Medical Devices

Alternatives to STERIS System 1

FDA-cleared sterilization and disinfection products

The purpose of this document is to help health care facilities and health care professionals identify legally-marketed alternatives to replace the STERIS System 1 (SS1).

Recommendations for identifying replacement reprocessing devices

As healthcare facilities and professionals review the available options, FDA recommends the following steps:

Identify which devices your facility is currently reprocessing using an SS1
For each device being reprocessed, identify the type of reprocessing needed by
- Reviewing the manufacturer's instructions for reprocessing for each device
- Reviewing relevant guidance from the CDC and various professional organizations on device reprocessing (see links at the end of this document)
- Considering the Spaulding classification for reprocessing (after thorough cleaning)
  - Critical device - used in a normally sterile body site - needs sterilization
  - Semicritical device - contacts intact mucosal surfaces - needs high level disinfection
  - Noncritical - contacts only intact skin - needs intermediate or low level disinfection
Select a reprocessing device that will provide the type of reprocessing you need for your devices
Contact the manufacturer of the reprocessing device to confirm that it will be compatible with your devices and to check its availability
If the recommendations from the manufacturers of the medical devices to be reprocessed and the reprocessing device seem to disagree, follow the instructions from the manufacturer of the device to be reprocessed.

Notes about FDA databases

The listings below are derived from public databases of medical devices cleared by FDA. The information in this database is taken from the original files submitted. In each category, the most recently cleared devices are listed first. Users need to be aware of the following:

Some companies have been acquired by other companies or have gone out of business
Some products may now be marketed by other companies or under new names
Some companies have changed their locations and contact information

FDA will update these listings when new products are cleared or if we learn that a device is no longer on the market.

1. FDA-cleared Endoscope Washer Disinfectors / Automated Endoscope Reprocessors

This list identifies FDA-cleared Endoscope Washer Disinfectors/Automated Endoscope Reprocessors (AER). When AERs are listed with specific liquid chemical sterilants or high level disinfectants (LCS/HLD), only those products can be used with the devices. When an AER is listed with "Most FDA Cleared", a number of cleared LCS/HLD can be used with that device. Check with the manufacturer for the specific LCS/HLD that have been validated for use with a particular AER.

510(k) Number	Manufacturer	Device Name	LCS / HLD Used
K040883 K061899 K082392	Advanced Sterilization Products (ASP)	Evotech Endoscope Reprocessor/Evotech Endoscope Cleaner and Reprocessor	Cidex OPA Concentrate
K063876	Medivators	MDS for Endoscope Reprocessing	Most FDA Cleared
K061430	Custom Ultrasonics	System 83 Plus Miniflex Washer-Disinfector	Most FDA Cleared
K060458	Langford IC Systems	Manzi Mach 1 Instrument Cleaner-Processor System	Manzi Sterilant MS10
K040049	Steris Corp.	Reliance Endoscope Reprocessing System	Reliance DG Dry Germicide
K983017	Custom Ultrasonics	System 83 Plus Endoscope Washer-Disinfector	Most FDA Cleared
K914145	Medivators	DSD-91 Disinfector for Flexible Endoscopes	Most FDA Cleared
K082988	Medivators	Advantage Plus Endoscope Reprocessing System	Rapicide PA High Level Disinfectant

2. FDA-Cleared Liquid Chemical Sterilants/High Level Disinfectants

This list identifies FDA-cleared liquid chemical sterilants and high level disinfectants (LCS/HLD) with general claims for reprocessing reusable medical devices.

While all LCS/HLD are required to demonstrate their ability to kill spores (liquid chemical sterilant), not all of these are practical for device sterilization. Some of these products require a long contact time for sterilization. In many cases, this is impractical and may result in damage to the reprocessed equipment. Therefore, these products are used only at shorter contact times to kill mycobacteria and a small number of spores (high level disinfection). These LCS/HLD products are labeled "No indication for device sterilization".

Please note that some LCS/HLD are labeled "Indication for sterilization". The contact times needed for sterilization with these products are still relatively long (several hours). Most of these products are not practical for sterilization of delicate, heat-sensitive devices such as endoscopes because of the long contact time.

Manufacturer	Active Ingredient(s)	Sterilant Contact Conditions	High Level Disinfectant Contact Conditions
K051305 TD-5 High-level Disinfectant
CS Medical, L.L.C.	2.65% glutaraldehyde	No indication for device sterilization. Passes the AOAC Sporicidal Activity Test in 10 hrs at 22 °C.	5 min at 37.8ºC Single use to be used exclusively with the TD-100 Transesophageal Probe Disinfector. Contact conditions established by simulated use testing with endoscopes.
K041984 Acecide™ High Level Disinfectant and Sterilant
Minntech Corp	8.3% hydrogen peroxide 7.0% peracetic acid	Indication for device sterilization. 5 hrs at 25°C 5 days Maximum Reuse Contact conditions based on AOAC Sporicidal Activity Test only.	5 min at 25°C 5 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes
K041360 Aldahol III High Level Disinfectant
Healthpoint LTD	3.4% glutaraldehyde 26% isopropanol	Indication for device sterilization. 10 hrs at 20° C Contact conditions based on AOAC Sporicidal Activity Test only.	10 min at 20ºC 14 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes.
K012889 Banicide Advanced for Sterilization and High Level Disinfection
Pascal Company, Inc.	3.5% glutaraldehyde	Indication for device sterilization. 10 hrs at 25°C 30 days Maximum Reuse Contact conditions based on AOAC Sporicidal Activity Test only.	45 min at 25°C 30 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes.
K032959 Cidex® OPA Concentrate
Advanced Sterilization Products	5.75% ortho-phthaldehyde (OPA)	No indication for device sterilization. In-Use solution (0.05% OPA) passes the AOAC Sporicidal Activity Test in 32 hrs at 50°C.	5 min at 50ºC Single use – diluted by system For use in the EvoTech Integrated Endoscope Disinfection System only. Contact conditions established by simulated use testing with endoscopes.
K030004 Cidex OPA Solution
Advanced Sterilization Products	0.55% ortho-phthaldehyde	No indication for device sterilization. Passes the AOAC Sporicidal Activity Test in 32 hrs at 20°C and 25°C.	Manual Processing 12 min at 20°C 14 days Maximum Reuse Automated Endoscope Reprocessor (AER) 5 min at 25°C 14 days Maximum Reuse (For processing in an AER only with FDA-cleared capability to maintain solution temperature at 25°C.) Contact conditions established by simulated use testing with endoscopes.
K013280 Sterilox Liquid High Level Disinfectant System
Sterilox, Technologies, Inc.	Hypochlorite and Hypochlorous acid 650-675 ppm Active free chlorine	No indication for device sterilization. Passes the Modified AOAC Sporicidal Activity Test in 24 hrs at 25°C.	10 min at 25°C Single use - generated on site Contact conditions established by simulated use testing with endoscopes.
K993042 Rapicide High Level Disinfectant and Sterilant
MediVators, Inc.	2.5% glutaraldehyde	Indication for device sterilization. 7 hrs 40 min at 35°C 28 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes and additional supporting information.	Automated Endoscope Reprocessor 5.0 min at 35°C 28 days Maximum Reuse (For processing in an AER only with FDA-cleared capability to maintain the solution temperature at 35°C.) Contact conditions established by simulated use testing with endoscopes.
K991487 °Cidex®OPA Solution High Level Disinfectant
Advanced Sterilization Products	0.55% ortho-phthaldehyde	No indication for device sterilization. Passes the AOAC Sporicidal Activity Test in 32 hrs at 20°C.	12 min at 20°C 14 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes.
K974188 °Cetylcide-G Concentrate and Diluent Concentrate
Cetylite Industries, Inc.	3.2% glutaraldehyde	Indication for device sterilization. 10 hrs at 20°C 28 days Maximum Reuse Contact conditions based on AOAC Sporicidal Activity Test only.	40 min at 20°C 28 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes.
K974062 MedSci 3% Glutaraldehyde
MedSci, Inc.	3% glutaraldehyde	Indication for device sterilization. 10 hrs at 25°C 28 days Maximum Reuse Contact conditions based on AOAC Sporicidal Activity Test only.	25 min at 25°C 28 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes.
K972708 EndoSpor Plus Sterilizing and Disinfecting Solution Note: Due to the lack of test strips for monitoring the concentrations of the active ingredients, the reuse period is limited to 14 days.
Cottrell Limited	7.35% hydrogen peroxide 0.23% peracetic acid	Indication for device sterilization. 180 min at 20°C 14 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes.	15 min at 20°C 14 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes.
K960513 Peract^TM 20 Liquid Sterilant/Disinfectant
Minntech Corporation	1.0% hydrogen peroxide 0.08% peracetic acid	Indication for device sterilization. 8 hrs at 20°C 14 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes.	25 min at 20°C 14 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes.
K931592 Metricide Plus 30 Long-Life Activated Dialdehyde Solution
Metrex Research, Inc.	3.4% glutaraldehyde	Indication for device sterilization. 10 hrs at 25°C 28 days Maximum Reuse Contact conditions based on AOAC Sporicidal Activity Test only. FDA accepted Metricide Plus as identical to Cidex Plus.	90 min at 25°C 28 days Maximum Reuse FDA accepted Metricide Plus as identical to Cidex Plus.
K931052 Metricide 28 Long-Life Activated Dialdehyde Solution
Metrex Research, Inc.	2.5% glutaraldehyde	Indication for device sterilization. 10 hrs at 25°C 28 days Maximum Reuse Contact conditions based on AOAC Sporicidal Activity Test only. FDA accepted Metricide 28 as identical to Cidex Formula 7.	90 min at 25°C 28 days Maximum Reuse FDA accepted Metricide 28 as identical to Cidex Formula 7.
K924434 Cidex™ Activated Dialdehyde Solution
Johnson & Johnson Medical Products	2.4% glutaraldehyde	Indication for device sterilization. 10 hrs at 25°C 14 days Maximum Reuse Contact conditions based on AOAC Sporicidal Activity Test only.	45 min at 25°C 14 days Maximum Reuse Contact conditions based on literature references.
K923744 Cidex Plus^TM 28 Day Solution
Johnson & Johnson Medical Products	3.4% glutaraldehyde	Indication for device sterilization. 10 hrs at 20-25°C 28 days Maximum Reuse Contact conditions based on AOAC Sporicidal Activity Test only.	20 min at 25°C 28 days Maximum Reuse Contact conditions based on literature references.
K914749 Wavicide - 01
Wave Energy Systems	2.5% glutaraldehyde	Indication for device sterilization. 10 hrs at 22°C 30 days Maximum Reuse Contact conditions based on AOAC Sporicidal Activity Test only.	45 min at 22°C 30 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes.
K080420 Resert XL HLD High Level Disnfectant
Steris Corporation	2.0% Hydrogen peroxide	No indication for device sterilization. In-Use solution passes the AOAC Sporicidal Activity Test in 6 hrs at 20 °C	8 min at 20ºC 21 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes.
K070627 Opaciden Solution
Ciden Technologies, LLC	*0.60% ortho-phthalaldehyde (OPA)*	No indication for device sterilization. In-Use solution passes the AOAC Sporicidal Activity Test in 32 hrs at 21 ° C and 32 hrs at 25-27°C.	For Manual Processing: 12 min at 20ºC 14 days Maximum Reuse For processing in a legally marketed Automated Endoscope Reprocessor capable of maintaining solution temperature at 25ºC: 5 min at 25ºC 14 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes.
K063159 Sterilox High Level Disinfectant System
Sterilox, Technologies, Inc.	Hypochlorous acid/hypochlorite 400-450 ppm Active free chlorine	No indication for device sterilization. Passes the Modified AOAC Sporicidal Activity Test in 32 hrs at 30 ° C.	10 min at 30ºC Single use - generated on site Contact conditions established by simulated use testing with endoscopes.
K060618 Cidex Activated Dialdehyde Solution
Advanced Sterilization Products	2.4% glutaraldehyde	10 hrs at 25 °C 14 days Maximum Reuse Contact conditions based on AOAC Sporicidal Activity Test and by simulated use testing with endoscopes.	45 min at 25 °C 14 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes.

3. FDA-Cleared Low Temperature Sterilizers Using Hydrogen Peroxide or Ozone

This list identifies FDA-cleared low-temperature sterilizers which use hydrogen peroxide vapor/plasma or ozone as the sterilant. These products can terminally sterilize wrapped devices and also devices with lumens.

The low temperature sterilizer "lumen claims" identify the smallest diameter and the longest channel length dimensions of the endoscopes that they can reprocess. The lumen claims vary by sterilizer model and manufacturer. When evaluating these sterilizers, check their specific claims against the lumen dimensions of any endoscope which you wish to reprocess.

510(k) Number	Manufacturer	Device Name	Sterilant
K020875 K090636	TSO3, Inc.	TSO3 ozone sterilizer, model 125L	Ozone
K083097	Steris	Amsco V-pro 1	Hydrogen Peroxide Vapor
K071385	Advanced Sterilization Products (ASP)	Sterrad 100NX sterilizer	Hydrogen Peroxide Vapor
K062297	Steris	VHP 136	Hydrogen Peroxide Vapor
K042116	Advanced Sterilization Products (ASP)	Sterrad NX sterilizer	Hydrogen Peroxide Vapor
K030429	ASP	Sterrad 200 sterilizer	Hydrogen Peroxide Vapor

4. FDA-Cleared Ethylene Oxide Sterilizers

This link will take you to a list of FDA-cleared ethylene oxide sterilizers. Most of these devices were cleared some time ago. Their instructions for use will have limited if any information on the endoscope lumen sizes appropriate for use in these sterilizers and they will usually also lack aeration time information specific to endoscopes.

FDA recommends that you review the reprocessing instructions from the endoscope/medical device manufacturer for information on specific ethylene oxide sterilizer cycle time, humidity and concentration (% of ethylene oxide), and aeration time. If this information is not provided in the endoscope/medical device labeling, you should contact the manufacturer of the device to determine the exact reprocessing parameters that have been validated before you reprocess that device in an ethylene oxide sterilizer.

List of FDA-Cleared Ethylene Oxide Sterilizers

5. List of FDA-Cleared Steam Sterilizers

This link will take you to a list of FDA-cleared steam sterilizers.

Most endoscopes and other reprocessed devices are sensitive to heat and cannot be processed using steam sterilizers. Liquid chemical sterilization is not a terminal sterilization process and should be used only for heat-sensitive devices which cannot be processed by any other method such as low temperature terminal sterilization by hydrogen peroxide, ozone or ethylene oxide. Any devices that can tolerate steam sterilization, such as certain simple, rigid endoscopes, should be reprocessed using steam sterilization and not in the SS1.

The microbial kill kinetics of liquid chemical sterilization are complex and non-linear. A "sterility assurance level" cannot be calculated for liquid chemical sterilization and this process is to be used only for heat-sensitive devices which cannot be sterilized by any other means.

To find a list of FDA-cleared steam sterilizers enter FLE in the Product Code Box in the link below:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm

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