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NEWS
FEATURES
LEGISLATIVE/REGULATORY NEWS
QUESTION OF THE MONTH
COURSES FOR THE INFECTION CONTROL PROFESSIONAL
NEWS FEATURES
FDA Issues New Regulations on Reuse of Medical Devices
On August 2, 2000, the Federal Drug Administration (FDA) issued new rules for reuse of single-use devices (SUDs). Reuse has gained popularity over the last 20 years as a cost-saving measure. The FDA began investigating the practice of reuse a year ago in response to concerns about certain complicated types of SUDs like those used in cardiac catheter procedures being reused. The new requirements apply equally to both third party reprocessing companies and hospitals. These rules require that anyone that cleans and reuses SUDs must register with the FDA for pre-approval, device labeling and adverse event reporting. A phased-in schedule for inspecting reprocessing operations (including hospitals) for active enforcement of all premarket submission requirements of SUDs deemed high risk (class III) devices (e.g., implanted infusion pumps, endotrachael tube charger) will begin within 6 months of the issuance of the FDA's final guidance document on reuse, within 12 months for moderate risk (class II) SUDS (e.g., angiography catheters), and within 18 months for low risk (class I) SUDs (e.g., gas mask, blood pressure cuffs). The rules currently exclude "opened-but-unused" SUDs. The FDA intends to allow a one-year phase-in process for hospitals to comply with non-premarket requirements (e.g., registration, listing, medical device reporting, tracking, corrections and removals, quality system, and labeling) that third party reprocessors already must do.
Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals, issued August 2, 2000 is available by phone at 800-899-0381 or online at www.fda.gov/cdrh/comp/guidance/1168.pdf
AIA Guideline Revisions 2000
The American Institute of Architects (AIA) met in July and revised the draft guidelines document that was published in February, 2000. This final draft will be voted on in November by the AIA membership and if approved will take effect in April of 2001. Judene Bartley reported for the ICAN Prevent News and Commentary that the new proposed guidelines will (1) require a more thorough "infection control risk assessment" (ICRA) with documentation during planning for hospital construction and renovation; (2) require negative air pressure in emergency department triage areas and waiting rooms and in radiology waiting areas to limit airborne diseases; (3) continue to ban "switchable" rooms - rooms that can be changed from negative to positive pressure because of high risk of human errors in controls and elevated costs; (4) permit a wider range of tap-water temperatures (105oF-120oF) in hospitals but will leave nursing home tap-water temperatures the same; (5) require an extra sink in all single-occupancy hospital rooms in addition to the one in the toilet room; this sink must be located outside cubicle curtains to facilitate handwashing access; (6) permit the use of sealed (unopenable) windows to control airborne contaminants such as Aspergillus; (7) require that operating rooms in outpatient surgery centers maintain positive air pressure over the weekends; (8) call for providing space in emergency department for decontamination of people exposed to biological, chemical, or radioactive agents. The draft guidelines are available on-line at the AIA website (choose "Resources") www.e-architect.com/
REGULATORY/LEGISLATIVE
North Carolina TB
Rules
The North Carolina TB Medical Advisory Committee met in July and recommended the following updates be made to the TB Control Manual per the revised guideline issued by the American Thoracic Society (ATS) and the Centers for Disease Control and Prevention (CDC), "Targeted Tuberculin Testing and Treatment of Latent Tuberculosis Infection" published in the April 2000 issue of Am J Resp Crit Care Med, Vol 161, pp S221-S247 (see May/June 2000 Report of the Month). The sections to be changed include Mantoux Tuberculin Skin Testing (TST) defining conversion for infants and immunocompromised individuals and guidelines for interpreting and ordering x-rays in suspected TB patients. The paragraph on candidates for treatment of latent TB infection (LTBI) was modified to reflect the addition/changes made for TST interpretation. The section on treatment regimen for LTBI was completely rewritten. Finally the section on monitoring of LTBI was updated.
The changes will be finalized in the next month or two. The updates will be posted on the internet at tbnc.mc.duke.edu/manual.htm in the TB manual.
QUESTION OF THE MONTH
Hepatitis B Vaccine
Q: Our hospital pharmacist has asked to replace the one adult dose of hepatitis B (HBV) vaccine given to our healthcare workers by the occupational health department with two doses of pediatric HBV vaccine. The rationale is that it is the same dose if two pediatric vaccine doses are given together and it is cheaper. Is this acceptable?
A: SPICE is not aware of data that support the use of two pediatric HBV vaccine doses (10 meq) for one adult immunization (20 meq). The Federal Drug Administration has not approved using the pediatric vaccine for adults. The CDC does not recommend this practice either.
COURSES FOR THE INFECTION CONTROL PROFESSIONAL
"Infection Control Part II: The ICP as an Environmentalist" will be held September 25-29, 2000 at the Holiday Inn in Chapel Hill.
"Infection Control in Home Health and Hospice" will be held October 30, 2000 at The Friday Center 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 2000 North Carolina Statewide Program for Infection Control and Epidemiology
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