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.