AUTOCLAVE CERTIFICATION
Annual preventive maintenance is mandatory on autoclave (sterilizer) equipment to be in compliance with Federal/State Statutes and some 3rd Party Medical Examining Boards. Sterilization is defined by the CDC as 'a process that destroys or eliminates all forms of microbial life and is carried out in health-care facilities by physical or chemical methods.' In the veterinary industry, most of these sterilizers are considered 'Class N,' 'Downward /Gravity', 'Steam', 'non-vacuum,' autoclaves like Tuttnauer, Midmark, and Pelton Cranes. They either come in 'manual' or 'automatic' forms but all sterilize through heat, pressure, and steam. For STASIS to certify for compliance, the autoclave must 'PASS' a 'Service Report' consisting of: maintenance procedures, system functions check, chemical integrator (Class 5) sterility test, and a biological indicator (spore) sterility test. Just because a machine meets these 'compliance tests', that sometimes does not mean your equipment is clean, working properly, ready for prolonged use, or the staff is trained to handle the equipment. This becomes critical for the practice as 'manual' machines have a potential for human error, 'automatics' offer no verifiable controls, and the equipment you place inside may become damaged and remain unsterile if not checked. 'Invasive Maintenance' is still required, not on an annual basis, but if your machine 'FAILS' to meet STASIS 'Service Report' your equipment malfunctions, or is 'out of spec. with the manufacture', additional repairs will be needed. See the 'Gallery of Service' for examples of 'Invasive Maintenance.' STASIS can perform both 'Preventive Maintenance' and 'Invasive Maintenance' on an individual needs basis but all machines MUST PASS these basic functions to GUARANTEE compliance with your regulatory boards (pending all recommended repairs are completed).
Compliance Checklist
- Maintenance Procedures - Physical Inspection, Light non-invasive cleaning (external), Replace parts as needed with the 'manufacturer's maintenance kit' (gaskets/dams, cleaning solutions, filters, bellows, etc.), Intermittent maintenance, Staff training, and general check-up after a year of 'wear and tear'.
- Systems Functions Check - Verification that all machine displays and controls function as such. Record timing of machine functions (fill, sterilize, vent, drain) to monitors change over time, validate accuracy of displays with tools (gauges and thermometers), Regular maintenance gives consistent results,
- Chemical Integrator (Class 5) Sterility Test - A 'Class 5 Multiparameter Integrator' (tests that time, pressure, temperature. and steam were present) challenges the machine's ability to sterilize in chemical processes to completion.
- Biological Indicator (Spore) Sterility Test - A 'Spore Test' uses a bacteria 'Geobacillus Sterothermophilus' which are Graham Stained spores that challenges the machine not only to chemically sterilize, but physically kill bacteria verifying chamber and reservoir water is free of microbial growth.