Microtest Laboratories has issued a management brief that discusses reusable medical device cleaning validation and testing practices in view of the FDA's own discussions and actions around development and maintenance of safe medical devices.
Specifically, the management brief discusses the potential impact on reusable medical device cleaning validations and testing requirements resulting from the FDA's draft guidance document, "Draft Guidance for Industry and FDA Staff – Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling." Although the FDA's draft guidance is not legally enforceable, "it describes the agency's 'current thinking and should be viewed as recommendations," said Steven Richter, PhD, president and scientific director of Microtest Laboratories, a former FDA official and author of the brief.
Issues discussed in the management brief include:
• "Spore tag reduction" and Hucker's soil challenges
• Cleaning methods using protein, carbohydrates, red blood cells and lipids
• Separation of cleaning, disinfectant and sterilization validation activities
• ASTM Simulated Use Test
• Three log reduction for cleaning validations
• Empirical data in 510(k) submissions
• Reducing manufacturing materials to "safe levels"
While the FDA draft guidance was issued for public comment and not for implementation, Dr. Richter said the industry must get behind efforts to change current best practices for cleaning validation and testing of medical devices.
A copy of the white paper can be downloaded for free here.
Note: Download requires free registration.
Specifically, the management brief discusses the potential impact on reusable medical device cleaning validations and testing requirements resulting from the FDA's draft guidance document, "Draft Guidance for Industry and FDA Staff – Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling." Although the FDA's draft guidance is not legally enforceable, "it describes the agency's 'current thinking and should be viewed as recommendations," said Steven Richter, PhD, president and scientific director of Microtest Laboratories, a former FDA official and author of the brief.
Issues discussed in the management brief include:
• "Spore tag reduction" and Hucker's soil challenges
• Cleaning methods using protein, carbohydrates, red blood cells and lipids
• Separation of cleaning, disinfectant and sterilization validation activities
• ASTM Simulated Use Test
• Three log reduction for cleaning validations
• Empirical data in 510(k) submissions
• Reducing manufacturing materials to "safe levels"
While the FDA draft guidance was issued for public comment and not for implementation, Dr. Richter said the industry must get behind efforts to change current best practices for cleaning validation and testing of medical devices.
A copy of the white paper can be downloaded for free here.
Note: Download requires free registration.
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