High-Level Disinfectants are powerful antimicrobial formulations used in medical facilities to reprocess and disinfect contaminated heat-sensitive critical and semi-critical medical devices, such as endoscopes. In March, 2015, FDA updated its database of approved products. Microchem evaluated the data and presents its findings below.

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 NameCompanyActive IngredientActive Ingredient LevelSterilant Contact ConditionsHigh-Level Disinfectant Contact ConditionsDays of Re-Use
Acecide-C High Level Disnfectant and SterilantBest SanitizersPeracetic Acid0.31-0.34%2 hrs, 20ºC7 min, 20ºC5
OPA 30 SolutionCiden Tech.OPA0.60%32 hrs, 20ºC12 min, 20ºC30
Extended Use Aldahol High Level DisinfectantOlympusGlutaraldehyde + Isopropanol3.4% Glut.
20.1% Iso.
6 hrs, 25ºC5 min, 25ºC14
Rapicide OPA-28 High Level Disinfectant MinntechOPA0.58%32 hrs, 20ºC10 min, 20ºC28
Resert XL HLD High Level DisinfectantSterisHydrogen Peroxide2.00%6 hrs, 20ºC8 min, 20ºC21
Cidex OPA Concentrate ASPOPA5.75%*32 hrs, 50ºC5 min, 50ºCN/A

Which Companies have Registered the Most High-Level Disinfectants with FDA in 2015?
Company NameNumber of Approved
High-Level Disinfectants
Advanced Sterilization Products4
Cottrell Limited
Johnson & Johnson Medical Products3
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
TOTAL35

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 TemperatureManufacturerProductReuse Time
20°CCIDEN TECHNOLOGIES, LLCOPA 30 Solution30 days
25°CPASCAL COMPANY, INC.Banicide Advanced30 days
OtherWAVE ENERGY SYSTEMSWAVICIDE – 0130 days @ 22°C
    
High-Level Disinfectants Spotlight: Shortest Contact Time
Active Ingredient TypeManufacturerProductContact Time
GlutaraldehydeCS MEDICAL, LLCTD-5 HLD5 minutes
MEDIVATORS, INCRAPICIDE HLD AND STERILANT5 minutes
Glutaraldehyde + IsopropanolHEALTHPOINT, LTD.EXTENDED USE ALDAHOL HLD5 minutes
Hydrogen Peroxide + Peracetic AcidCOTTRELL LIMITEDEndosporPlus Sterilizing & Disinfecting Solution15 minutes
Peracetic AcidBEST SANITIZERS, INC.ACECIDE HLD & STERILANT5 minutes
Hydrogen PeroxideSTERIS CORPORATIONResert Xl Hld High Level Disinfectant8 minutes
    
High-Level Disinfectants Spotlight: Lowest Percent Active
Contact TimeManufacturerProductPercent Active
< 10 MinutesBEST SANITIZERS, INC.ACECIDE-C HLD & STERILANT0.00325
7-10 MinutesSTERILOX TECHNOLOGIES, INC.STERILOX HLD DISINFECTANT SYSTEM0.000425
12-25 MinutesADVANCED STERILIZATION PRODUCTSCIDEX OPA SOLUTION0.0055
30-45 MinutesRECKITT & COLMAN INC.SPOROX STERILIZING AND DISINFECTING SOLUTION0.075
    
Sterilant Spotlight: Lowest Percent Active Ingredient
CategoryManufacturerProductPercent Active
OverallSterilox Technologies, Inc.Sterilox HLD Disinfectant SystemAveraged 425 ppm Free Chlorine,(0.0425%)
    
Sterilant Spotlight: Shortest Contact Time
Active Ingredient TypeManufacturerProductPercent Active
Overall (All Actives)Best Sanitizers, Inc.Acecide-C HLD & Sterilant120 minutes
Free ChlorineSterilox Technologies, Inc.Sterilox Liquid HLD System1440 minutes
GlutaraldehydeMedivators, Inc.Rapicide HLD and Sterliant460 minutes
Glutaraldehyde + IsopropanolHealthpoint, LTDExtended Use Aldahol HLD360 minutes
Hydrogen Peroxide + Peracetic AcidCottrell LimitedEndospor Plus Sterilizing and Disinfecting Solution180 minutes
Peracetic AcidBest Sanitizers, Inc.Acecide-C HLD & Sterilant120 minutes
    
Sterilant Spotlight: Maximum Reuse Time
CategoryManufacturerProductReuse Time
OverallPascal Company, Inc.Banicide Advanced30 days max reuse
Wave Energy SystemsWavicide – 0130 days max reuse
    
High-Level Disinfectant and Sterilant Product Spotlight
ManufacturerProduct
BEST SANITIZERS, INC.ACECIDE-C HLD & STERILANT

Below is FDA's 2015 data in tabular form, used for all charts above.

Sterilization Contact ConditionsHigh Level Disinfection Contact Conditions
ManufacturerProduct NameActive(s)Concentrationcontact time
(min)
contact temp
(°C)
max reuse
(days)
contact time
(min)
contact temp
(°C)
max reuse
(days)
BEST SANITIZERS, INC.ACECIDE-C HLD & STERILANTPERACETIC ACID3100-3400 ppm1202057205
HEALTHPOINT, LTD.EXTENDED USE ALDAHOL HLDGLUTARALDEHYDE
ISOPROPANOL
3.4%
20.1%
360251452514
STERIS CORPORATIONRESERT XL HLD HIGH LEVEL DISINFECTANTHYDROGEN PEROXIDE2.00%36020N/A82021
MICROCHEM LABORATORIES, INC.ALDAHOL V HLDGLUTARALDEHYDE ISOPROPANOL3.4%
20.1%
4802014102014
MINNTECH CORPORATIONRAPICIDE OPA-28 HLDOPA0.575%192020 + 25N/A102028
52528
CIDEN TECHNOLOGIES, LLCOPA 30 SOLUTIONOPA0.6%192020 + 25N/A122030
52514
BEST SANITIZERS, INC.ACECIDE HLD & STERILANTPERACETIC ACID3300-3800 ppm3002555255
CS MEDICAL, LLCTD-5 HLDGLUTARALDEHYDE2.65%60022N/A537.80
HEALTHPOINT, LTD.ALDAHOL III HLDGLUTARALDEHYDE
ISOPROPANOL
3.4%
26%
60020N/A102014
PASCAL COMPANY, INC.BANICIDE ADVANCED FOR STERILIZATION AND HLDGLUTARALDEHYDE3.50%6002530452530
ADVANCED STERILIZATION PRODUCTSCIDEX OPA CONCENTRATEOPA5.75%
(0.05% IN USE)
192050N/A5500
ADVANCED STERILIZATION PRODUCTSCIDEX OPA SOLUTIONOPA0.55%192020 + 25N/A122014
52514
STERILOX TECHNOLOGIES, INC.STERILOX LIQUID HLD SYSTEMFREE CHLORINE650-67 5ppm144025N/A10250
SPORICIDIN INTERNATIONALSPORICIDIN STERILIZING AND DISINFECTING SOLUTIONGLUTARALDEHYDE
PHENOL/PHENATE
1.12%
1.93%
7202514202514
MEDIVATORS, INCRAPICIDE HLD AND STERILANTGLUTARALDEHYDE2.50%460352853528
ADVANCED STERILIZATION PRODUCTS°CIDEX OPA SOLUTION HLDOPA0.55%192020 + 25N/A122014
CETYLITE INDUSTRIES, INC.°CETYLCIDE-G CONCENTRATE AND DILUENT CONCENTRATEGLUTARALDEHYDE3.20%6002028402028
MEDSCI, INC.MEDSCI 3% GLUTARALDEHYDEGLUTARALDEHYDE3.00%6002528252528
COTTRELL LIMITEDENDOSPOR PLUS STERILIZING AND DISINFECTING SOLUTIONHYDROGEN PEROXIDE
PERACETIC ACID
7.35%
0.23%
1802014152014
RECKITT & COLMAN INC.SPOROX STERILIZING AND DISINFECTING SOLUTIONHYDROGEN PEROXIDE7.50%3602021302021
MINNTECH CORPORATIONPERACT 20 LIQUID STERILANT/DISINFECTANTHYDROGEN PEROXIDE
PERACETIC ACID
1.0%
0.08%
48020 + 2514252014
COTTRELL LIMITEDPROCIDE 14 N.S.GLUTARALDEHYDE2.40%6002014452014
COTTRELL LIMITEDOMNICIDE PLUSGLUTARALDEHYDE3.40%6002028452028
METREX RESEARCH, INCMETRICIDE PLUS 30 LONG-LIFE ACTIVATED DIALDEHYDE SOLUTIONGLUTARALDEHYDE3.40%6002528902528
METREX RESEARCH, INCMETRICIDE 28 LONG-LIFE ACTIVATED DIALDEHYDE SOLUTIONGLUTARALDEHYDE2.50%6002528902528
METREX RESEARCH, INCMETRICIDE ACTIVATED DIALDEHYDE SOLUTIONGLUTARALDEHYDE2.60%6002514452514
JOHNSON&JOHNSON MEDICAL PRODUCTSCIDEX ACTIVATED DIALDEHYDE SOLUTIONGLUTARALDEHYDE2.40%6002514452514
JOHNSON&JOHNSON MEDICAL PRODUCTSCIDEX FORMULA 7 LONG-LIFE ACTIVATED DIALDEHYDE SOLUTIONGLUTARALDEHYDE2.50%60020-2528902528
JOHNSON&JOHNSON MEDICAL PRODUCTSCIDEX PLUS 28 DAY SOLUTIONGLUTARALDEHYDE3.40%60020-2528202528
WAVE ENERGY SYSTEMSWAVICIDE – 01GLUTARALDEHYDE2.50%6002230452230
STERIS CORPORATIONRESERT XL HLD HIGH LEVEL DISINFECTANTHYDROGEN PEROXIDE2.00%36020N/A82021
CIDEN TECHNOLOGIES, LLCOPACIDEN SOLUTIONOPA0.60%192021 and 25-27N/A122014
52514
STERILOX TECHNOLOGIES, INC.STERILOX HLD DISINFECTANT SYSTEMFREE CHLORINE400-450 ppm192030N/A10300
ADVANCED STERILIZATION PRODUCTSCIDEX ACTIVATED DIALDEHYDE SOLUTIONGLUTARALDEHYDE2.40%6002514452514

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