HUMAN MEDITEK CO., LTD.
Q : Is it possible to use the pouch of EtO and steam sterilizer to plasma sterilizer? If not, please let me know the details of the pouch for HMTS series.
A : 1) What is the Tyvek® Pouch for HMTS series?
:Tyvek® has introduced new way for protection, security and safety in a wide variety of industries, including protective apparrel, construction, envelopes, medical packaging and graphics.
Being made of very fine, high-density polyethylene fibers, Tyvek® offers the best characteristics of paper, film and fabric in one material. This unique balance of properties, which cannot be found in any other materials, makes Tyvek® lightweight but strong; vapor-permeable, but water-, chemical-, puncture-, tear- and abrasion-resistant. Tyvek® is also low-linting, smooth and opaque.
2) Can other pouches be used for HMTS series?
: No. Any absorbent paper pouches can not be used, because the HMTS series use hydrogen peroxide as sterilizing agent.
3) How long is the sterilized item inside pouch safe and free from a contamination?
: The shelf-life or expiration date of sterilized devices and instruments is the period during which an item is considered safe for use. Although, the issue of the shelf-life has been addressed by several organizations including the Centers for Disease Control and Prevention (CDC), Association of Operating Room Nurses (AORN), the Association for the Advancement of Medical Instrumentation (AAMI), and the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), no organizations can make specific recommendations regarding the shelf-life of the sterilized items. Most facilities have adopted event-related shelf-life practices versus placing expiration dates on packages.
Event-related packaging or shelf-life is a storage practice that recognizes that the package and its contents remain sterilzed until some event (e.g., the packaging becomes wet or torn) causes the item(s) to become contaminated. Instead of placing an expiration date (i.e., time-related) on the package, an indefinite shelf-life label with the date of sterilization is placed on the package. Placing the date of sterilization facilitates the retrieval of processed items in the event of a sterilization failure. In addition to other labeling requirements the package label should contain the following statement (or similar wording): “indefinite shelf life unless integrity of the package is compromised”. While is it acceptable to have both event-related and time-related shelf-life policies, it is recommended to choose one system or the other for uniformity and to avoid confusion in the clinic. With either method, inspect all packages at the time of use and if the packaging is compromised (e.g, torn, wet, punctured), do not use the item(s). The item(s) must be repackaged and re-sterilized before use.
4) What is the sealing temperature of the Tyvek® pouch?
: 115 ∼ 130 ℃
5) How are the packed medical devices and instruments loaded in the chamber?
: They should be positioned uniformly (a vertical layer) for effective diffusion of the vaporized sterilizing agent and please avoid stacking on each other in the chamber.
6) What is the recommended method to use the chemical indicator strip?
: Chemical indicator strip should be placed inside each pouch to identify the medical devices and instruments are processed or not.