Best Practices of Medical Device Reprocessing

  • Healthcare Associated Infections (HAI’s) are the most common complication affecting patients in Hospitals. Patient safety and best practice start in the CSSD. Many SSIs can be prevented with practices that help mitigate the numerous risk factors contributed by the patient or the environment. A surgical care process provides a systematic approach to support implementation of evidence-based, effective strategies to manage modifiable risk factors and improve surgical outcomes.

  • Cleaning & Disinfection

    CDC Recommends:

    • Use cleaning agents that are capable of removing visible organic and inorganic residues.
    • Clean medical devices as soon as practical after use because soiled materials become dried onto the instruments.
    • Testing should be performed to assess efficacy of cleaning of medical devices.
  • Sterilisation & Monitoring

    CDC Recommends:

    • Use mechanical, chemical and biologic monitors to ensure the effectiveness of the sterilisation process.

    AAMI Recommends:

    • A biological indicator (BI) within a process challenge device (PCD) should be used for weekly*, preferably daily routine efficacy testing and in every load containing implants. Loads containing implants should be quarantined until the BI results are known.

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Collaborating for Patient Safety - Infection Preventionists and CSSD


Medical Device Reprocessing SOP


Performing a risk analysis in CSSD

  • In a CSSD department, there are numerous risks such as improper cleaning, steriliser loading, cycle selection, or even a steriliser malfunction. Extended steam sterilisation cycles still trouble many CSSDs, as do loaner sets. The decontamination process is constantly becoming more difficult. A CSSD is faced with instrumentation that is difficult to clean because of long narrow lumens, intricate designs, inaccessible lumens and new materials. In CSSD a risk analysis should be performed to prevent infections and enhance patient safety.

Human Error

  • Incorrect use and interpretation of monitoring tools
    • Not determining that the physical monitors were correct for the load
    • Not identifying that the incorrect cycle was run for the load contents
    • Using the wrong BI or test pack/PCD for the load
    • Using the wrong Class 5 integrating indicator test pack/PCD used for the load
    • Not following the BI test pack/PCD or Class 5 integrating indicator instructions for use
    • Incorrect reading of Class 5 integrating indicator or BI result
    • Using the wrong internal chemical indicator for the cycle
    • Incorrect reading of internal chemical indicator
    • Incorrect storage of any chemical or biological indicators
    • Not following the container or instrument/container manufacturer's instructions for use
    • Not verifying instrument/container manufactures sterilisation parameters for use in your sterilisers using AAMI product testing protocol
    • Incorrect packing or container system for the cycle parameters
    • Not correctly preparing the container for use (i.e., filters and valves or appropriate bottom tray)
    • Using a peel pouch, woven or non-woven wrap, or towel in a gravity 270°F to 275°F (132°C to 135°C), three-minute cycle
    • Not using a mesh bottom perforated tray that allows air removal and steam penetration
    • Placing a folded peel pouch inside another peel pouch
    • Preparing textile packs that are too dense to sterilise in the cycle parameters chosen
    • Not placing basins in same direction
    • Not using non-linting absorbent material between nested basins
    • Using canisters with closed lids
    • Not disassembling or opening hinged instruments or surgical supplies
    • Not holding packaging materials at 68°F-73°F (20°C-23°C), 30-60% RH for two hours prior to use
    • Stacking containers systems if not recommended by manufacturer
    • Stacking perforated instrument trays
    • Not laying instrument trays flat or parallel to the shelf
    • Laying peel pouches flat instead of on edge, not properly spaced or with plastic sides not facing one direction
    • Not placing basins on edge
    • Not placing fabric packs on edge
    • Placing packages too close to each other impeding air removal and sterilant penetration around and through load

Poor Steam Quality or Quantity

    • Improperly insulated steam lines
    • Malfunctioning trap in steam line
    • Malfunctioning or no drain check valve
    • Steam contact with a cold load
    • Steam pressure too high for the temperature
    • Too much water in steam produced at boiler (dryness should be between 97% and 100%)
    • Improper chamber heat up
    • Desiccated packaging materials (e.g., towels)
    • Steam pressure too low for the temperature
    • Excessive reduction of steam pressure too close to steriliser
    • Faulty steam control valve
    • Faulty pressure reducer control valve
    • Inadequate vacuum or vacuum depth or other air removal system
    • Clogged chamber drain line, strainer or chamber drain screen
    • Clogged vent lines
    • Leak caused by a faulty door gasket
    • Leak in other areas of chamber
    • Plugged, faulty or maladjusted control valves (i.e., air break valve)
    • Low steam pressure
    • Low water pressure
    • Too high water temperature
    • Inadequate water supply pressure
    • Clogged water supply strainer
    • Air trapped by the load
    • Incorrect cycle parameters for the load
    • Temperature gauge out of calibration
    • Long heat-up time of large loads (i.e., heat lag)
    • Clogged chamber drain line, strainer or chamber drain screen
    • Variations in steam pressure due to clogged filter, poorly engineered piping or excessive demands on the steam supply
    • Presence of non-condensable gases in steam line and load
    • Inadequate steam supply pressure
    • Clogged steam supply strainer
    • Control timer out of calibration
    • Inappropriate cycle parameters for the load being processed
    • Come up time less than 1.5 minutes in a gravity 270°F to 275°F (132°C to 135°C) 3 minute cycle
    • Oversized load
    • Variations in steam pressure due to clogged filter, poorly engineered piping or excessive demands
    • Pressure gauges and controllers out of calibration
    • Clogged steam lines
    • Clogged steam supply strainer
    • Clogged chamber drain line, strainer or chamber drain screen
    • Malfunctioning valves
    • Noncondensible gas level >3.5% by volume
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