Statewide Program for Infection Control and Epidemiology/Report of the Month

Report of the Month

REPORT OF THE MONTH, Volume II, Number 3

MAY - JUNE 1998

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from the North Carolina Statewide Program for Infection Control and Epidemiology

NEWS FEATURES
LEVELS OF CONTAMINATION ON SURGICAL INSTRUMENTS AFTER CLEANING

Sterilization of contaminated critical equipment is required to prevent patient-to-patient transmission of pathogenic microorganisms. Surgical instruments are considered critical items since they enter sterile tissue. Because the level of microbial contamination on the object to be sterilized plays such a critical role in determining the efficacy of the overall sterilization process, researchers evaluated the microbial load on used surgical instruments before sterilization (Rutala WA et al. AJIC 1998;26:143-145). The microbial load on used surgical instruments after cleaning was as follows: 36 (72%) instruments 0-10 colony forming units, 7 (14%) instruments 11-100 colony forming units, and 7 (14%) instruments >100 colony forming units. Overall, 30% of the instruments yielded no growth on culture. Organisms contaminating the instruments included coagulase negative staphylococcus 56%, followed by Bacillus 22% and diphtheroids 22%. No other organism contaminated more than 4% of the instruments.

This data demonstrated that most used non-lumened surgical instrument were contaminated with less than 100 relatively non-pathogenic bacteria after cleaning. Cleaning is an essential part of the sterilization process for two reasons. First, it reduces the bioburden and enhances the reliability of the sterilization process. Second, it reduces the levels of residual protein and salt both of which may interfere with the efficacy of sterilization.

FDA APPROVES NEW STERILANTS

Historically the Environmental Protection Agency (EPA) was the organization in the Federal Government which registered new chemical sterilants. There were approximately 40 formulations approved in the United States. Following the agreement between the EPA and FDA that sterilants and high level disinfectants that were intended for use on medical devices would be the responsibility of the FDA, the FDA required all such products to be cleared by the 510 (k) process. As a result there are fewer formulations on the market. Two new liquid chemical sterilants, Sporox® (Reckitt and Colman, NJ) and Peract20TM; (Minntech Corp.) were recently cleared by the FDA for reprocessing medical devices including endoscopes. Peract20TM which consists of 0.08% peroxyacetic acid and 1.0% hydrogen peroxide will also be sold under the trade name Cidex PA (Advanced Sterilization Products). The sterilant claim is 8 hours at 20oC and the high level disinfection claim is 25 minutes at 20oC. However, Olympus does not endorse the use of this product on its endoscopes due to observed internal corrosion (Olympus, Technical Bulletin, April 15, 1998). Sporox® consists of 7.5% hydrogen peroxide. The sterilant claim is 6 hours at room temperature and the high level disinfection claim is 30 minutes at room temperature. Olympus did not find any functional damage to its instruments when Sporox® was used at its recommended concentrations and time for high level disinfection of endoscopes.

LEGISLATIVE/REGULATORY NEWS
NEW CDC PUBLIC HEALTH SERVICE GUIDELINES FOR THE MANAGEMENT OF HEALTH-CARE WORKER EXPOSURES TO HIV AND RECOMMENDATIONS FOR POST-EXPOSURE PROPHYLAXIS

On May 15, 1998, the CDC in collaboration with the National Institute of Health and the Food and Drug Administration released new guidelines for HIV post-exposure prophylaxis (PEP) of HCWs (MMWR Vol. 47 No. RR-7). These guidelines include flow charts for determining risk of transmission and recommended treatment protocols. These guidelines are similar to the CDC's Provisional Recommendations for Chemoprophylaxis after Occupational Exposure (June 7, 1996 MMWR Vol 45 No 22) with three exceptions. One, the addition of an explicit statement that contamination with blood or other potentially infectious body fluids on intact skin is not an exposure. Second, the addition of Nelfinavir (a protease inhibitor) as a first line drug for post-exposure prophylaxis. Third, the time to initiate PEP has been changed from "preferably within 1-2 hours post-exposure" to "treatment should begin within a few hours." The OSHA Bloodborne Pathogen Final Rule requires health care facilities to follow public health service recommendations for HIV post-exposure prophylaxis.

QUESTION OF THE MONTH

Q: Is a consent form required by North Carolina law for HIV post-exposure follow-up of healthcare workers or persons who have a significant blood or other potentially infectious body fluid exposure?

A: Chris Hoke, Deputy State Health Director in the Office of Legal Assistance answered this questions as follows.

1. A consent form is not required to be signed by the source patient for post-exposure HIV/HBV testing.

2. Pre- and post-test counseling with the source patient is required if the source patient is available. Further, the HIV test may be performed on blood already available in the lab when the source is unavailable for pre-test counseling.

3. While it is the attending physician's ultimate responsibility to ensure that counseling is done, it is permissible for other licensed healthcare providers (e.g. RN's) to do the pre-test counseling with the source patient as the designee of the attending physician.

4. For the complete state law regarding post-exposure follow-up see NC Administrative Code 19A.0202 and .0203.

ANNOUNCEMENTS

Statewide Program for Infection Control and Epidemiology (SPICE) is our new name. This new name better describes our services as we continue to provide consultation and education for healthcare facilities in the state.

Dr. Andrew McBride is the new State Public Health Director for North Carolina.

Dr. David Satcher was confirmed as Surgeon General and Assistant Secretary for Health in February 1998. Dr. Satcher was formerly head of the Centers for Disease Control and Prevention.

Dr. Julie Gerbeding is the new director of the Hospital Infections Program at the CDC.

Teleconference on the 1998 Guidelines for Treatment of Sexually Transmitted Diseases will be held on Thursday, July 23, 1998, 9:00 a.m. - 4:00 p.m. Locations are Chapel Hill, Durham, Elizabeth City, Fayetteville, Greenville, Hickory, Lincolnton, Sylva, and Winston-Salem. There is no fee. For more information or to register, call 919-966-4032 or on the WWW go to www.sph.unc.edu/oce/

COURSES FOR THE INFECTION CONTROL PROFESSIONAL

APIC Advanced Course - September 14-17 in Charlotte, NC. (For information, call APIC 202-296-2742.)

NEW COURSE: "Infection Control in Home Health and Hospice" will be held September 28, 1998 at the Omni Chapel Hill Hotel.

"Infection Control Part II: The ICP as an Environmentalist" will be held October 12-16, 1998 at the Holiday Inn in Chapel Hill.

To subscribe to the Report of the Month, send email to spice@unc.edu

Report of the Month is also available on the home page of the Statewide Program for Infection Control and Epidemiology at http://www.unc.edu/depts/spice/

The Statewide Program for Infection Control and Epidemiology (SPICE) is funded by the General Assembly of North Carolina to serve the State. SPICE is not a regulatory agency but provides education and consultation to North Carolina healthcare facilities.

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