DOTmed Home MRI Oncology Ultrasound Molecular Imaging X-Ray Cardiology Health IT Business Affairs
News Home Parts & Service Operating Room CT Women's Health Proton Therapy Endoscopy HTMs Pediatrics
SEARCH
Current Location:
>
> This Story

starstarstarstarstar (3)
Log in or Register to rate this News Story
Forward Printable StoryPrint Comment
advertisement

 

advertisement

 

Parts And Service Homepage

GE sued for allegedly 'freezing-out' ISOs in anesthesia equipment maintenance Lawsuit claims monopolistic practices

Varex Imaging and H+P Advanced Technology to build carbon nanotube company Expect to see products come out in two-to-three years

Varex Imaging expands service offering to Europe, releases new tube and detector line at ECR Provide technical and logistical support for installations

Probo Medical acquires Trisonics Now offers an extensive ultrasound service division

MITA's remanufacturing white paper recalls 'Groundhog Day' movie: IAMERS A call for forward thinking and community awareness

MITA proposes framework for defining 'service' versus 'remanufacturing' Also points to the need for quality management systems to be implemented

Is there life after EOL for medical imaging equipment? Ken Hable of Technical Prospects discusses why the concept of 'end of life' is a falsehood

FDA extends deadline for device servicing docket comments One more month for equipment stakeholders to make their voices heard

Merry X-Ray acquires Conquest Imaging Ultrasound repair leader joins growing imaging ISO

New FDA draft guidance on X-ray equipment addresses access to manuals An update to guidances issued 30 years ago

MITA publishes QMS standard for servicing of imaging devices

by John R. Fischer , Staff Reporter

“The MITA Service standard did not get approval by the HTMs and ISOs," Robert Kerwin, legal counsel for IAMERS, an industry group representing equipment remarketers and servicers, told HCB News. "Stakeholders should recognize that it was not endorsed, as it was based on the FDA QSR regulation pertaining to manufacturers and did not adequately address training and calibration of equipment.”

The NEMA/MITA 2 standard is based on ISO 9001, a general quality system standard which can be adopted by any type of organization; ISO 13485, a quality system standard for the medical device industry; and the FDA Quality System Regulation. According to Hope, it also incorporates input from a wide variety of stakeholders, including medical imaging device manufacturers, independent servicing organizations, clinical engineers, hospital system regulators, and accreditors.
Story Continues Below Advertisement

THE (LEADER) IN MEDICAL IMAGING TECHNOLOGY SINCE 1982. SALES-SERVICE-REPAIR

Special-Pricing Available on Medical Displays, Patient Monitors, Recorders, Printers, Media, Ultrasound Machines, and Cameras.This includes Top Brands such as SONY, BARCO, NDS, NEC, LG, EDAN, EIZO, ELO, FSN, PANASONIC, MITSUBISHI, OLYMPUS, & WIDE.




Though designed primarily for medical imaging device users, the principles and guidelines of the standard can be applied to the servicing of other types of equipment. MITA expects it to serve as a foundation for the development of other standards and to help in its aim to work with stakeholders in the development of an American National Standard for quality management of servicing medical devices.

“MITA has elected to publish this document as a NEMA Standard, given the ongoing need to protect patient safety and device integrity through the adoption of quality management principles in the medical imaging device servicing industry," said Hope and Weems. "All entities that engage in servicing of medical devices should be held to consistent quality, safety, and regulatory requirements, including adoption of appropriate quality management systems such as NEMA/MITA 2, registration with the FDA, and filing of adverse event reports.”

Back to HCB News
<< Pages: 1 - 2

Parts And Service Homepage


(12)

Wayne Moore

MITA Service Standard

March 15, 2019 08:08

Your DOTMED article says that ISO 13485 is only for manufacturers of medical devices; this is simply NOT true. ISO 13485 is designed to be used by all organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes. In short it is designed by ANYONE involved in the above including servicing. Get the facts right before you publish your news releases.

Log inor Register

to rate and post a comment

(3)
(1)

John R. Fischer

re: MITA Service Standard

March 18, 2019 10:31

Hi Wayne,

Thanks for the comment. My article states ISO 13485 is for manufacturers. It does not state it is only for manufacturers. My apologies to anyone who may have been confused - I have revised the article to state "ISO 13485 is a quality system standard for the medical device industry."

Log inor Register

to rate and post a comment

(12)

Wayne Moore

re: re: MITA Service Standard

March 19, 2019 10:26

10-4

Log inor Register

to rate and post a comment

(2)

Stephen Grimes

re: MITA Service Standard

March 28, 2019 09:30

Examine the current 13485 standard and you will it see input was only from OEMs and not from third party servicers. Irrespective of what the what the standard says, it's a dubious claim to make that the standard is appropriate for third party servicers when no 3rd party servicers were involved in its development.

Log inor Register

to rate and post a comment

You Must Be Logged In To Post A Comment

Advertise
Increase Your
Brand Awareness
Auctions + Private Sales
Get The
Best Price
Buy Equipment/Parts
Find The
Lowest Price
Daily News
Read The
Latest News
Directory
Browse All
DOTmed Users
Ethics on DOTmed
View Our
Ethics Program
Gold Parts Vendor Program
Receive PH
Requests
Gold Service Dealer Program
Receive RFP/PS
Requests
Healthcare Providers
See all
HCP Tools
Jobs/Training
Find/Fill
A Job
Parts Hunter +EasyPay
Get Parts
Quotes
Recently Certified
View Recently
Certified Users
Recently Rated
View Recently
Certified Users
Rental Central
Rent Equipment
For Less
Sell Equipment/Parts
Get The
Most Money
Service Technicians Forum
Find Help
And Advice
Simple RFP
Get Equipment
Quotes
Virtual Trade Show
Find Service
For Equipment
Access and use of this site is subject to the terms and conditions of our LEGAL NOTICE & PRIVACY NOTICE
Property of and Proprietary to DOTmed.com, Inc. Copyright ©2001-2019 DOTmed.com, Inc.
ALL RIGHTS RESERVED