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People, Places, Processes & Products that Influence the Supply Chain

 
 

INSIDE THE CURRENT ISSUE

February 2010

CS Solutions

Questions can be sent to:jakridge@hpnonline.com
called in to Jeannie Akridge at HPN:(941) 927-9345 ext.202 or mailed to:
HPN CS Questions, 2477 Stickney Point Road, Suite 315B, Sarasota, FL 34231
Names and hospital identification will be withheld upon request.

Instruments used on CJD patients; failed internal chemical integrators

by Ray Taurasi

QWe are updating our policies, and I’m wondering if you can tell me how instruments that have been used in a case with Cruetzfeldt-Jakob disease should be taken care of, from the minute they come into the decontamination room up until they are sterilized.

AProcedures should be in place and clinicians instructed to segregate instruments contaminated by High Risk, Low Risk and No Risk body tissue from CJD patients.

• High Risk Tissue contamination would be those instruments which have come in contact with spinal cord, brain matter, and or eye tissue.

• Low Risk Tissue contamination includes devices which have been in contact with cerebrospinal fluids, kidney, spleen, liver, lungs, or lymph nodes.

• No Risk tissue includes intestinal tissue, blood, serum, leukocytes, adrenal gland, thyroid gland, peripheral nerve tissue, and bone marrow.

As in all cases, soiled and contaminated instruments should be kept moist to prevent the coagulation and drying of organic matter, blood, proteins and other body fluids. It is also very important that soiled instruments be cleaned as soon as possible. OSHA protocols relative to the safe handling and transportation of bio hazardous materials must be enforced including the application and appropriate use of PPE.

In known CJD cases medical devices which have come in contact with or are contaminated by high risk tissues must be carefully handled from the point of use through the contamination process. Non complex basic instruments which can be cleaned effectively to remove tissue should then be sterilized at 134°C for a minimum of 18 minutes in a pre vac sterilizer or in a gravity displacement sterilizer at 121°C - 132°C for one hour.

Complex medical devices, e.g. those with movable or multiple parts which can not be disassembled, cleaned effectively or pose a challenge to the cleaning process should be discarded. Alternatively such devices can be placed in a container of water or phenolic solution to prevent the adherence of organic soil and decontaminated by a pre vacuum steam sterilization process at 134°C for a minimum of 18 minutes or at 121°C - 132°C in a gravity displacement sterilizer (solution should be removed prior to sterilization) or the device may be soaked in a solution of NaON (lye) for one hour. The device may then be cleaned, wrapped and terminally sterilized in the conventional manner. It is important to note that NaON solutions should not be placed in a sterilizer as this would pose a risk to employee safety, and would be extremely damaging to instruments and the sterilizer. Power equipment such as saws and drills should not be used in procedures where they are likely to be contaminated by high risk tissue. These devices by design are difficult to clean and too expensive to discard.

The safest method for ensuring that there is no risk of residual CJD infectivity on contaminated instruments and other materials is to destroy them by incineration. Disposable instrument sets appropriate for use on CJD procedures are commercially available and should be used accordingly.

Medical devices and surgical instruments contaminated through contact with low risk or no risk tissue can be reprocessed, cleaned, decontaminated, disinfected and sterilized using conventional protocols. As is the case in all matters of reprocessing and sterilization the device manufacturer’s instructions for care, handling and reprocessing should be followed. A tracking system - either a computerized or manual system - should be in place which could identify medical devices used in high risk cases and the patient such devices were utilized on. Tracking information should also include the date and type of procedure performed and the surgeon’s name.

QI am the peri-operative director in a large academic medical center. Over the past week we have encountered several sterile instrument sets in which the internal indicators/integrators have not changed; however the external tapes all changed. The inconsistency in the two indicators is unacceptable. It infuriates and troubles me that the CS department is so careless and does not have better QA processes in place to prevent such incidents from occurring. Relationships between the OR and CPD are already strained and this situation has further eroded my confidence in the CPD management competence. How would you suggest I best deal with this situation?

AInternal chemical integrators are placed inside of a package to monitor and confirm that the sterilant and appropriate sterilization parameters where achieved within the package. There is no way that the CPD could ascertain the results of the internal CIs without opening the sterile package. You must understand that the external indicators which are traditionally a class one indicator merely allow for the identification of goods which have gone through a sterilization process from those that have not. Generally they do not ensure the achievement of sterilization parameters. The Central Processing department relies on the sterilizer mechanical records, BIs and test packs for QA of the sterilizers proper functioning. The fact that your staff observed the failed internal integrators is a good thing, it indicates that the QA process was working and identified a potential processing failure and prevented the use of questionable products being used in patient care.

When such incidents occur there is no value or purpose in placing blame or displacing anger on the CPD staff. There are many potential reasons why a CI may fail including mechanical, processing and human errors or even a faulty CI. CPD and OR management should work collaboratively to find the source of the problem and to resolve the issue. I don’t think you should be so quick to accuse CPD of carelessness or inferior performance. It would be another story if your CPD manager didn’t take the matter seriously or failed to investigate and correct the source of the problem. If this was or is the case then you should of course elevate the situation to the appropriate administrative resource, infection control and risk management for resolution and action.

Ray Taurasi is Eastern Regional Director of Clinical Sales and Services for Healthmark Industries. His healthcare career spans over three decades as an Administrator, Educator, Technologist and Consultant. He is a member of AORN, AHA, SGNA, AAMI and a past president of IAHCSMM and has served on and contributed to many national committees with a myriad of professional organizations, manufacturers, corporations and prestigious healthcare networks. Taurasi has been a faculty member of numerous colleges teaching in the divisions of business administration and health sciences. In addition to this column he has authored several articles and has been a featured speaker on the international scene.