White Papers Guide Medical Device Manufacturers Through Challenging FDA Disinfection Testing & Cleaning Validation Regulations

MINNEAPOLIS – November 2, 2011 – Three white papers developed to help guide medical device manufacturers through the complex and changing landscape of FDA regulations governing disinfection and cleaning validation requirements for reusable devices are available free from Microtest Laboratories at MD&M Minneapolis, in booth 1548.

"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," said former FDA official Steven Richter, Ph.D. — 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 both 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.

Microtest Labs' three white papers are:

• "Reusable Medical Device Disinfection and Cleaning Validation Requirements", 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 said.
  
  Richter's 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.
• "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 said.
  
  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
• "The New Scope of Reusable Medical Device Cleaning Validations" details the new scope of reusable medical device cleaning validations.
  
  "Cleaning validation for reusable medical devices is an important step in proving their safety. Available guidance documents now indicate that the traditional method of validating cleanliness, spore log reduction, will no longer be acceptable. Analytical assays capable of providing quantitative results will now be required instead," writes white paper author Kenny.
  
  In the paper, he notes that "although a new requirement for reusable medical devices, these tests are traditional analytical assays that are performed routinely on other types of samples. An effective protocol and report that includes justifications for the test soil and assays chosen, as well as thorough documentation of all parameters used in the validation, will help ensure success for the device's submission." He also discusses cleaning validation analytical assays as well as various methods and scenarios related to performing the validation.

Richter said, "Historically, manufacturers were not required to validate that cleaning and disinfection processes were effective in reducing microbial and protein loads to safe levels.

"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," he noted.

For copies of the white papers and more information, visit Microtest Laboratories at MD&M Minneapolis in booth 1548, Nov. 2-3, 2011. Or, visit Microtest Labs' web site at http://www.microtestlabs.com or call 1-413-786-1680, or toll-free 1-800-631-1680.

Microtest Laboratories is a full service medical device testing laboratory. Testing is performed in-house by seasoned regulatory microbiologists and chemists under strict GMP/GLP regulations. Microtest is both ISO 9000 and 17025 certified. Testing services include bioburden, sterility, endotoxin, accelerated aging, and toxicity (ISO 10993). In addition, Microtest recently introduced a fast-track test to screen plastics and polymers in medical devices for toxicity using Zebrafish embryos.