FDA Medical Device Sterilization

Medical Device Sterilization: To avoid disease transmission linked with the use of an item, sterilization destroys all microorganisms on its surface or in a fluid. Either a physical or chemical process that destroys or removes all microbial life in a specific area, including spores.

 

Sterility: the reduction of anticipated levels of contamination in a load to the point where the probability of survival is less than 10^-6. This is referred to as sterility assurance level (SAL)

Devices labeled as sterile are subject to industrial terminal sterilization processes based on microbial inactivation. Commonly used sterilization methods are:

• Established Category A
• Established Category B
• Novel Methods

 

Established Category A: This has a long history of safe and effective use demonstrated by:

1. Ample literature,
2. Clearances of 510(k)s or approvals of PMAs
3. Satisfactory Quality Systems inspections
4. FDA recognized standards for development, validation, and routine control.

Examples of these Established Category A:

• Dry heat
• Ethylene oxide (EO) in a fixed, rigid chamber
• Moist heat or steam
• Radiation (e.g., gamma, electron beam)

 

Established Category B: There are other methods for which.

1. There are no FDA-recognized dedicated consensus standards.
2. There is published information on development, validation, and routine control.
3. FDA has previously evaluated sterilization development and validation data for specific sterilizers using discrete cycle parameters and determined the validation methods to be adequate.

Examples of Established Category B Sterilization Methods:

• Hydrogen peroxide (H2O2)
• Ozone (O3)
• Flexible bag systems (e.g., EO)

 

Novel Sterilization Methods — newly developed methods for which there is.

1. Little or no published information,
2. No history of comprehensive FDA evaluation of sterilization development and validation data through an FDA-cleared 510(k) or approved PMA for devices sterilized with such methods.

1. No FDA-recognized dedicated consensus standards on development, validation, and routine control. FDA has not reviewed and determined to be adequate to effectively sterilize the device.

Examples of Novel Sterilization Methods:

• Vaporized peracetic acid
• High-intensity light or pulse light
• Microwave radiation
• Sound waves
• Ultraviolet light

Sterilization Information for Devices Labeled as Sterile

 For the sterilization method:

1. Sterilization method description; (e.g., gamma irradiation, ethylene oxide)
2. Chamber description, if not rigid (i.e., bag)
3. For Established B:

• for a cleared sterilizer, 510(k) number, make, model, and cycle altered?
• if the sterilizer is not cleared, this should be stated.
• if the sterilization method has been reviewed: the 510(k)/PMA/HDE number or Device Master File containing the validation evaluation. And have the cycles been altered?

1. The sterilization site.
2. The dose for radiation; (e.g., 25 kg)
3. For chemical sterilant, the maximum residue levels and a justification (e.g., EO limit based on 10993-7; what does it contact, and for how long)

 

Reusable Instrument:

1. Reusable medical devices initially supplied as sterile, requiring reprocessing for subsequent use.
2. Reusable medical devices initially supplied as non-sterile, requiring initial processing, and reprocessing for subsequent use.
3. Reusable medical devices to be reused only by a single patient, requiring reprocessing between each use.
4. Single-use medical devices supplied as non-sterile, requiring processing before use.

Examples of Novel Sterilization Methods:

• Cleaning and microbial processing

 

Moist Heat (steam) – ANSI/AAMI/ISO 17665-series Sterilization of health care products: Moist Heat – Requirements for development, validation, and routine control of a sterilization process for medical devices

 

Ethylene Oxide (rigid chamber) – ANSI/AAMI/ISO 11135 Sterilization of Healthcare Products: Ethylene Oxide – Requirements for the development, validation, and routine control of a sterilization process for medical devices

 

Radiation – ANSI/AAMI/ISO 11137-series Sterilization of health care products – Radiation – Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices, and Parts-2 and -3.

 

Dry Heat – ANSI/AAMI/ISO 20857 Sterilization of health care products – Dry heat – Requirements for the development, validation, and routine control of a sterilization process for medical devices

 

(Almost) Everything Else – ANSI/AAMI/ISO 14937 Sterilization of Healthcare Products – General requirements for characterization of a sterilizing agent and the development, validation, and routine control of a sterilization process for medical devices

PowerPoint Presentation (fda.gov)

Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile – Guidance for Industry and Food and Drug Administration Staff (fda.gov)

Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling – Guidance for Industry and Food and Drug Administration Staff (fda.gov)