Seminar to Help Manufacturers Accelerate the Process of Bringing Reusable Medical Devices to Market

Medical product manufacturers can learn how to accelerate the process of bringing their reusable devices to market in a day-long seminar on May 3, 2011, in Dedham, Massachusetts.

Titled “Bringing Your Reusable Device To Market: Just Because Your Device Lasts Forever Doesn't Mean The Process of Bringing It To Market Has To,” the seminar will provide an extensive look at the process of introducing such products and help manufacturers answer critical questions such as: “What is required?”; “How much will it cost?”; and “How long will it take?”

The seminar will cover the product introduction process from manufacture of the sterilization tray to the testing that’s required for regulator submittal. Presentations will include:

• Flushing It Out: New Analytical Methods of Testing on Protein, Hemoglobin, and Carbohydrate

• Don’t Get Stuck in a Groove: Cleaning Validations Using Microbial Methods

• What is the Good in Good Laboratory Practices (GLP): Understanding the Process

• Packaging Your Idea Into Reality: A Look at the Process of Tray Manufacturing

• One Cycle, Two Cycle, Three Cycle, More?: Sterilization of Your Reusable Devices

The event will run from 8:30 a.m. to 3:30 p.m., with registration and a complimentary continental breakfast starting at 8 a.m. The seminar will be held on Tuesday, May 3, 2011, at the MIT Endicott House, 80 Haven Street, Dedham, Massachusetts. The cost is $149 per person and it includes breakfast, lunch, and workshop handouts.

The seminar is sponsored by Microtest Laboratories, a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries.

To register, contact Julie Adamski at 413-786-1680, toll-free at 800-631-1680, or at jadamski@microtestlabs.com.

About Microtest Laboratories

Microtest Laboratories is a leader in testing services and contract manufacturing 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.

White Paper Outlines Disinfection Testing, Cleaning Validation Studies Requirements for Reusable Medical Devices

AGAWAM, MASS. – A new, free white paper outlining the application of disinfection and cleaning validation requirements for reusable medical devices in line with U.S. Food and Drug Administration (FDA) regulations is now available from Microtest Laboratories (http://www.microtestlabs.com/medical-disinfection-paper).

Titled “Reusable Medical Device Disinfection and Cleaning Validation Requirements,” the 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 author of the paper is Steven Richter, Ph.D., president and scientific director of Microtest Laboratories. Richter is himself a former FDA official.

“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,” Dr. Richter notes.

“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.

“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.

“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.

“This new white paper is aimed at helping practitioners determine the best practices for performing these critical disinfection testing and cleaning validation studies,” Dr. Richter states.

Download a free copy of the white paper “Reusable Medical Device Disinfection and Cleaning Validation Requirements” from http://www.microtestlabs.com/medical-disinfection-paper.

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.

About Microtest Laboratories

Microtest Laboratories 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 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.

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Press Contact: Don Goncalves, 781-793-9380, dgoncalves@tizinc.com

Keywords: Cleaning validation studies, Disinfection testing, Reusable Medical Devices