedure," says Kristin Burkett, senior director of quality at Exempla. "So if we have to go back, like in this case, and pull the patient record for a patient diagnosed with CJD, we could identify what specific packs were used in that surgery"
While the instrument-tracking policy was already in place, the case underscored a new policy was needed for patients with unsuspected CJD. The surgical schedule now is screened daily to look for brain biopsies slated for patients that do not have a confirmed diagnosis.
"If the surgeons are unclear about what they are looking for or are doing the biopsy to get an idea what is going on with the patient, we treat that as a potential CJD," Burkett says.
The instruments used in the case are then quarantined until a pathology report is completed to confirm or rule out CJD. "If it is something else, we can sterilize and put the instruments back into circulation," Burkett says.
If the patient is discovered to have CJD, however, the instruments are destroyed. While public health authorities have outlined a sterilization protocol, there are questions about whether instruments will be damaged in attempting to kill CJD cellular material.
"Our sterile-processing people advised us that those sterile processing techniques actually destroy the instruments," Casaceli adds. "So our policy is really written that when we identify a CJD case on whom instruments have been quarantined, we are going to go ahead and incinerate those instruments. That eliminates any risk of potential use on another individual or of compromising the integrity of the instruments."
That does not mean that everything in the OR needs to be incinerated, however, Burkett emphasizes. "I’ve had a couple of calls from hospitals where they think that everything that is in the OR needs to be taken out of service," she says. "That is not the case. They are overreacting to the facts about this type of disease and how it is transmitted. It is specifically the instruments that have contact with spinal fluid or dura mater. That really limits the number of instruments that need to be quarantined."
In such a case, use as many disposables as possible to begin with, Casceli adds. "Our bits and blades and such are disposable anyway," she says. "Those are the things that are going to have the greatest [patient] contact."
WHO outlines three cleaning protocols
For ICPs who do not have such options and must reprocess instruments, the World Health Organization in Geneva has developed a protocol.1
The following approaches can be used to reprocess heat-resistant instruments that come in contact with high-infectivity tissues (brain, spinal cord, and eyes) and low-infectivity tissues (cerebrospinal fluid, kidneys, liver, lungs, lymph nodes, spleen, and placenta) of patients with suspected or confirmed CJD. The three alternatives are listed in order of more to less severe treatment.
1. Immerse in 1N sodium hydroxide (NaOH) and heat in a gravity displacement autoclave at 121 C for 30 minutes, clean, rinse in water, and subject to routine sterilization.
2. Immerse in 1N NaOH or sodium hypochlorite (20,000 ppm) for one hour, transfer instruments to water, heat in a gravity displacement autoclave at 121 C for one hour, clean, and subject to routine sterilization.
3. Immerse in 1N NaOH or sodium hypochlorite (20,000 ppm) for one hour, remove and rinse in water, then transfer to open pan, and heat in a gravity displacement (121 C) or porous load (134 C) autoclave for one hour, clean, and subject to routine sterilization.
1. World Health Organization Department of Communi-cable Disease Surveillance and Response. WHO Infection Control Guidelines for Transmissible Spongiform Encephalo-pathies: Report of a WHO Consultation. Geneva; 1999.