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H2O2’s overblown safety claims are dangerous

All chemicals capable of achieving terminal sterility are inherently dangerous requiring exposure monitoring, training and engineered redundancies designed to offer the highest level of operator protection. Claiming your sterilant is “safe” and “non-toxic” does a serious disservice to users who may, then, not treat the sterilant with the respect it deserves. Our aim in this post is not to compare H2O2 and EO (both are potentially dangerous and must be used with care). Instead, we hope to demonstrate widespread instances of operator injury in hopes of encouraging fair comparison and careful use.

Lawrence F. Muscarella, Ph.D.

LFM Healthcare Solutions, LLC


The FDA’s adverse events (or, “MAUDE”) database was reviewed to identify medical device reports submitted during the past five years that involve use of a low-temperature system or process labeled to sterilize various types of heat- and moisture-sensitive reusable medical instruments used in the healthcare setting.

This review focused on reports satisfying the following two criteria: the process uses hydrogen peroxide (H2O2) as a vapor or gas plasma to achieve sterilization; and the FDA report described actual or potential harm to healthcare workers.


This review aimed to provide perspective and context when comparing the safety of H2O2-based systems to alternative low-temperature systems labeled to achieve instrument sterilization. The reviewed adverse event reports were obtained by searching the MAUDE database using the product code “MLR,” which FDA uses to classify processes or systems that use a chemical to achieve sterilization.

This review was limited to evaluating employee safety, not patient safety per se. Low-temperature sterilization systems using a chemical agent other than H2O2 to achieve sterilization were excluded from this analysis. This review’s definition of “harm” is broad and is not intended to necessarily imply a healthcare worker was permanently injured. Harm in this context also includes transient self-healing skin reactions, for example. 


Several reports were identified describing actual or potential harm to healthcare employees associated with use of H2O2-based low-temperature sterilization systems. These cases include reports describing skin burns, respiratory complaints, headaches and eye irritation, among other types of harms.

Not every identified case reported that medical treatment was necessarily required, sought and/or administered, although this review could not independently verify this claim or any other findings, assertions or claims provided in the reports.

The following list provides a random sample of several of the FDA reports that this review identified. The text of each of these listed reports is abbreviated. For completeness and context, the report should be read in its entirety. These reports were not limited to any one specific manufacturer or H2O2-based sterilization system.

1. Skin irritation, burns

2. Respiratory complaints

3. Neurological symptoms

4. Eye irritation

5. Nausea, dizziness

6. Flames and/or fire department dispatched