Whitepapers Guide Device Manufacturers Through FDA Testing, Cleaning Validation Regulations

Two free whitepapers from Microtest Laboratories can help guide medical device manufacturers through the complex and changing landscape of Food and Drug Administration (FDA) regulations governing disinfection and cleaning validation requirements for reusable devices.

Reusable medical devices come in all shapes and sizes from specula to colonoscopes. Generally, these devices have expensive components that require them to be cleaned and disinfected or sterilized, says former FDA official Steven Richter, PhD, now president and scientific director of Microtest Laboratories.

Since many medical devices are made of high-tech materials such as metallic alloys or synthetic plastics, manufacturers may require the use of various chemical agents to aid in the manufacturing process, or produce contaminants that need to be removed. These devices must be cleaned to ensure patient safety and the continuing functionality of the device.

Currently, the FDA requires validation studies for both disinfection and cleaning. Both disinfection testing validation and cleaning validation studies are important to the manufacturer because they will validate the safety and efficacy of the disinfection process. It is important to qualify both the cleaning and disinfecting processes prior to validation activities.

The first whitepaper, Reusable Medical Device Disinfection and Cleaning Validation Requirements, authored by Richter, is aimed at helping practitioners determine the best practices for performing critical disinfection testing and cleaning validation studies.

Recently, the FDA began requiring additional information on 510(k) submissions, demanding clarity in the options afforded to practitioners. Microbiologists generally treat all medical devices equally, even though many devices require special treatment, Richter says.

Richters paper outlines the salient aspects of validating that a medical device can be safely reused; addresses disinfection studies and processes, rather than sterilization; and provides cleaning validation information germane to all reusable medical devices.

The second whitepaper, Five Steps to Validating the Cleaning Process of Medical Devices, by Patrick Kenny, manager of analytical services at Microtest Laboratories, reviews medical device regulation under 21 CFR Part 820 Quality System Regulation.

Several sections of Part 820 can be directly related to device cleanliness. For manufacturers, the challenge is to validate the cleaning process to ensure the devices are free of residue chemical and particulate in order to ensure patients are safe, Kenny says.

In the paper, Kenny presents a five-step process that provides a framework to assist medical device manufacturers in their cleaning validation efforts. The steps are:
1. Evaluate the process; determine the potential contaminants
2. Determine the limits
3. Identify the analytical test
4. Validate the method for use
5. Validate the cleaning process
 
Historically, manufacturers were not required to validate that cleaning and disinfection processes were effective in reducing microbial and protein loads to safe levels, Richter says. The FDA may have asked manufacturers for data regarding disinfectant use during reprocessing, but manufacturers would often simply perform cursory simulated-use tests that might not pass muster with FDA reviewers today.

Download Reusable Medical Device Disinfection and Cleaning Validation Requirements from http://www.microtestlabs.com/medical-disinfection-paper.
Download Five Steps to Validating the Cleaning Process of Medical Devices from http://www.microtestlabs.com/cleaning-validation-paper.