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

 

 

 

 

Industry Term