New White Paper Assists Medical Device Manufacturers with Changes to FDA Endotoxin Testing Guidelines

 AGAWAM, MASS. —October 24, 2012 — A new white paper is available to assist medical device manufacturers with understanding recent changes to the U.S. Food and Drug Administration’s (FDA) thinking regarding endotoxin testing. The paper is available to download from the Web at http://www.microtestlabs.com/medical-device-endotoxin-testing-paper.

Titled “FDA Updates Medical Device Endotoxin Testing Program (New Guidance),” the new white paper is authored by Steven G. Richter, Ph.D., a former FDA official, and President and Chief Scientific Officer of Microtest Laboratories, Inc., a leading contract testing laboratory.

In the paper, Dr. Richter discusses the FDA’s recently published document, “Guidance of Industry Pyrogen and Endotoxin Testing: Questions and Answers.” The FDA document replaced the agency’s 1987 Endotoxin Guidelines — now considered out of date as a result of changes in the USP and pharmaceutical dosage forms. It presents the agency’s current position regarding pyrogen and bacterial endotoxin testing requirements for pharmaceuticals, biologics, and medical devices. Medical devices that contact circulating blood or cerebrospinal fluid, or are used with intraocular products or in vitro fertilization procedures, are required to be endotoxin-free.

In his new white paper, Dr. Richter reviews the FDA’s updated guidelines on endotoxin testing and explains how they relate to medical devices. Since the majority of pyrogens found on medical devices are bacterial in nature, the paper focuses on those contaminates.

Some medical devices that are required by the FDA to be tested for endotoxin are:

•       Intravenous catheters and tubing

•       Cardiac stents and angioplasty balloons

•       Certain implants such as pacemakers/defibrillators

•       Spinal catheters

•       Transfusion catheters

•       Intraocular lens implants

•       Cranial drills

•       Perfusion tubing

•       Dialysis tubing and filters

•       Vascular grafts

•       In vitro fertilization catheters

Download a copy of the new white paper, “FDA Updates Medical Device Endotoxin Testing Program (New Guidance),” from the Microtest Laboratories website at http://www.microtestlabs.com/medical-device-endotoxin-testing-paper. Or, request a copy by calling 1-413-786-1680 or toll-free 1-800-631-1680.

About Microtest Laboratories

Microtest Laboratories is a full-service medical device testing laboratory and provider of related services for the medical device, pharmaceutical, and biotechnology industries. Medical device 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.

Based in Agawam, Massachusetts, USA, the company provides expertise and flexible processes that enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com, or call 1-413-786-1680 or toll-free 1-800-631-1680. Follow on Twitter at http://twitter.com/MicrotestLabs.

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New Scope of Reusable Medical Device Cleaning Validations is Examined in New White Paper from Microtest Laboratories

AGAWAM, MASS. – October 2, 2012 – The new scope of cleaning validations for the manufacturers of reusable medical devices is examined in a white paper available for download from http://www.microtestlabs.com/new-scope-cleaning-validation-paper.

“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 Patrick Kenny, Manager of Analytical Services, Microtest Laboratories.

In the new white paper, “The New Scope of Reusable Medical Device Cleaning Validations,” Kenny 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,” Kenny notes.

The paper discusses cleaning validation analytical assays as well as various methods and scenarios related to performing the validation. Recommendations are based on several key documents relating to reusable device cleaning validations that are either in draft or final form. They include AAMI document TIR30:2003, a comprehensive guide to medical device cleaning validations. TIR30 is currently in revision, and an updated version is scheduled for 2011 release.

Download the white paper, “The New Scope of Reusable Medical Device Cleaning Validations,” from the Microtest Laboratories website at http://www.microtestlabs.com/new-scope-cleaning-validation-paper.

Kenny holds a M.S. degree in Chemistry and has spent the past 13 years working in QC, R&D and manufacturing laboratories. At Microtest, Kenny leads the services group performing medical device and pharmaceutical analytical testing for companies worldwide.

About Microtest Laboratories

Microtest Laboratories is a full-service medical device testing laboratory and provider of related services for the medical device, pharmaceutical, and biotechnology industries. Medical device 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.

Based in Agawam, Massachusetts, USA, the company provides expertise and flexible processes that enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com, or call 1-413-786-1680 or toll-free 1-800-631-1680. Follow on Twitter at http://twitter.com/MicrotestLabs.