CMS SOM App. H, Tag V216

5.3.4.2 Ozone generators: system requirements/monitoring

6.3.4 Bacterial control devices

Ozone can be used for bacterial control only in systems constructed from ozone-resistant

materials (see AAMI 5.3.3 for suitable piping materials).

5.3.4.2 Ozone generators

Refer to RD62:2001, 4.3.15 Ozone disinfection systems: When used to control bacterial

proliferation in water storage and distribution systems, an ozone generator should be

capable of delivering ozone at the concentration and for the exposure time specified by the

manufacturer.

6.3.4 Bacterial control devices

6.3.4.2 Ozone generators

Ozone generators should be monitored for ozone output at a level specified by the

manufacturer. The output of the ozone generator should be measured by the ozone

concentration in the water. A test based on indigo trisulfonate chemistry, or the equivalent,

should be used to measure the ozone concentration …each time disinfection is performed.

An ozone-in-ambient-air test should be conducted on a periodic basis, as recommended by

the manufacturer, to ensure compliance with the OSHA permissible exposure limit of 0.1

ppm. A log sheet should be used to indicate that monitoring has been performed.

Interpretive Guidance § 494.40(a)

ANSI/AAMI RD52:2004

5.3.4.2 Ozone generators

Ozone may be used to control bacterial proliferation in water storage and distribution systems.

Ozone may also degrade endotoxins. Therefore, ozone can be used for bacterial control only in

systems constructed from ozone-resistant materials. Ozone generators convert oxygen in air to

ozone using a corona discharge or ultraviolet irradiation. The ozonated air is then injected into

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the water stream. An ozone concentration of 0.2 mg/L to 0.5 mg/L, combined with a contact time

of 10 minutes, is capable of killing bacteria, bacterial spores, and viruses in water. Destruction

of established biofilm may require longer exposure times and/or higher concentrations of ozone.

Ozone may degrade many plastic materials, including PVC and elastomeric O-rings and seals.

Additional Guidance:

Ozone exposure may have a harmful and destructive effect on some plastic or metal materials.

Therefore, it is not recommended for disinfection of many of the water distribution loop

materials. Refer to Table 2 at V212.

The manufacturer of an ozone disinfection system is typically responsible for validating the

recommended operating conditions to demonstrate that the system provides adequate reduction

in bacterial and endotoxin levels. Refer to the manufacturer’s guidance for required

concentrations, contact time, and disclosure on the effectiveness of the system in killing bacteria

and endotoxins.

The presence of ozone in product water may be harmful to patients. Staff must monitor the

system disinfection to ensure that (1) the generator delivers ozone at the concentration and

exposure time specified by the manufacturer and (2) there is a mechanism in place to detect

ozone in the area of the ozone generator when ozone disinfection systems are used. Facility

policy must define the frequency for “periodic basis” for testing the levels of ozone in ambient

air. This policy should reflect the manufacturer’s guidance and OSHA requirements for exposure

limits.