(175 days)
Sporicidin® Sterilizing and Disinfecting Solution (SSDS) is intended for sterilization or high level disinfection of medical and surgical instruments that require submersion. SSDS is intended for reprocessing only heat-sensitive medical devices.
Sporicidin® Sterilizing and Disinfecting Solution (SSDS) should be used under the following contact conditions:
| Time | Temperature | |
|---|---|---|
| Sterilization | 12 hours | 25 degrees C |
| High Level | ||
| Disinfection | 20 minutes | 25 degrees C |
SSDS can be reused for a maximum of 7 days or until Sporicidin Test Strips indicate that either the glutaraldehyde or phenol level falls below its Minimum Recommended Concentration (MRC). The glutaraldehyde MRC is 0.6%; the phenol MRC is 1.3%.
Sporicidin Indicator Strips are intended for verifying the MRC of glutaraldehyde and phenol in SSDS during use. Sporicidin Indicator strips should be used before each use of SSDS.
Sporicidin® Sterilizing and Disinfecting Solution (SSDS) is a liquid chemical sterilant and high level disinfectant. The product contains two solutions: a buffer containing 1.7% phenol/phenate, and an activator containing 25% glutaraldehyde. When the two solutions are mixed, or activated, SSDS contains 0.95 % glutaraldehyde and 1.64% phenol/phenate. The solutions are combined at the user level, resulting in the activated germicide.
SSDS is a liquid chemical sterilant and a high level disinfectant when used or reused according to the DIRECTIONS FOR USE included in the package insert. SSDS can be reused for a maximum of 7 days or until Sporicidin Test Strips indicate that either the glutaraldehyde or phenol level falls below its Minimum Recommended Concentration (MRC). The MRC for glutaraldehyde is 0.6%, and 1.3% for phenol/phenate.
Sporicidin® Sterilizing and Disinfecting Solution (SSDS) must be used with Sporicidin Indicator Strips, used to verify that the MRC of active ingredients is present. It is recommended that SSDS be tested with Sporicidin Indicator Strips prior to each use.
The provided documentation describes the efficacy testing and acceptance criteria for Sporicidin® Sterilizing and Disinfecting Solution (SSDS).
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for SSDS are based on its ability to act as a liquid chemical sterilant and high-level disinfectant. The performance is assessed against various microorganisms under specified conditions. The Minimum Recommended Concentration (MRC) levels for glutaraldehyde (0.6%) and phenol (1.3%) are also key acceptance criteria, along with specific contact times and temperatures.
| Acceptance Criteria (Intended Use Conditions) | Target Microorganism Type | Reported Device Performance |
|---|---|---|
| Sterilization: 12 hours immersion at 25°C with MRC levels (0.6% glutaraldehyde, 1.3% phenol) | Spores (Bacillus subtilis, Clostridium sporogenes) | Effective at 12 hours at 25°C (freshly activated and reused solution) |
| High-Level Disinfection: 20 minutes immersion at 25°C with MRC levels (0.6% glutaraldehyde, 1.3% phenol) | High-Level Disinfection (Mycobacterium bovis, Mycobacterium terrae) | Effective within 20 minutes at 25°C (freshly activated and reused solutions) |
| Vegetative Organisms (Pseudomonas aeruginosa, Salmonella cholerasuis, Staphylococcus aureus) | Effective within 10 minutes at 20°C (freshly activated and reused solutions) | |
| Fungi (Trichophyton mentagrophytes) | Effective within 10 minutes at 20°C (freshly activated and reused solutions) | |
| Non-Lipid Small Virus (Poliovirus Type II, Coxsackie, Rotavirus) | Effective within 3 minutes at 23°C (Poliovirus Type II) | |
| Effective within 2 minutes at 23°C (Coxsackie) | ||
| Effective within 2 minutes at 20°C (Rotavirus) (reused solutions) | ||
| Lipid Medium Virus (Herpes simplex Type I, Herpes simplex Type II, HIV-1, Influenza Type A2) | Effective within 3 minutes at 25°C (Herpes simplex Type I & II) | |
| Effective within 1 minute at 23°C (HIV-1 (HTLV-IIIRF) strain) | ||
| Effective within 10 minutes at 20-25°C (Influenza Type A2) (reused solutions) | ||
| Lipid Large Virus (Vaccinia, Cytomegalovirus) | Effective within 10 minutes at 20-25°C (Vaccinia) | |
| Effective within 2 minutes at 20°C (Cytomegalovirus) (reused solutions) | ||
| Simulated In-Use Testing: Effective in reducing Mycobacterium terrae by 10^6 on endoscopes within 15 minutes at 25°C with active ingredient levels near or below MRC. | Mycobacterium terrae (on endoscopes) | Solutions with active ingredient levels near or below MRC were effective in reducing Mycobacterium terrae by 10^6 on endoscopes in 15 minutes at 25°C. |
| Residue Testing: No detectable glutaraldehyde, phenol levels |
§ 880.6885 Liquid chemical sterilants/high level disinfectants.
(a)
Identification. A liquid chemical sterilant/high level disinfectant is a germicide that is intended for use as the terminal step in processing critical and semicritical medical devices prior to patient use. Critical devices make contact with normally sterile tissue or body spaces during use. Semicritical devices make contact during use with mucous membranes or nonintact skin.(b)
Classification. Class II (special controls). Guidance on the Content and Format of Premarket Notification (510(k)) Submissions for Liquid Chemical Sterilants/High Level Disinfectants, and user information and training.