Decontamination
Decontamination is the process of cleaning and disinfecting used medical devices so that they may be reused or tested by engineers. This process requires certain certifications and adherence to strict guidelines.
Life Science Outsourcing has proven expertise in helping clients navigate the decontamination process to enhance efficiencies while ensuring all regulatory requirements are met.
Decontamination Expertise
There are three steps for decontamination, and each level is an aggregate of lower-level methods. Based on exposure to biohazardous materials, a device might not have to undergo all three levels to achieve sterility.
The levels in increasing order of intensity of are:
• Level 1: Cleaning
• Level 2: Disinfecting
• Level 3: Sterilization
Cleaning
This is the first and most important step in the decontamination process. It involves the removal, usually with a detergent and water, of both visible and non-visible soil (such as blood, protein substances, and other debris) from the surface of the medical device.
Disinfecting
In this next step, liquid chemicals are used to kill non-spore forming bacteria on the medical device. Some commonly used disinfectants would be:
- Sodium Hypochlorite (Bleach)
- Ethyl Alcohol
- Isopropyl Alcohol (70%)
- Alconox
- Liquinox
- Cidex (Glutaraldehyde)
Sterilization
Through the application of high levels of heat, the highest level of decontamination can not only kill disease-causing microorganisms, it also eliminates transmissible agents such as spores and bacteria.
The different methods of sterilization provided by Life Science Outsourcing include:
- Irradiation (Gamma or E-Beam)
- Ethylene Oxide (EtO)
- Steam Sterilization
- Dry Heat Sterilization
Life Science Outsourcing is one of the few regulated services companies to offer EtO.
The sterilization method selected is based on the device’s ability to withstand heat and extent of sterilization required.
Devices with cavities or tubular openings require low level steam sterilization, but instruments able to withstand high heat levels would qualify for high-heat steam sterilization.
Sterilization Standards
In addition to ISO 13485 (Quality Management System Guidelines), LSO adheres to other relevant sterilization standards including:
- OSHA Regulations (1910.1030) – Employee Safety & Exposure Control Plan
- ISO 17665-1:2006 – Moist Heat/Steam Sterilization
- ISO 11137-1:2012 – Radiation/Gamma Ray Sterilization
- ISO 11135-1:2007 – Ethylene Oxide Sterilization
- ISO 25424:2009 – Low temperature steam and formaldehyde method
- ISO 15882:2008 – Guidance on Chemical indicators during Sterilization
Sterility Assurance Level (SAL)
Sterility Assurance Level is defined as “the probability of a single unit being non-sterile after it has been subjected to the sterilization process.”
Once the device has been sterilized, tests are conducted to determine if the desired sterility levels have been obtained. LSO tests using both Biological Indicator Testing and Chemical Indicators.
Packaging and Transportation Guidelines
It is critical that prescribed guidelines are followed when packaging and transporting contaminated medical devices due to the biohazardous risk involved. Logistics companies and transportation organizations insist that packaging of diagnostic specimens and environmental test samples includes four basic components:
- Watertight Primary Receptacles
- Watertight Secondary Receptacles
- Absorbent Material
- Sturdy Outer Packaging
Orthopedic Decontamination
For years, the orthopedic industry has faced the problem of excess inventory in hospitals and sales representative trunk stock. No one knew what to do with product once it was returned.
Life Science Outsourcing set out to solve this problem through its Decontamination and Returns Processing service. Our unique capabilities and strategic location allow us to decontaminate via autoclave, inspect, repack and redeploy product returns quickly and inexpensively.
The program allows our clients to maximize value from underused inventory while increasing responsiveness to their sales representatives.
We provide this service to companies of all sizes who are looking to reduce field inventory and save money.
