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

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

"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

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 or call 1-413-786-1680 or toll-free 1-800-631-1680. Follow Microtest Laboratories on Twitter @MicrotestLabs at

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

Steve Richter, Ph.D.

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:
(Date:11/29/2015)... Nov. 29, 2015  Strengthening its leadership in connected ... PHIA) today announced IntelliSpace Portal 8.0 , the ... visualization platform that helps radiologists detect, diagnose and follow-up ... Radiological Society of North America Annual Meeting (RSNA) ... 8.0 helps address the changing demands in radiology that ...
(Date:11/29/2015)... -- The GE Health Cloud 1 was unveiled today at ... North America (RSNA) meeting in Chicago ... cloud ecosystem and its applications will connect radiologists and clinicians ... teams – both inside and outside the hospital setting. ... "As the digital industrial leader, we are betting big on ...
(Date:11/27/2015)... November 27, 2015 Une ... photodynamique au Bremachlorin contre le cancer avancé. ... à combiner l,immunothérapie au traitement photodynamique au Bremachlorin ... Une nouvelle approche consistant à combiner ... cancer avancé.    Clinical Cancer ...
Breaking Medicine Technology:
(Date:11/27/2015)... ... November 27, 2015 , ... A team of Swiss doctors ... treat it. Surviving Mesothelioma has just posted the findings on the website. Click ... analyzed the cases of 136 mesothelioma patients who were treated with chemotherapy followed by ...
(Date:11/27/2015)... ... November 27, 2015 , ... Lizzie’s Lice Pickers just announced a ... customers 10% off of their purchase of lice treatment product. In addition, customers will ... to a company spokesperson. “Finding lice is a sure way to ruin the holidays, ...
(Date:11/27/2015)... ANGELES, CA (PRWEB) , ... November 27, 2015 , ... MPWH, the No.1 Herpes-only dating ... of 30 (see Table 1-1 ). More than 3.7 billion people under the ... virus type 1 (HSV-1), according to WHO's first global estimates of HSV-1 infection . ...
(Date:11/27/2015)... ... November 27, 2015 , ... A simply groundbreaking television ... an interesting show that delves into an array of issues that are presently affecting ... benefit from open dialogue, this show is changing the subjects consumers focus on, one ...
(Date:11/27/2015)... ... 2015 , ... CBD College is proud to announce that on ... accreditation to its Diagnostic Medical Sonography program. CBD College is honored to join this ... colleges and universities in the state of California make the cut. CBD College is ...
Breaking Medicine News(10 mins):