Where Can the Historical and New Data Sets be Found?
FDA has two posted data sets, 2009 and 2015. The 2009 data set is found here and the 2015 data set is found here.
What Changed Between 2009 and 2015?
Between 2009 and 2015, six new high-level disinfectants were added to FDA’s list. Details for the new additions are presented below.
Product Name | Company | Active Ingredient | Active Ingredient Level | Sterilant Contact Conditions | High-Level Disinfectant Contact Conditions | Days of Re-Use |
Acecide-C High Level Disnfectant and Sterilant | Best Sanitizers | Peracetic Acid | 0.31-0.34% | 2 hrs, 20ºC | 7 min, 20ºC | 5 |
OPA 30 Solution | Ciden Tech. | OPA | 0.60% | 32 hrs, 20ºC | 12 min, 20ºC | 30 |
Extended Use Aldahol High Level Disinfectant | Olympus | Glutaraldehyde + Isopropanol | 3.4% Glut. 20.1% Iso. |
6 hrs, 25ºC | 5 min, 25ºC | 14 |
Rapicide OPA-28 High Level Disinfectant | Minntech | OPA | 0.58% | 32 hrs, 20ºC | 10 min, 20ºC | 28 |
Resert XL HLD High Level Disinfectant | Steris | Hydrogen Peroxide | 2.00% | 6 hrs, 20ºC | 8 min, 20ºC | 21 |
Cidex OPA Concentrate | ASP | OPA | 5.75%* | 32 hrs, 50ºC | 5 min, 50ºC | N/A |
Which Companies have Registered the Most High-Level Disinfectants with FDA in 2015?
Company Name | Number of Approved High-Level Disinfectants |
Advanced Sterilization Products | 4 |
Cottrell Limited | |
Johnson & Johnson Medical Products | 3 |
Metrex Research, Inc. | |
Best Sanitizers, Inc. | 2 |
Ciden Technologies, LLC | |
Healthpoint, Ltd. | |
Minntech Corporation | |
Sterilox, Technologies, Inc. | |
Steris Corporation | |
Cetylite Industries, Inc. | 1 |
CS Medical, LLC | |
MediVators, Inc. | |
MedSci, Inc. | |
Microchem Laboratories, Inc. | |
Pascal Company, Inc. | |
Reckitt & Colman Inc. | |
Sporicidin International | |
Wave Energy Systems | |
TOTAL | 35 |
What Active Ingredients are Most Popular Among Approved High-Level Disinfectants?
Which Companies Use Which Active Ingredients?
What is the Molecular Structure of Popular Active Ingredients?
How Does Active Ingredient Relate to Contact Time for High-Level Disinfection?
How Does Active Ingredient Relate to Contact Time for Sterilization?
How Does Use Temperature Relate to High-Level Disinfection Contact Time (Glutaraldehyde)?
How Does Active Ingredient Concentration Relate to Re-Use Life (Glutaraldehyde)?
Microchem recognizes industry-leading HLDs and sterilants:
High-Level Disinfectants Spotlight: Maximum Reuse Time | |||
Use Temperature | Manufacturer | Product | Reuse Time |
20°C | CIDEN TECHNOLOGIES, LLC | OPA 30 Solution | 30 days |
25°C | PASCAL COMPANY, INC. | Banicide Advanced | 30 days |
Other | WAVE ENERGY SYSTEMS | WAVICIDE – 01 | 30 days @ 22°C |
High-Level Disinfectants Spotlight: Shortest Contact Time | |||
Active Ingredient Type | Manufacturer | Product | Contact Time |
Glutaraldehyde | CS MEDICAL, LLC | TD-5 HLD | 5 minutes |
MEDIVATORS, INC | RAPICIDE HLD AND STERILANT | 5 minutes | |
Glutaraldehyde + Isopropanol | HEALTHPOINT, LTD. | EXTENDED USE ALDAHOL HLD | 5 minutes |
Hydrogen Peroxide + Peracetic Acid | COTTRELL LIMITED | EndosporPlus Sterilizing & Disinfecting Solution | 15 minutes |
Peracetic Acid | BEST SANITIZERS, INC. | ACECIDE HLD & STERILANT | 5 minutes |
Hydrogen Peroxide | STERIS CORPORATION | Resert Xl Hld High Level Disinfectant | 8 minutes |
High-Level Disinfectants Spotlight: Lowest Percent Active | |||
Contact Time | Manufacturer | Product | Percent Active |
< 10 Minutes | BEST SANITIZERS, INC. | ACECIDE-C HLD & STERILANT | 0.00325 |
7-10 Minutes | STERILOX TECHNOLOGIES, INC. | STERILOX HLD DISINFECTANT SYSTEM | 0.000425 |
12-25 Minutes | ADVANCED STERILIZATION PRODUCTS | CIDEX OPA SOLUTION | 0.0055 |
30-45 Minutes | RECKITT & COLMAN INC. | SPOROX STERILIZING AND DISINFECTING SOLUTION | 0.075 |
Sterilant Spotlight: Lowest Percent Active Ingredient | |||
Category | Manufacturer | Product | Percent Active |
Overall | Sterilox Technologies, Inc. | Sterilox HLD Disinfectant System | Averaged 425 ppm Free Chlorine,(0.0425%) |
Sterilant Spotlight: Shortest Contact Time | |||
Active Ingredient Type | Manufacturer | Product | Percent Active |
Overall (All Actives) | Best Sanitizers, Inc. | Acecide-C HLD & Sterilant | 120 minutes |
Free Chlorine | Sterilox Technologies, Inc. | Sterilox Liquid HLD System | 1440 minutes |
Glutaraldehyde | Medivators, Inc. | Rapicide HLD and Sterliant | 460 minutes |
Glutaraldehyde + Isopropanol | Healthpoint, LTD | Extended Use Aldahol HLD | 360 minutes |
Hydrogen Peroxide + Peracetic Acid | Cottrell Limited | Endospor Plus Sterilizing and Disinfecting Solution | 180 minutes |
Peracetic Acid | Best Sanitizers, Inc. | Acecide-C HLD & Sterilant | 120 minutes |
Sterilant Spotlight: Maximum Reuse Time | |||
Category | Manufacturer | Product | Reuse Time |
Overall | Pascal Company, Inc. | Banicide Advanced | 30 days max reuse |
Wave Energy Systems | Wavicide – 01 | 30 days max reuse | |
High-Level Disinfectant and Sterilant Product Spotlight | |||
Manufacturer | Product | ||
BEST SANITIZERS, INC. | ACECIDE-C HLD & STERILANT |
Below is FDA’s 2015 data in tabular form, used for all charts above.
Sterilization Contact Conditions | High Level Disinfection Contact Conditions | ||||||||
Manufacturer | Product Name | Active(s) | Concentration | contact time (min) |
contact temp (°C) |
max reuse (days) |
contact time (min) |
contact temp (°C) |
max reuse (days) |
BEST SANITIZERS, INC. | ACECIDE-C HLD & STERILANT | PERACETIC ACID | 3100-3400 ppm | 120 | 20 | 5 | 7 | 20 | 5 |
HEALTHPOINT, LTD. | EXTENDED USE ALDAHOL HLD | GLUTARALDEHYDE ISOPROPANOL |
3.4% 20.1% |
360 | 25 | 14 | 5 | 25 | 14 |
STERIS CORPORATION | RESERT XL HLD HIGH LEVEL DISINFECTANT | HYDROGEN PEROXIDE | 2.00% | 360 | 20 | N/A | 8 | 20 | 21 |
MICROCHEM LABORATORIES, INC. | ALDAHOL V HLD | GLUTARALDEHYDE ISOPROPANOL | 3.4% 20.1% |
480 | 20 | 14 | 10 | 20 | 14 |
MINNTECH CORPORATION | RAPICIDE OPA-28 HLD | OPA | 0.575% | 1920 | 20 + 25 | N/A | 10 | 20 | 28 |
5 | 25 | 28 | |||||||
CIDEN TECHNOLOGIES, LLC | OPA 30 SOLUTION | OPA | 0.6% | 1920 | 20 + 25 | N/A | 12 | 20 | 30 |
5 | 25 | 14 | |||||||
BEST SANITIZERS, INC. | ACECIDE HLD & STERILANT | PERACETIC ACID | 3300-3800 ppm | 300 | 25 | 5 | 5 | 25 | 5 |
CS MEDICAL, LLC | TD-5 HLD | GLUTARALDEHYDE | 2.65% | 600 | 22 | N/A | 5 | 37.8 | 0 |
HEALTHPOINT, LTD. | ALDAHOL III HLD | GLUTARALDEHYDE ISOPROPANOL |
3.4% 26% |
600 | 20 | N/A | 10 | 20 | 14 |
PASCAL COMPANY, INC. | BANICIDE ADVANCED FOR STERILIZATION AND HLD | GLUTARALDEHYDE | 3.50% | 600 | 25 | 30 | 45 | 25 | 30 |
ADVANCED STERILIZATION PRODUCTS | CIDEX OPA CONCENTRATE | OPA | 5.75% (0.05% IN USE) |
1920 | 50 | N/A | 5 | 50 | 0 |
ADVANCED STERILIZATION PRODUCTS | CIDEX OPA SOLUTION | OPA | 0.55% | 1920 | 20 + 25 | N/A | 12 | 20 | 14 |
5 | 25 | 14 | |||||||
STERILOX TECHNOLOGIES, INC. | STERILOX LIQUID HLD SYSTEM | FREE CHLORINE | 650-67 5ppm | 1440 | 25 | N/A | 10 | 25 | 0 |
SPORICIDIN INTERNATIONAL | SPORICIDIN STERILIZING AND DISINFECTING SOLUTION | GLUTARALDEHYDE PHENOL/PHENATE |
1.12% 1.93% |
720 | 25 | 14 | 20 | 25 | 14 |
MEDIVATORS, INC | RAPICIDE HLD AND STERILANT | GLUTARALDEHYDE | 2.50% | 460 | 35 | 28 | 5 | 35 | 28 |
ADVANCED STERILIZATION PRODUCTS | °CIDEX OPA SOLUTION HLD | OPA | 0.55% | 1920 | 20 + 25 | N/A | 12 | 20 | 14 |
CETYLITE INDUSTRIES, INC. | °CETYLCIDE-G CONCENTRATE AND DILUENT CONCENTRATE | GLUTARALDEHYDE | 3.20% | 600 | 20 | 28 | 40 | 20 | 28 |
MEDSCI, INC. | MEDSCI 3% GLUTARALDEHYDE | GLUTARALDEHYDE | 3.00% | 600 | 25 | 28 | 25 | 25 | 28 |
COTTRELL LIMITED | ENDOSPOR PLUS STERILIZING AND DISINFECTING SOLUTION | HYDROGEN PEROXIDE PERACETIC ACID |
7.35% 0.23% |
180 | 20 | 14 | 15 | 20 | 14 |
RECKITT & COLMAN INC. | SPOROX STERILIZING AND DISINFECTING SOLUTION | HYDROGEN PEROXIDE | 7.50% | 360 | 20 | 21 | 30 | 20 | 21 |
MINNTECH CORPORATION | PERACT 20 LIQUID STERILANT/DISINFECTANT | HYDROGEN PEROXIDE PERACETIC ACID |
1.0% 0.08% |
480 | 20 + 25 | 14 | 25 | 20 | 14 |
COTTRELL LIMITED | PROCIDE 14 N.S. | GLUTARALDEHYDE | 2.40% | 600 | 20 | 14 | 45 | 20 | 14 |
COTTRELL LIMITED | OMNICIDE PLUS | GLUTARALDEHYDE | 3.40% | 600 | 20 | 28 | 45 | 20 | 28 |
METREX RESEARCH, INC | METRICIDE PLUS 30 LONG-LIFE ACTIVATED DIALDEHYDE SOLUTION | GLUTARALDEHYDE | 3.40% | 600 | 25 | 28 | 90 | 25 | 28 |
METREX RESEARCH, INC | METRICIDE 28 LONG-LIFE ACTIVATED DIALDEHYDE SOLUTION | GLUTARALDEHYDE | 2.50% | 600 | 25 | 28 | 90 | 25 | 28 |
METREX RESEARCH, INC | METRICIDE ACTIVATED DIALDEHYDE SOLUTION | GLUTARALDEHYDE | 2.60% | 600 | 25 | 14 | 45 | 25 | 14 |
JOHNSON&JOHNSON MEDICAL PRODUCTS | CIDEX ACTIVATED DIALDEHYDE SOLUTION | GLUTARALDEHYDE | 2.40% | 600 | 25 | 14 | 45 | 25 | 14 |
JOHNSON&JOHNSON MEDICAL PRODUCTS | CIDEX FORMULA 7 LONG-LIFE ACTIVATED DIALDEHYDE SOLUTION | GLUTARALDEHYDE | 2.50% | 600 | 20-25 | 28 | 90 | 25 | 28 |
JOHNSON&JOHNSON MEDICAL PRODUCTS | CIDEX PLUS 28 DAY SOLUTION | GLUTARALDEHYDE | 3.40% | 600 | 20-25 | 28 | 20 | 25 | 28 |
WAVE ENERGY SYSTEMS | WAVICIDE – 01 | GLUTARALDEHYDE | 2.50% | 600 | 22 | 30 | 45 | 22 | 30 |
STERIS CORPORATION | RESERT XL HLD HIGH LEVEL DISINFECTANT | HYDROGEN PEROXIDE | 2.00% | 360 | 20 | N/A | 8 | 20 | 21 |
CIDEN TECHNOLOGIES, LLC | OPACIDEN SOLUTION | OPA | 0.60% | 1920 | 21 and 25-27 | N/A | 12 | 20 | 14 |
5 | 25 | 14 | |||||||
STERILOX TECHNOLOGIES, INC. | STERILOX HLD DISINFECTANT SYSTEM | FREE CHLORINE | 400-450 ppm | 1920 | 30 | N/A | 10 | 30 | 0 |
ADVANCED STERILIZATION PRODUCTS | CIDEX ACTIVATED DIALDEHYDE SOLUTION | GLUTARALDEHYDE | 2.40% | 600 | 25 | 14 | 45 | 25 | 14 |