Decontamination is the process of cleaning and disinfecting used medical devices so that they may be reused or tested by engineers. But before the used device is handled by anyone, it is required by law that it be decontaminated to ensure safety of the staff. To perform this task, the company must have the necessary certifications and follow the set guidelines to reduce the risk of exposure to bio-hazardous material such as blood, body tissue, etc. If it does not possess the capabilities to perform the task in-house, the company must then outsource the activity.
There are three levels/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:

  • Cleaning (Low level – Level 1)
  • Disinfecting (Intermediate level – Level 2)
  • Sterilization (High levelLevel 3)


This is the first and most important step in the decontamination process and 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.


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)


Through the application of high levels of heat the highest level of decontamination can not only kill disease causing microorganisms but also eliminates transmissible agents such as spores and bacteria. The different methods of sterilization include:

The sterilization method chosen is based on the device’s ability to withstand heat and extent of sterilization required. For example 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. In addition to ISO 13485 (Quality Management System Guidelines), some of the relevant sterilization standards to be adhered to are:

  • 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 desire sterility levels have been obtained. This is done through the use of Biological Indicator Testing and Chemical Indicators.

Packaging/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:

  1. Watertight Primary Receptacles
  2. Watertight Secondary Receptacles
  3. Absorbent Material
  4. Sturdy Outer Packaging