Medical Device Disinfection Validations

Reusable Medical Device Validations

Manufacturers of reusable medical devices have the responsibility to provide cleaning and disinfection instructions for the product. Following the manufacturer's instructions for use (IFU), customers do cleaning and disinfection operations between each use. FDA requires all reusable medical devices to have cleaning and disinfection validations to ensure the two processes are both effective.

Disinfection Validations for Reusable Devices

Medical Device Disinfection Validations are used to validate manufacturer's instructions for the disinfection steps to show the microbicide process is effective. Disinfection validation studies should look at "worst case" scenarios to prove devices can be reliably disinfected by end-users when instructions are followed.

Type of Disinfection Validations

Disinfection is defined as using physical or chemical methods to kill microorganisms. This is frequently accomplished through the use of chemical disinfectants, or via thermal disinfection.

• Chemical Disinfection

Depending on the lever of disinfection required, validations of chemical disinfections are performed differently to support high-level disinfection, intermediate-level disinfection and low-level disinfection. The level of disinfection is determined by the category of the device (critical, semi-critical or non-critical). These validations require that the device be inoculated with bacteria and then soaked in the liquid chemical germicide solution. Any remaining bacteria is extracted from the device and grown on plates in a manner similar to a bioburden test.

1. High-Level Disinfection Requires:

• 6-log reduction of Mycobacteria.

2. Intermediate-Level Disinfection Requires:

• 6-log reduction of Klebsiella pneumoniae.
• 6-log reduction of Pseudomonas aeruginosa.
• 6-log reduction of Staphylococcus aureus.
• 6-log reduction of Escherichia coli.
• 3-log reduction of Mycobacteria.

3. Low-Level Disinfection Requires:

• 6-log reduction of Klebsiella pneumoniae.
• 6-log reduction of Pseudomonas aeruginosa.
• 6-log reduction of Staphylococcus aureus.
• 6-log reduction of Escherichia coli.
• Thermal Disinfection

Thermal disinfection employs hot water temperatures of 60°C to 95°C (140°F to 203°F). The level of thermal disinfection depends on the exposure time and exposure temperature.

STEMart offers professional Disinfection Validations services for reusable medical devices to assurance that your products meet FDA's disinfection validation requirements, ensuring your products safety, as well as patient safety. Our validation processes are in compliance with AAMI TIR12, ANSI/AAMI ST58, ISO 15883 series, ISO 17664, and FDA guidance documents.

STEMart will not only help you validate a given procedure, but will provide advice in designing and creating protocols for your reusable devices.

If you have additional questions about Medical Device Disinfection Validations or would like to find out more about our services, please feel free to contact us.