Navigation Links
New Scope of Reusable Medical Device Cleaning Validations is Examined in New White Paper from Microtest Laboratories
Date:11/2/2011

AGAWAM, Mass., Nov. 2, 2011 /PRNewswire/ -- A new white paper detailing the new scope of reusable medical device cleaning validations is available free from Microtest Laboratories on the Web at 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," he notes.

In the paper, Kenny also discusses cleaning validation analytical assays as well as various methods and scenarios related to performing the validation. His 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.

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.

Download a free copy of 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.

Microtest's broad portfolio of medical device and combination product testing services include sterilization validation, reusable device studies, endotoxin and sterility testing, and package validation.

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.

Available Topic Expert(s): For information on the listed expert(s), click appropriate link.

Steve Richter, Ph.D.

https://profnet.prnewswire.com/Subscriber/ExpertProfile.aspx?ei=42622


'/>"/>
SOURCE Microtest Laboratories
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Olympus Introduces Worlds First Autoclavable 5mm HD Deflectable Videolaparoscope
2. Stethocap Disposable Stethoscope Covers - a Sound Solution: ICAP Patent Brokerage Offers to Sell IP Disclosing Effective Protection for Stethoscope Heads Without Impacting Sound Transmission
3. Verathon Introduces the GlideScope AVL Reusable Video Laryngoscope;
4. Aircraft Medical Signs Multinational Distribution Agreement with Covidien for McGRATH® MAC Video Laryngoscope
5. Medicare Establishes Reimbursement for VisionCares Implantable Telescope for Macular Degeneration
6. Gastrointestinal Endoscopes - Global Pipeline Analysis, Competitive Landscape and Market Forecasts to 2017
7. Flexible Endoscope Manufacturer Determines Test Suitable for Evaluating Cleanliness of Flexible Endoscopes
8. Verathon Extends Range of GlideScope Video Laryngoscope With New Single Use - GVL 2.5 Stat for Small Children
9. GlideScope Video Laryngoscope from Verathon Medical Canada Celebrates 10th Anniversary of Video Laryngoscopy and Improving Patient Care
10. Verathon Inc. GlideScope Video Laryngoscope Patent Upheld in Court
11. Reportlinker Adds Endoscopy Devices Market to 2016 - Need For Therapeutic Endoscopy and Advancements in HD Endoscopy to Drive Flexible Endoscopes
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/22/2017)... Sept. 22, 2017  As the latest Obamacare repeal ... Bill Cassidy (R-LA) and Lindsey Graham ... the medical device industry is in an odd place. ... the 2.3% excise tax on medical device sales passed ... want covered patients, increased visits and hospital customers with ...
(Date:9/18/2017)... , Sept. 18, 2017  PMD Healthcare of ... Pharmacy of Kalamazoo, Mich. , have ... service that expedites and streamlines patient and provider access ... 2.0, and wellness management services.  ... used to measure lung function for a variety of ...
(Date:9/12/2017)... N.J. , Sept. 12, 2017  Consumer reviews on the ... Hearing as the number one company for hearing aids, ranking ... and fifteen other brands. ... Embrace Hearing Named #1 by Consumers For Hearing Aids ... Embrace Hearing is an online store that provides high ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... Ellevate Network, the leading network for professional ... action towards gender equality at their inaugural Summit in New York City in June. ... a social audience of over 3 million. To watch the Mobilize Women video, ...
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... ... will be giving viewers the lowdown on sciatica in a new episode of ... that focuses on current events and innovation and investigates each subject in-depth with ...
(Date:10/13/2017)... , ... October 13, 2017 , ... “America On The ... identity. “America On The Brink” is the creation of published author, William Nowers. ... great-grandchildren. As a WWII veteran, he spent thirty years in the Navy. ...
(Date:10/12/2017)... New Orleans, LA (PRWEB) , ... October 12, 2017 , ... ... fitness centers in the U.S., announced today its plans to open a flagship location ... club will occupy the former Rooms To Go store next to Office Depot in ...
(Date:10/12/2017)... ... 12, 2017 , ... The American College of Medical Informatics (ACMI) will present ... the Opening Session of AMIA’s Annual Symposium in Washington, D.C. AMIA’s Annual Symposium ... Collen, a pioneer in the field of medical informatics, this prestigious award is presented ...
Breaking Medicine News(10 mins):