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

AGAWAM, MASS. – April 25, 2012 – A collection of free white papers from Microtest Laboratories can help guide medical device manufacturers through the complex and changing landscape of FDA regulations governing disinfection, cleaning validation, and testing 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,” said former FDA official Steven Richter, Ph.D. — now president and scientific director of Microtest Laboratories.

Pick up the white papers at BIOMEDevice Boston from Microtest Laboratories in booth 1023

It is critical that manufacturers thoroughly understand current — and correctly anticipate future — FDA reusable medical device cleaning validations and testing requirements. To assist, Microtest Laboratories offers the following white papers and management briefs:

• “Reusable Medical Device Cleaning Validation and Testing Requirements (An Industry Perspective),” a management brief by Steven Richter. The brief discusses the potential impact on reusable medical device cleaning validations and testing requirements resulting from the US Food & Drug Administration’s (FDA) draft guidance document, “Draft Guidance for Industry and FDA Staff – Processing/ Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.”
• “The New Scope of Reusable Device Cleaning Validation,” a white paper by Patrick Kenny, manager of analytical services at Microtest Laboratories. The paper discusses cleaning validation analytical assays as well as various methods and scenarios related to performing the validation.
• “Reusable Medical Device Disinfection and Cleaning Validation Requirements,” a white paper by Steven Richter. The paper outlines the salient aspects for 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,” a white paper by Patrick Kenny, reviews medical device regulation under 21 CFR Part 820 — Quality System Regulation. The paper, Kenny presents a five-step process that provides a framework to assist medical device manufacturers in their cleaning validation efforts.

For copies of the white papers and more information, visit Microtest Laboratories at BIOMEDevice Boston in booth 1023.

Microtest Laboratories, based in Agawam, Massachusetts, is a full-service medical device testing laboratory and a leader in medical device testing and related services for the medical device, pharmaceutical, and biotechnology industries. 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.

For more information, visit Microtest’s web site at http://www.microtestlabs.com or call 1-413-786-1680, or toll-free 1-800-631-1680.