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Sterilization in Medical Devices

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10 Questions

What is the level of decontamination required for all reusable invasive medical devices?

Sterilization

What is the main advantage of gas plasma sterilization?

Rapid throughput

Which sterilization method uses normal pressure?

Dry Heat

What is a characteristic of ideal sterilization methods?

Rapid throughput and easy validation

Which sterilization method is capable of processing items at sub-atmospheric pressure?

Ethylene Oxide

What is the primary purpose of sterilization in medical devices?

To completely destroy microorganisms including bacterial spores

Which of the following sterilization methods is most similar to an oven?

Dry heat sterilization

What is the approximate cycle time of steam sterilization?

40–60 minutes

Which of the following sterilization methods uses both thermal energy and chemical processes?

Low temperature steam and formaldehyde vapor sterilization

What is the primary advantage of sterilization methods with rapid throughput?

Increased ease of validation

Study Notes

Sterilization Methods

  • Sterilization is the complete destruction of microorganisms including bacterial spores.
  • It is required for all reusable invasive medical devices (RMD).

Ideal Sterilization Methods

  • Should have rapid throughput.
  • Should be easily validated.
  • Should be capable of processing wrapped items to enable storage after processing without environmental contamination.

Thermal Energy (Heat) Sterilization Methods

  • Steam (moist heat) at high pressure: cycle time approximately 40-60 minutes.
  • Dry Heat, similar to an oven, using normal pressure: cycle time up to 2 hours.

Low Temperature Chemical Sterilization Methods

  • Gas plasma at ambient temperature: cycle time 45-75 minutes.
  • Ethylene Oxide (EO) at sub-atmospheric or high pressure.
  • Low temperature steam and formaldehyde vapor: cycle time unknown.

Sterilization Methods

  • Sterilization is the complete destruction of microorganisms including bacterial spores.
  • It is required for all reusable invasive medical devices (RMD).

Ideal Sterilization Methods

  • Should have rapid throughput.
  • Should be easily validated.
  • Should be capable of processing wrapped items to enable storage after processing without environmental contamination.

Thermal Energy (Heat) Sterilization Methods

  • Steam (moist heat) at high pressure: cycle time approximately 40-60 minutes.
  • Dry Heat, similar to an oven, using normal pressure: cycle time up to 2 hours.

Low Temperature Chemical Sterilization Methods

  • Gas plasma at ambient temperature: cycle time 45-75 minutes.
  • Ethylene Oxide (EO) at sub-atmospheric or high pressure.
  • Low temperature steam and formaldehyde vapor: cycle time unknown.

Learn about the importance of sterilization in medical devices, including the ideal methods and requirements for reusable invasive medical devices.

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