Medical devices that are in contact with human tissues represent a significant risk of infection and cross-contamination if not properly sterilized. Ensuring sterility for single-use, reusable, or ready-to-sterilize devices is critical for patient safety and regulatory compliance.
Manufacturers must evaluate sterilization methods during the development phase to meet international and local standards. This guide provides an overview of sterilization methods, applicable international standards, and key regulatory requirements for registering sterile medical devices in Mexico.
Sterilization Methods
Sterilization of medical devices is an essential step to eliminate microbial contamination and ensure device safety. The most common methods include:
- Moist Heat (Steam): Effective for heat-resistant materials, widely used in autoclaving.
- Dry Heat: Suitable for moisture-sensitive devices.
- Radiation (Gamma, E-Beam): Penetrates packaging, ideal for single-use devices like syringes and catheters.
- Ethylene Oxide (EtO): A low-temperature gas sterilization method, particularly useful for polymers, multi-layer packaging, and complex devices (e.g., catheters, stents).
- Vaporized Hydrogen Peroxide & Chlorine Dioxide: Used for sensitive electronics and heat-labile materials.
The critical role of EtO
EtO sterilization is one of the most widely used methods due to its compatibility with a broad range of materials, including plastics, metals, and glass. However, manufacturers must validate residual limits in compliance with ISO 10993-7 to ensure patient safety.
International Standards for Sterilization
To ensure sterility and regulatory compliance, manufacturers must adhere to internationally recognized standards, including:
- ISO 11135: Validation and routine control of EtO sterilization.
- ISO 17665: Moist heat sterilization (e.g., autoclaving).
- ISO 11137: Radiation sterilization.
- ISO 11607: Packaging requirements for sterile medical devices.
And additionally:
- ISO 20417 & ISO 15223-1: Standardized symbols and labeling (applicable items for sterile products).
Compliance with these standards streamlines submission for registration in Mexico
COFEPRIS Requirements for Sterile Medical Devices
To obtain sanitary registration in Mexico, MHA must submit detailed documentation on sterilization processes, including:
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Sterilization Process Overview
– Description of the method (e.g., EtO, gamma radiation).
– Validation summary confirming a Sterility Assurance Level (SAL) of 10⁻⁶.
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Sterility Report & Certificate
– Microbiological test results, certified by the responsible evaluator.
– For EtO sterilization, residual testing reports (ethylene oxide and ethylene chlorohydrin levels).
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Reusable Device Requirements
– Evidence that the device maintains its performance after repeated sterilization cycles.
– Clear instructions on re-sterilization methodology and maximum allowable cycles.
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Labeling & Instructions for Use (IFU)
– NOM-137-SSA1-2008 indicates that labels requirements must specify:
– Sterilization method (e.g., “Sterilized with Ethylene Oxide”).
– Whether the product is single-use or reusable.
– IFUs must include sterilization/reprocessing instructions (in Spanish).
Conclusion
Sterilization is a critical factor in medical device safety and regulatory compliance. Manufacturers must carefully select and validate their sterilization methods while ensuring full adherence to and international standards and COFEPRIS requirements for registration in Mexico.
For expert guidance on sterilization validation, regulatory strategy, and local submissions, contact our team at contact@veraqueconsulting.com to ensure a smooth path to market approval in Mexico.
