Industry Perspective on Reusable Medical Device Cleaning and Validation Requirements Outlined in New Management Brief

AGAWAM, MASS. — April 30, 2012 — A new management 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medical device cleaning validations and testing requirements resulting from the US Food & Drug Administration’s (FDA) draft guidance document, “Draft Guidance for Industry and FDA Staff – Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.”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 brief is available from Microtest Laboratories at http://www.microtestlabs.com/reusable-med-device-brief.

“Although the FDA guidance document is not legally enforceable, it describes the agency’s ‘current thinking and should be viewed as recommendations,’” said Steven Richter, Ph.D., president and scientific director of Microtest Laboratories — a former FDA official — and author of the brief.

In his brief titled “Reusable Medical Device Cleaning Validation and Testing Requirements (An Industry Perspective),” Richter discusses a variety of issues raised by the document which the FDA released last May for industry comment. The issues 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While Richter emphasized that “the FDA document was issued for comment and is not for implementation, the medical device industry understands that changes from current best practices will be required immediately.”

His brief seeks to “raise the industry discussion of issues that must be anticipated, discussed, and thoroughly evaluated for the time when implementation is required,” he said.

Dr. Richter founded Microtest Laboratories in 1984 after a distinguished career at the FDA. Under his leadership, Microtest Laboratories provides the medical device, pharmaceutical, and biotechnology industries with premier testing and manufacturing support.

Download a copy of the management brief, “Reusable Medical Device Cleaning Validation and Testing Requirements (An Industry Perspective),” from http://www.microtestlabs.com/reusable-med-device-brief.

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.

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New Analytical Methods on Testing Protein, Hemoglobin & Carbohydrates is Focus of Tech Presentation at BIOMEDevice Boston, April 25

AGAWAM, MASS. — April 13, 2012 — BIOMEDevice Boston attendees will learn about new analytical methods on testing protein, hemoglobin, and carbohydrate in an Innovation Briefs Theater presentation on Wednesday, April 25, by Patrick Kenny, Director of Analytical Services at Microtest Laboratories Inc.

The focus of Kenny’s technology presentation — titled “Flushing It Out” and of interest to anyone who is bringing a device to market — will include:

• Regulations and Guidance, Background, Cleaning Validation Purpose

• Why Chemical Tests?

• Why Protein, Hemoglobin, and Carbohydrates

• Method Detection Limit vs. Device Detection Limit

• Validation Testing

• Test Soil

• Spiking Location

• Extraction

• Residual Protein, Hemoglobin, and Carbohydrate Assays

Flushing It Out will be presented at 12 p.m., Wednesday, April 25, in the Innovation Briefs Theater, Booth 1051, at BIOMEDevice Boston. Admission is free with BIOMEDevice Boston admission credentials. No reservations are needed.

Kenny has over 14 years of laboratory experience, including five supervising the Analytical Chemistry department at Microtest Laboratories, a leader in medical device testing and related services for the medical device, pharmaceutical, and biotechnology industries. Kenny holds BS and MS degrees in chemistry and is the author of numerous articles, including the white paper, "Five Steps to Validating the Cleaning Process of Medical Devices," available for download at http://www.microtestlabs.com/cleaning-validation-paper.

Kenny’s lab routinely performs cleaning validations on reusable and one-time use medical devices. In addition to medical device testing, the lab performs analysis of pharmaceutical drug products and combination products in support of all phases of development.

For more information, visit Microtest Laboratories at BIOMEDevice Boston in booth 1023, April 25-26, 2012. Or, visit Microtest’s web site at http://www.microtestlabs.com or call
1-413-786-1680, or toll-free 1-800-631-1680.

About Microtest Laboratories

Microtest Laboratories is a leader in medical device testing and related services for the medical device, pharmaceutical, and biotechnology industries. 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 Microtest Laboratories on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

“Proposed Changes to 21CFR 610: The New Scope of Biologics Sterility Testing” is Subject of New Management Brief

AGAWAM, MASS. – April 4, 2012 – The new scope of biologics sterility testing, resulting from the U.S. Food and Drug Administration’s (FDA) proposed changes to 21 CFR 610, is discussed in a new management brief from Microtest Laboratories. Download the brief from http://www.microtestlabs.com/21-cfr-610-paper.

The FDA’s proposed amendments to 21 CFR Parts 600, 610, and 680, published in the Federal Register on June 21, 2011, for review and comment, are focused on expanding the scope of the current sections to allow for greater flexibility in testing methodology.

“Through these changes, the FDA is embracing the emergence of new non-culture based technologies. If approved, they will provide the opportunity to utilize these methods as alternatives to culture-based sterility tests,” explains James E.T. Gebo, B.S., M.P.A., RM (NRCM), Technical Representative, Laboratory Services, Microtest Laboratories, in the brief, “Proposed Changes to 21CFR 610: The New Scope of Biologics Sterility Testing.”

“The most significant proposed revision is the elimination of the specified sterility test methods,” writes Gebo. “But while the proposed changes seem extreme at first glance, in the grand scheme they are beneficial for all interested parties.”

The brief discusses the potential benefits, including the opportunity for manufacturers and quality control laboratories to streamline their testing and adopt new emerging sterility test technologies — such as rapid testing methods employing PCR — that will further support the drive to achieve quicker product release.

Download the new free management brief, “Proposed Changes to 21CFR 610: The New Scope of Biologics Sterility Testing,” at http://www.microtestlabs.com/21-cfr-610-paper.

About Microtest

Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, U.S.A., the company’s expertise and flexible processes 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 Microtest Labs on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.