In May, the Primus Sterilizer Company received notification that their 510(k) application has been approved by the FDA. This means the updated PSS5 autoclaves can be marketed in the U.S. as medical devices. The manufacturer has classified these sterilizers as Class II equipment for use in hospital, surgical, and laboratory settings.
These newest models are substantially identical to previous versions as far as materials, construction, and software are concerned. They simply incorporate a larger chamber size. The M series can actually be installed in such a way that a filled cart will roll in and out with ease.
Vertical and horizontal doors can be selected on many of these units. Pneumatic power is standard on the larger sized machines for horizontal sliding doors. Pass-through door configurations are available upon request. Primus is also offering optional carbon steel doors (ASME approved) as part of this latest FDA approved product line.
In addition to meeting AAMI/ANSI/IEC standards, the manufacturer conforms to UL codes for safety. The software provided with each PSS5 sterilizer is designed to provide several fail-safe features. It immediately warns the end user of any malfunction. If appropriate sterilization parameters are not met, computer signals alert the operator to the failed cycle. Quality assurance at the Primus factory includes final product testing of each of these systems to ensure that they are in working condition before the unit is sold.
The product design for the new PSS5 models has also been fully tested for the ability to kill pathogens. These autoclaves achieve a Sterility Assurance Level (SAL) of 10-6. Third party testing was used to verify these results. As long as the equipment is maintained and operated correctly, hospitals and clinical facilities can rest easy about the capabilities of this equipment. Appropriate biological and chemical indicators should still be used to validate and release loads according to industry standards.
Product Use
Medical Primus sterilizers are suitable for both porous and non-porous loads. A change in chamber size can affect loading protocol. This means it is important for technicians to review their processes to prevent wet loads. All personnel using the autoclave should be required to read the instruction booklet. Primus recommends that the factory set cycles not be altered. Users who wish to alter these settings should contact the manufacturer for advice.
The laboratory models in the PSS5 line (G.1-L and M-L) can be used for media prep. These liquid pasteurization cycles should only be used for their intended purpose. The manufacturer warns specifically against using these low temperature cycles for sterilizing objects such as surgical instruments.
Multi-functional units can be used for high temperature vacuum sterilization and are available in the G.1-M and M-M models from Primus. The general purpose autoclaves from this company also offer a Test/Vac cycle for regular equipment validation using Bowie-Dick tests.
If you need a sterilizer or autoclave, you have a lot of potential choices. A number of brand new models are hitting the market and you need to know what is available. Our free report can assist you in looking past the advertising and deciding which functions you really need.
