D.C. Mun. Regs. tit. 25, r. 25-G310

Current through Register Vol. 71, No. 49, December 6, 2024

Rule 25-G310 - MAINTENANCE RECORDS - STERILIZERS AND COMMERCIAL BIOLOGICAL INDICATOR MONITORING SYSTEM, AND RETENTION*

310.1

Operators shall ensure that sterilizers are loaded, operated, decontaminated, and maintained according to manufacturer's instructions, and only equipment manufactured for the sterilization of medical instruments shall be used.

310.2

Sterilization equipment shall be tested using a commercial biological indicator monitoring systems ("monitor") after:

(a) Initial installation;

(b) Major repair;

(c) At least once per month; or

(d) At a minimum in compliance with the manufacturer's recommendation.

310.3

The expiration date of a monitor shall be checked prior to each use.

310.4

Each sterilization load shall be monitored with mechanical indicators for time, temperature, pressure, and at a minimum, Class V Indicators. Each individual sterilization pack shall have an indicator.

310.5

Biological indicator monitoring test results shall be recorded in a log that shall be kept on the premises for three (3) years after the date of the results.

310.6

A daily written log of each sterilization cycle shall be maintained on the premises for three (3) years for inspection by the Department and shall include the following information:

(a) The date of the load;

(b) A list of the contents of the load;

(c) The exposure time and temperature;

(d) The results of the Class V Indicator; and

(e) For cycles where the results of the biological indicator monitoring test are positive, how the items were cleaned, and proof of a negative test before reuse.

D.C. Mun. Regs. tit. 25, r. 25-G310

Final Rulemaking published at 64 DCR 13496 (12/29/2017)