The FDA Approves 17 Sterilizing and Disinfecting Products for Reprocessing Medical Devices
The Food and Drug Administration (FDA) released a list of the latest approved disinfectants for reprocessing medical devices as of January 28, 2000. The following company products were approved through the 510(k) process:
Advanced Sterilization Products:
- Cidex OPA Solution High Level Disinfectant, (0.55% ortho-phthaldehyde), K991487
Sporicidin International:
- Sporicidin Sterilizing and Disinfecting Solution (0.95% glut and 1.64% phenol/phenate), K983194
Johnson & Johnson Medical Products, Inc.
- Cidex Activated Dialdehyde Solution (2.4% glut), K924434
- Cidex Formula 7 Long-Life Activated Dialdehyde Solution (2.5% glut), K924334
- Cidex Plus 28 Day Solution (3.4% glut), K923744
Metrex Research, Inc.:
- Metricide Activated Dialdehyde Solution (2.6% glut), K930284
- Metricide Plus 30 Long-Life Activated Dialdehyde Solution (3.4% glut), K931592
- Metricide 28 Day Long-Life Activated Dialdehyde Solution (2.5% glut), K931052
Cottrell Limited:
- Procide 14 N.S. (2.4% glut), K932922
- Omnicide Long-Life Activated Dialdehyde Solution (2.4% glut), K932922
- Omnicide Plus (3.4% glut), K932922
Wave Energy Systems:
- Wavicide --01 (2.5% glut), K914749
STERIS Corporation:
- STERIS 20 Sterilant (0.2% peracetic acid), K875280
Minntech Corporation:
- Peract 20 Liquid Sterilant/Disinfectant (0.08% peroxyacetic acid and 1.0% hydrogen peroxide), K960513
Reckitt & Colman, Inc.:
- Sporox Sterilizing & Disinfection Solution (7.5% hydrogen peroxide), K970230
MedSci, Inc.:
- MedSci 3% Glutaraldehyde (3% glut), K974062
Cetylite Industries, Inc.:
- Cetylcide-G Concentrate and Diluent Concentrate (3.2% glut), K974188
More information can be obtained on the Internet at http://www.fda.gov/cdrh/ode/germlab.html.
A Helping Hand: Innovative Approaches to Expanding Hand Hygiene Programs in Acute Care Settings
July 9th 2025Who knew candy, UV lights, and a college kid in scrubs could double hand hygiene adherence? A Pennsylvania hospital’s creative shake-up of its infection prevention program shows that sometimes it takes more than soap to get hands clean—and keep them that way.
Broadening the Path: Diverse Educational Routes Into Infection Prevention Careers
July 4th 2025Once dominated by nurses, infection prevention now welcomes professionals from public health, lab science, and respiratory therapy—each bringing unique expertise that strengthens patient safety and IPC programs.
How Contaminated Is Your Stretcher? The Hidden Risks on Hospital Wheels
July 3rd 2025Despite routine disinfection, hospital surfaces, such as stretchers, remain reservoirs for harmful microbes, according to several recent studies. From high-touch areas to damaged mattresses and the effectiveness of antimicrobial coatings, researchers continue to uncover persistent risks in environmental hygiene, highlighting the critical need for innovative, continuous disinfection strategies in health care settings.