Type 2 PCDs

Mesa’s Most Resistant PCDs

Mesa’s Process Challenge Devices (PCD) are designed to help medical device manufacturers and contract sterilization providers efficiently and accurately confirm EO sterility assurance. All PCDs are identified by a N.X nomenclature. The N prefix delineates the polymeric film/pouch specification called a PCD ‘Type’. This type is indicative of a specific EO resistance range. The .X…

PCDs

Confirming EO Sterility with PCDs

Mesa’s Process Challenge Devices (PCD) are designed to help medical device manufacturers and contract sterilization providers efficiently and accurately confirm Ethylene Oxide (EO) sterility assurance. Our convenient to use test pack replacement device provides greater EO resistance than almost all medical devices in most EO process cycles. Mesa’s PCD products are packaged in a controlled…

Run a CI

Daily Sterilizer Monitoring Protocol

  Frequently, dental practices and other healthcare facilities wonder: are there any tests that I can perform in between my weekly biological indicator (spore test)? Yes, according to the Centers for Disease Control & Prevention: Use mechanical, chemical, and biological monitors according to the manufacturer’s instructions to ensure the effectiveness of the sterilization process (IB).…

The Dental Profession is Changing

DSOs Becoming More Popular

Dentists are increasingly joining dental service/support organizations (DSOs) than ever before. Solo dentists are in decline and it appears that they will continue to do so. Researchers have found that 8.3% of dentists are affiliated with DSOs in 2016, up from 7.4% in 2017.1 Dentists are also starting to shift in age and sex. Younger…

EtO Sterilization

EtO Sterilization

Most sterilization in the medical device industry is accomplished by way of heat, usually in the form of steam. A significant alternative to heat-only processing methods is ethylene oxide (EtO) sterilization. As alluded to, this process is usually performed on heat- or moisture-sensitive items. EtO sterilization uses both temperature (30°-70°C) and the presence of the…

What to do After a Failed Spore Test

If you have ever had a spore test fail and continue to use the failed autoclave, you have options. One such option is running a sterilization cycle with a ProChem SSW Integrator.  ProChem SSW Steam Sterilization Integrator is a single-use Class 5 Integrating Indicator which complies with ANSI/AAMI/ISO 11140-1:2005 and ANSI/AAMI ST60:1996. It integrates three…

Verifying the Design

Design Verification

Design Verification is the next required step in the design process. Verification is literally an examination of evidence to prove the predetermined requirements have been met. This is an exercise done on paper, where you take all the design inputs (specifications, regulations, knowledge from previous designs, and any information required for proper function of the…

Evaluating the Design

Design Review

The next requirement for the design process is the Design Review. This is set up as a milestone(s) during product development, and is used to evaluate the design in relation to the previously identified requirements. These checks will help to identify issues before committing to further work on the product. Per the FDAs definition in…