1) What are the benefits of using disposable medical products versus their reusable counterparts?

Safety: Provides maximum protection against cross infections, material degradation of conventional reusable products and toxic residual release such as endotoxins and prions.

Efficacy: Enhances the reliability of devices’ performance and functionality. Consistent mechanical and surface properties with convenient packaging.

Cost Effectiveness: Reduces purchasing cost for reprocessed SUDs and new devices. Minimising expenditure for risk analysis, pre-cleaning and collection cost, logistics and personel training.

Ethical Aspects: Allows for patients’ informed consent, equal health-care services and allocation of scarce resources in the medical work.

Legal Aspects: Minimising the liability of reprocessed device and possible device malfunction. Allows better market competition and device cost reimbursement.

Environmental Aspects: Less water and energy use compared to reusable product use. Our medical grade raw material also ensures highly biodegradable product waste. 

 

2) What are the international production standards that we strictly adhere to? 

  • ANZI/AAMI/ISO 11135:1994 – Medical Devices – Validation and routine control of ethylene oxide sterilization.
  • EN550 : 1994 Sterilization of medical devices – Validation and routine control of ethylene oxide sterilization.
  • US FDA Federal Register – Ethylene oxide, Ethylene Chlorohydrin and Ethylene glycol; Proposed Maximum Residue Limits and Maximum Levels of Exposure, 23rd June 1978, Part V.
  • ISO EN 10993 – 7: 1996 Biological evaluation of medical devices – Ethylene oxide sterilization residuals.
  • USP 24:2000 Product Sterility Testing
  • ISO 11737-1:1995 Sterilization of Medical Devices-Microbiological Methods – Part 1
  • ISO 11138 and EN 866

 

3) How do we ensure the consistency of our products?

Our company is committed to quality in all aspects of our operations. To ensure the consistency of our products, they are put through stringent validation process and quality check before being dispatched to our customers. We provide you with a diverse range of products that are made using quality raw materials, including medical grade resins, and are put through International Standard manufacturing and assembly processes. After which they are sterilised using ethylene oxide (ETO).

Tests that we use:

  1. Physical Performance
  • Cycle Parameters
  • Temperature Profiles
  • Functional Test
  • Packaging Test

   2. Microbial Performance

  • Process Challenge Device Test
  • Internal Biological Indicator
  • External Biological Indicator

    3. Ethylene Oxide (EO) Residual

  • EO Residual Test
  • ECH Residual Test