Verify Process Challenge Device - VPCD
Ref: AS 4187, EN 867-5 & ISO 17665-1, EN 285
The Verify helix is designed in Australia by NCA Laboratories, and made and manufactured in the U.K. providing quality and robustness to cope with the conditions inside the sterilizer. Made from 304L medical-grade metal and 1.5 metre or 4 metre PTFE tubing, it provides the greatest challenge for the sterilizer against the most complex cannulated lumens. A class 2 indicator is placed inside on every cycle and will detect all parameters for sterility assurance.
The well designed and built Verify helix will provide the best monitoring results for the sterility process and can be used both as a Bowie Dick Test and as a batch control on each run for all Benchtop B-Class sterilizers.
The device has a life span of 3000 cycles.
The VPCD has the capability to be a multi-purpose challenge device. The VPCD utilises the class 2 indicators on each batch of instruments, to ensure validation on each cycle. It also acts as a hybrid device, capable of hosting the biological spore test vial for your weekly validation. This places the spore tests through the toughest challenge which ensures that your sterilizer is functioning to its highest level.
Class 2 Chemical Indicators
Ref: ISO 11140-1, ISO 17665-1
Formulated in Australia by NCA Laboratories and made in the U.K.. the NCA Class 2 indicators are the only indicators in the market that can provide evidence that all critical parameters in the sterilization process have been present. Unlike the class 4,5 & 6, the class 2 indicator can detect the presence of air, which can cause blockage inside lumens and contain spore populations within the lumen. Typically mistake for a “Type 2” Indicator, the class 2 indicator detects volumes of air down to less than 1ml, which is the volume required to harvest a spore inside a lumen.
By using the class 2 indicator within the Verify Process Challenge Device (IVPCD), it provides a greater challenge to the chamber than any complex lumen instrument. It eliminates the use of biological spore testing and the use of any other indicator, cutting major costs to the practice annually.
By switching to the class 2 and the Verify, the practice is not only complying with all ASNZ, EN & ISO standards but also moving to a more reliable, sophisticated technology and confirming to best practice, protecting both the practice from liability and the patient from infection.
NCA Prime Pouches
Ref: AS 4187, ISO 11607 parts 1 & 2
The NCA Prime pouches are made in Germany with the latest tensile technology. Unlike standard cost-effective pouches, NCA sought to solve issues of breakage and monitoring for instruments being processed in the sterilizer as well as storage.
Over time, pouches wither and tear and are unreliable when providing longevity to the sterility process during storage. Pouches are typically fractured or breaches when holding sharp instruments as the pressure is pressed onto the pouches inside the sterilizing chamber. The NCA pouches have a high tensile strength which prevents sharps breaching the pack.
NCA pouches also have a longevity of 12 months as opposed to the traditional pouch post usage lifespan of 90 days. This ensures that instruments that are sporadically used can be dated and maintained in storage without being further reprocessed.
The paper is Grade A perforated which allows the free flow of steam into the pouch in one direction without allowing the air to breach the pouch. This technology is second to none in barrier systems globally and provides each facility with peace of mind when processing and storing instruments.
Traditional pouches are affixed with a class 1 process indicator. Due to lack of education in infection control monitoring, it is commonly believed that these processed indicators provide evidence of sterility. They do NOT. They simply provide evidence that the pouch has gone through the sterility process. It is not a validated result for the sterilization process. The result of the process comes from the class 2 chemical indicator. Although the class 6 indicator is not an effective monitoring tool for sterility assurance for surgical instruments, it is, however, reliable at detecting super-heated steam. Super-heated steam is generated by a sterilizer malfunction and can cause damage to the chamber such as hair-line cracks, rendering the sterilizer decommissioned. In most of these cases, a replacement sterilizer is required, costing thousands to the facility.
The NCA pouches are all affixed with class 6 indicators that can detect the presence of superheated steam in the chamber. This provides a good indication of future technical failures and can save the facility thousands of dollars on costs to repair or replace these issues. NCA is the only company who affix class 6 indicators onto this patented technology.