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CONTENTS:
NEWS FEATURES
Answers to Questions about Smallpox Vaccine Administration for Hospitals
REGULATORY/LEGISLATIVE
What Happened to the Amended NC Sanitation Rules?
QUESTION OF THE MONTH
Probe Use in Surgical Procedures
NEWS AND ANNOUNCEMENTS
COURSES FOR THE INFECTION CONTROL PROFESSIONAL
NEWS FEATURES
Answers to Questions about Smallpox Vaccine Administration for Hospitals
The following represents a review of the risks and benefits of vaccinia vaccination. This is provided for information purposes by SPICE and does not represent an official statement by the CDC, FDA, or state health department. Providers should be knowledgeable regarding the information provided by the FDA and CDC. The smallpox vaccination program is still being developed and there are likely to be changes in the future.
Question 1. Which healthcare workers will be recommended to receive smallpox immunization?
The most recent statement by the ACIP recommended immunization of a core group of healthcare personnel that includes infection control professionals and the hospital epidemiologist. An example team includes 40 health care workers per hospital: 15 emergency department physicians and nurses, eight intensive care unit (ICU) nurses for adult patients, eight pediatric ICU nurses, a dermatology consultant, four respiratory therapists, four radiology technicians, two engineers and selected staff from the security and housekeeping departments. In order to have a core group of 40 available, it would be necessary to vaccinate up to 100 people to allow for vacations and backup personnel.
It is unclear why occupational health personnel were not included in the ACIP recommendations. It is likely that ICP were included because they were considered the likely persons to provide immunizations (rather than occupational health personnel) to healthcare personnel in the advent of the use of smallpox as a biologic weapon. Also ICPs would be involved in interacting with potential cases of smallpox to determine need for isolation, assess possible source of exposure, and assess possible healthcare-associated exposures.
Question 2. What is the risk of vaccinia immunization?
The risks of vaccination are listed in the table. In a recent study of vaccinia vaccination ~1/3 of persons became ill enough to miss either work or school.
|
Reaction |
Primary Vaccination |
Re-vaccination |
|
Inadvertent inoculation |
1/1,700 |
1/24,000 |
|
Generalized vaccinia |
1/5,000 |
1/111,000 |
|
Eczema vaccinatum |
1/26,000 |
1/333,000 |
|
Progressive vaccinia |
1/667,000 |
1/333,000 |
|
Post vaccinial encephalitis |
1/80,000 |
1/500,000 |
|
Death |
1/million |
0.25/million |
Question 3. What are the contra-indications to vaccinia immunization?
Contra-indications to vaccinia immunization include the following: a history of atopic dermatitis or eczema irrespective of disease severity or activity; pregnancy; altered immunocompetence such as leukemia, lupus, lymphoma, generalized malignancy, solid organ transplantation, or therapy with alkylating agents, antimetabolites, radiation, or high-dose corticosteroid therapy (>20 mg/day prednisone for >2 weeks); HIV infection. Under the current guidelines, children under age 18 are not to receive the immunization.
Question 4. What are the risks to household contacts of vaccinees?
A 10-state survey in 1968 reported that the rate of transmission to contacts was 27 infections/million vaccinations; 44% of those contact cases occurred among children aged <5 years. Approximately 60% of contact transmission resulted in inadvertent inoculation of otherwise healthy persons. Approximately 30% of the eczema vaccinatum cases were the result of contact transmission. Eczema vaccinatum may be more severe among contacts than among vaccinated persons.
Prevention of transmission to contacts included keeping the primary inoculation site covered and avoiding direct skin contact between contacts and active skin lesions.
Question 5. Why are household contacts not included in the current plans for vaccinia immunization?
The current plan for nonmilitary personnel includes only healthcare providers and emergency responders. Healthcare workers who have household contacts at risk for adverse reactions (see contra-indications above) will not be eligible for vaccine. Healthcare workers being vaccinated can have a child at home but the child should not have any of the above contra-indications.
Question 6. How should vaccinated healthcare workers be managed?
The site of the vaccination should be covered with gauze. A semi-permeable dressing should be placed over the gauze. The site should be covered until the scab separates. Designated, vaccinated staff should assess dressings for all vaccinated healthcare workers daily for local reactions and vaccine take.
The ACIP does not believe that healthcare workers need to be placed on leave because they received a smallpox vaccination unless they are physically unable to work due to systemic signs and symptoms of illness, extensive skin lesions that cannot be adequately covered, or if they do not adhere to the recommended infection control precautions.
Vaccination should be phased in to ensure adequate staffing of the healthcare facility.
Question 7. Will acceptance of the smallpox vaccine be voluntary?
Currently, the CDC and State plan to provide the vaccine only to volunteers. However, individual hospitals will need to develop their own recommendations. Only immunized staff should used to provide care for patients with suspected smallpox. In the advent of a large bioterrorist attach with smallpox virus, it is likely that all healthcare providers will need to provide care for victims. Nonimmunized healthcare providers can receive post-exposure prophylaxis with vaccine.
Question 8. Will we take the smallpox vaccine?
The decision to accept immunization is based on individual perceptions of risks and benefits. Dr. Weber, Medical Director for Epidemiology, Occupational Health and Safety for UNC Health Care System, will be vaccinated since he will providing vaccine to UNC Health Care System employees.
REGULATORY/LEGISLATIVE
What Happened to the Amended North Carolina Sanitation Rules for Hospitals, Nursing and Rest Homes and Other Institutions?
The Amended North Carolina Sanitation Rules for Hospitals, Nursing and Rest Homes and Other Institutions have been delayed until at least March 1, 2003, so that a field test of the amended rules and grading system can be completed. The purpose of the field test is to identify any costs the facilities covered by the rules may incur as a result of the amendments and make any needed changes to mitigate financial impact.
QUESTION OF THE MONTH
Probe Use in Surgical Procedures
Q: Our surgeons want to know if they can use dopplers or ultrasound probes originally designed for non-invasive use in surgical procedures. These non-sterile medical devices are covered by a sterile plastic sheath (i.e., probe cover) and placed directly on heart, liver and other vital organs during surgery. Is this acceptable practice and how should reprocessing of the device be done?
A: While the use of sterile probe covers is acceptable to prevent gross contamination of the medical device, current CDC guidelines require that all critical devices (i.e., medical devices that touch sterile tissue) be sterilized between patients. Any FDA approved sterilization method is acceptable (i.e., steam, ethylene oxide, or hydrogen-peroxide plasma). It is recommended to check with the device manufacturer to determine what the appropriate sterilization process is that will be compatible with the device. Probe covers have been documented to fail and therefore do not adequately prevent possible person-to-person transmission of bloodborne pathogens (e.g., HIV, HBV, HCV) and other potential pathogens (e.g., Gram-negative bacilli).
Editor's note: An informal survey found several facilities not reprocessing probes per Guidelines Recommendations. It is suggested that infection control professionals check with their institutions' surgical service to determine compliance.
ANNOUNCEMENTS
Guideline for Hand Hygiene in Health-Settings was published in the MMWR October 25, 2002. The guideline along with promotional materials and fact sheets is available at:
http://www.cdc.gov/handhygiene
November 15, 2002. The Food and Drug Administration (FDA) announced a nationwide alert concerning all injectable drugs prepared by Urgent Care Pharmacy of Spartanburg, South Carolina, based on the lack of assurance that their products are sterile. Non-sterility of injectable products can represent a serious hazard to health that could lead to life-threatening injuries and death. FDA inspection of Urgent Care's facility revealed the firm failed to have adequate controls to ensure necessary sterility, including the absence of appropriate testing for potency and sterility prior to distribution. Urgent Care injectables are labeled as URGENT CARE PHARMACY 2500 WINCHESTER PLACE , STE. 106, SPARTANBURG, SC 29301, 800-692-8982. Consumers, physicians, and health care workers are urged to examine their drug supplies for any Urgent Care injectable products and immediately discontinue their use. Users should also notify FDA of any complaints or problems associated with these products.
http://www.fda.gov/bbs/topics/ANSWERS/2002/ANS01171.html
On November 7, 2002, the U.S. Food and Drug Administration announced that it had approved a new rapid HIV diagnostic test kit that provides results with 99.6 percent accuracy in as little as 20 minutes. Using less than a drop of blood collected, this new test can quickly and reliably detect antibodies to HIV-1, the HIV virus that causes infection in most cases in the U.S. Unlike other antibody tests for HIV, this test can be stored at room temperature, requires no specialized equipment, and may be considered for use outside of traditional laboratory or clinical settings. The newly approved HIV test is called The OraQuick Rapid HIV-1 Antibody Test, manufactured by OraSure Technologies, Inc., Bethlehem, Pennsylvania.
http://www.fda.gov/bbs/topics/NEWS/2002/NEW00852.html
September 12, 2002. The Food and Drug Administration (FDA) announced that Baxter Healthcare Corporation notified dialysis centers that certain blood tubing used with Baxter's Meridian dialysis machines may possibly be linked to five patient deaths and two injuries. These occurred at two kidney dialysis centers in late August. Although the cause of the deaths had not yet been determined, Baxter on September 6 notified hemodialysis centers that it was exploring the possibility that the patients' hemodialysis treatments may have used the same model dialysis machine and bloodline set. Baxter told customers to immediately discontinue use of certain models of Medisystems blood tubing in conjunction with Meridian dialysis machines and use other Medisystems blood tubing instead. Further details can be obtained from Baxter's Postmarket Surveillance Group at 1-888-736-2543, option 3.
September 23, 2002 - The CDC announced that the CDC
Smallpox Response Plan and Guidelines added an important addition to
smallpox preparedness efforts-a comprehensive annex titled "Smallpox
Vaccination Clinic Guide." This new section-part of the upcoming Version 3
of the CDC Smallpox Response Plan and Guidelines-describes the operational
and logistical considerations associated with implementing a large-scale
voluntary vaccination program in response to a confirmed smallpox
outbreak. This provides details on all aspects of immunization clinic
operations and staffing and includes an example of a model smallpox
vaccination clinic.
http://www.bt.cdc.gov/agent/smallpox/response-plan/index.asp
November 2, 2002. Tri-State Hospital Supply Corp. of Howell, MI, recalled its Centurion® Mouth Care Kits that contain oral swabs because the sponge may become dislodged from the handle and potentially present a choking hazard. These products were distributed nationwide to hospitals after April 1, 2002 and consumers may have them home from a hospital or hospice and have them in their possession. The oral swabs were contained in Mouth Care Kits; some items were sold under the SHIELD Healthcare Center label as Enteral Feeding Kits:
http://www.fda.gov/oc/po/firmrecalls/tristate11_02.html
COURSES FOR THE INFECTION CONTROL PROFESSIONAL
"Infection Control in Long-Term Care Facilities" will be held March 17-19, 2003 at The Friday Center in Chapel Hill.
"Infection Control Part I: Clinical Surveillance of Healthcare-Associated Infections will be held May 5-9, 2003 at the Holiday Inn in Chapel Hill.
Contributors to Report of the Month: Karen K. Hoffmann, RN, MS, CIC; William A. Rutala, PhD, MPH; David J. Weber, MD, MPH; Eva P. Clontz, MEd.
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.
Copyright 2002 Statewide Program for Infection Control and Epidemiology
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