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 Mobile Imaging
Current Location:
> This Story

starstarstarstarstar (1)
Log in or Register to rate this News Story
Forward Printable StoryPrint Comment




Parts And Service Homepage

Avante acquires Ultra Solutions Expands inventory and service and repair capabilities

IAMERS panel addresses challenges to European third-party providers Lack of training and awareness are hampering the non-OEM market

Understanding total cost of ownership Making sense of costs less tangible than a sticker price

Comparing the value propositions of multi-vendor and ISO service Similar benefits, but not quite the same

Key considerations and questions to ask when entering the IT / PACS service marketplace Keeping up with an ever-evolving software situation

Beyond service: Life cycle management MD Buyline insights from the recent AAMI meeting

IAMERS endorses FDA commitment to Collaborative Communities, wonders if OEMs will get on board Insights and commentary from IAMERS president, Diana Upton

Beyond silver, gold and platinum: How OEM service is getting more customized Manufacturers aim to give providers everything they want, nothing more

The MITA narrative on third-party equipment service lacks merit: ACCE A response to Patrick Hope's editorial calling for greater regulation

Elevating HTM out of the basement Seven tips to demonstrate the value of your team to the organization

What's happening with the MITA service standard?

An editorial by Robert Kerwin

On January 12, 2018, the Medical Imaging Technology Association (MITA), a division of the National Electrical Manufacturers Association, held a conference call of the canvass group (including independent servicers) and observers.

The purpose of the meeting was to review the results of the first ballot on the proposed MITA American National Standard for Servicing of Medical Imaging Devices. After eight months of standards committee meetings, the MITA canvass group members had failed to approve the standard. All the OEMS had voted to accept the standard. Virtually all the ISOs and the HTM professionals had voted in the negative. The required percentage of canvass group members necessary to approve the proposed standard (67 percent) was not achieved.

Story Continues Below Advertisement


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.

Some sought a more comprehensive quality management system that covered all medical equipment, not just imaging equipment. Some thought that the source document should not be the manufacturer regulation, 21 CFR 820, but rather ISO 9001:2015 or ISO 13485:2016.

IAMERS submitted a comment to the effect that it believed the draft failed to address patient safety responsibilities of the manufacturer to cooperate in providing access to service keys, passwords and training. With the current MITA draft largely based on the quality management system regulation of manufacturers, 21 CFR 820, IAMERS was concerned that it would have the practical effect of excluding some servicers from complying, as the sections pertaining to, among other things, training, testing and equipment maintenance could not be met without addressing manufacturer responsibilities for cooperation.

During the January 2018 call, further input was solicited by MITA as to the reasons for the negative vote and where to go from here. ACCE noted that the current draft limits itself to medical imaging equipment. ACCE advised the call participants that in their view any QMS standard should be applied to servicers of all types of medical equipment. ACCE also restated its concern that the current draft was largely based on a QMS regulation tailored for manufacturers.

One canvass member suggested that MITA might not be the best facilitator for a standard as that member felt there was too much distrust, and suspicion that this could be an effort to protect a revenue stream and not really an initiative to improve safety.

Citing the example of NEMA/MITA XR-29 standard, which was incorporated into P.L. 113-93, I expressed concern that there might be an effort to incorporate the servicing standard into upcoming legislation. MITA advised that this was not their current intent but acknowledged that the MITA draft standard had been provided to certain Congressional staff who had expressed an interest in receiving it.
  Pages: 1 - 2 >>

Parts And Service Homepage

You Must Be Logged In To Post A Comment

Increase Your
Brand Awareness
Auctions + Private Sales
Get The
Best Price
Buy Equipment/Parts
Find The
Lowest Price
Daily News
Read The
Latest News
Browse All
DOTmed Users
Ethics on DOTmed
View Our
Ethics Program
Gold Parts Vendor Program
Receive PH
Gold Service Dealer Program
Receive RFP/PS
Healthcare Providers
See all
HCP Tools
A Job
Parts Hunter +EasyPay
Get Parts
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
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, Inc. Copyright ©2001-2018, Inc.