Regulations for Autoclaves

An autoclave is a medical grade device utilizing steam under pressure to sterilize medical instruments. Two types of regulations are applicable for autoclaves. Because they uses steam under pressure boiler, safety regulations come into play, as well as regulations concerning the effectiveness of the autoclave in killing micro-organisms.

Operating the Autoclave

• Autoclaves should operate at a minimum of 250 degrees Fahrenheit at 15 pounds per square inch. This temperature and pressure is maintained for a minimum of one hour. Record-keeping requirements vary but may include manually recording temperature and pressure readings during the sterilization process.
  Tests of the autoclaves' functions are usually required weekly. Tests confirm that temperature gauges are accurate within a tolerance of 2 degrees. Tolerances for pressure gauges are 2 pounds per square inch. All manufacturers' operating instructions should be followed.

Autoclave Safety

• Steam under pressure can explode dangerously under some situations. Regulations require a number of internal safety measures within the autoclave as well as modifications to the facility. Boilers, such as an autoclave, generally fall under state regulations, and rules will vary from state to state.
  Autoclaves are required to have automated switches disabling the machine in the event of low water or high pressure. These switches should be tested as part of monthly or annual inspections.
  An emergency shut-off switch should be remotely located at the access door to the room where the autoclave is located. A “blowdown tank” should be located between the autoclave and the sanitary sewer drains. This allows the hot water and steam vented from the autoclave to cool before being introduced into the sewer pipes.

Autoclave Record Keeping

• Daily logs of autoclave operations are usually required. Include information such as date, time and operator for both the loading and unloading process. Also include, if required, the manual temperature and pressure readings taken during the process.
  Document all testing performed on the autoclave. Other suggested documentation includes training for all operators, installation dates and times and any inspections performed by outside agencies such as fire marshals or boiler inspectors.
  Documentation of any failed test should be followed by documentation of repairs performed and tests conducted to confirm the autoclave is working properly.
  All records concerning the autoclave should be maintained for at least three years.