Are the use of test strips necessary when using a glutaraldehyde high level disinfectant?
All types of sterilization and high level disinfection HAS to be monitored. Sterilizers use different forms of biological indicators and monitors. Likewise, high level disinfectants, such as OPA and glutaraldehydes, require the same type of monitoring. If there is residual water or any type of residue on whatever is placed in the solution, it can dilute or break down the solution and, in turn, it will not achieve high level disinfection which puts patients at risk.
Per ANSI/AAMI ST58:2013 Chemical sterilization and high-level disinfection in healthcare facilities:
184.108.40.206 Using solution test strips and chemical monitoring devices
Health care personnel should use the FDA-cleared solution test strip or chemical monitoring device recommended by the LCS/HLD manufacturer or a solution test strip or chemical monitoring device cleared by the FDA as substantially equivalent. The manufacturer’s written IFU should provide information on the reliability, safety, and performance characteristics of the product, including the interpretation of the solution test strip or chemical monitoring device reaction, the MRC or MEC that the solution test strip or chemical monitoring device is designed to detect, and the shelf life and storage requirements. Any necessary efficacy testing of the solution test strip or chemical monitoring device should be performed according to the manufacturer’s written IFU.
NOTE—Solution test strips and chemical monitoring devices for LCS/HLD solutions are medical devices that require FDA premarket clearance. The intended-use statement in the labeling of the solution test strip or chemical monitoring device should specify the LCS/HLD products with which it can be used.
Rationale: Solution test strips or chemical monitoring devices are needed to detect inadequate concentration of the active ingredient of the LCS/HLD. See also the Rationale for 220.127.116.11.
18.104.22.168 Frequency of use
Health care personnel should use the appropriate solution test strip or chemical monitoring device to test the LCS/HLD solution. The solution should be tested before each use (ASGE and SHEA, 2011). If the solution test strip or chemical monitoring device indicates that the concentration of the active ingredient is inadequate, the solution should not be used. The solution test strip or chemical monitoring device manufacturer’s written IFU for testing, storage of the strips and reagents, interpretation of results, and expiration should be followed.
Rationale: If the LCS/HLD has a reuse claim or is a single-use product that is prepared on site, the manufacturer should provide or identify an appropriate solution test strip or chemical monitoring device to be used with the product. The purpose of the solution test strip or chemical monitoring device is to ensure that the concentration of the active ingredient in the LCS/HLD solution is at or above the product’s MRC or MEC and to provide an indication of the solution’s continued effectiveness. The concentration of an active ingredient in the LCS/HLD solution will decrease with dilution by water, the presence of organic or other extraneous materials, evaporation of the solution, and exposure of the solution to light. Checking the concentration of the active ingredient before use can reduce the risk associated with use of an ineffective LCS/HLD solution.