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
SEARCH
Current Location:
>
> This Story

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

 

 

Business Affairs Homepage

Forces driving healthcare M&A activity Understanding why consolidation is going to continue

Boston Scientific to buy VENITI for $160 million Price may rise pending FDA approval of Vici Venous Stent

Sotera Health's Nordion closes sale of medical isotopes business to BWX Technologies About 150 employees will be transferred in the deal

FDA clears Aidoc AI solution for triaging head CT scans Flags acute intracranial hemorrhage cases by focusing on abnormal regions

Henry Ford Health System and GM enter "Direct to Employer" healthcare contract A first-of-its-kind arrangement for both organizations

Varian to acquire humediQ Global Bringing IDENTIFY automated workflow solution to surface-guided radiation therapy

Brian Tyler McKesson appoints president and chief operating officer

Researchers offer guidance for weighing value in radiology Cost-effective imaging sounds good, but what IS it?

Understanding the cost impact of healthcare consolidation What distinguishes a 'good' merger from a 'bad' one?

Siemens Healthineers to adjust supply networks to minimize tariff hits Expecting 'low single digit million euro impact' on 2018 finances

Does MITA's service standard sidestep the elephant in the room?

An editorial by Robert J. Kerwin
IAMERS General Counsel

The Medical Imaging Technology Alliance (“MITA”), a division of the National Electrical Manufacturers Association, has circulated for formal balloting and public comment its proposed national standard for servicing of diagnostic imaging equipment.

This follows MITA’s advocacy on Capitol Hill and before the FDA for regulation of independent servicers.

If approved as a standard by the American National Standards Institute (“ANSI”) or by the FDA, the MITA servicing standard would serve to establish the minimum elements of a quality management system for all service providers of medical imaging equipment.

Story Continues Below Advertisement

RaySafe helps you avoid unnecessary radiation

RaySafe solutions are designed to minimize the need for user interaction, bringing unprecedented simplicity & usability to the X-ray room. We're committed to establishing a radiation safety culture wherever technicians & medical staff encounter radiation.



While IAMERS is a strong proponent of quality management systems and indeed conditions membership on adherence to IAMERS’ Best Practices, the MITA standard is troubling and largely unachievable for independent servicers who are routinely denied access by manufacturers to manuals, service keys and training. It's our belief that it is all well and good to establish standards for training, calibration and testing, but the common issue of a manufacturer’s "withholding of important equipment information" necessary to implement these standards continues to be the "elephant in the room" that is being sidestepped.

Independent servicers should email their concerns about this standard to MITA during the MITA comment period (December 8 deadline) not simply because the standard contains a bevy of unachievable or ambiguous provisions, but because it quite deliberately sidesteps obligations of the manufacturer to provide equipment manuals, passwords or service keys.

MITA has advised of its intention to share the standard publicly, but as of this writing it does not seem to be available through access to the MITA website.

The International Association of Medical Equipment Remarketers and Servicers (IAMERS), which I represent, has raised concerns with MITA about the withholding of passwords, equipment manuals and service keys, and was variously informed that MITA does not seek to regulate the behavior of its members on this issue, and that manufacturer obligations do not belong in a servicing standard.

MITA’s explanations seem like sidesteps especially when one considers that MITA informed Congress earlier in the year, and the FDA last year, that its objective in seeking servicer regulation is to ensure all service providers provide the same level of quality and safety. Despite the reports of ECRI and other respected commentators that there is no data in FDA Maude reports of systemic issues, MITA submitted photos of ostensibly unsafe workmanship of nameless independent servicers to make its case for the need to improve patient safety.
  Pages: 1 - 2 - 3 - 4 >>

Business Affairs Homepage


(4)

Richard Geertson

The elephant

November 02, 2017 04:39

Robert,
Well written. It certainly seems that MITA is being purposely vague in an effort to tie the hands of ISOs, or at least make them vulnerable.
And WHO does this benefit? Certainly not the end-user or patients.

Log inor Register

to rate and post a comment

(26)
(4)
(4)

William Dixon

MITA

November 03, 2017 04:01

Robert...Go get em! Clear and concise....but somehow THEY won't be able to understand this even with as matter of Fact ..pointed...supported...and defined as you have stated this quest. There are bigger issues, but as with all bait and switch issues, they want everyones attention over here on this nonexistent matter while we ignore the real "elephant"!

Log inor Register

to rate and post a comment

(11)

(1)

Wayne Webster

Elephants never forget

November 06, 2017 05:15

There's an old idiom, "Don't bite the hand that feeds you." Every schoolboy knows the meaning. So, why don't the OEM's understand what they are proposing with this standard and the restrictions they place on the information required to meet the standard? What will they do when acquiring system wide asset management contracts? How will they service those devices not of their own? What will they do when they earn the wrath of buyers once buyers realize they can't repair or hire whom they wish to repair their device? MITA is a mouthpiece. Where's the intelligence behind it? Here's another idiom the OEM's might consider, "The best-laid plans of mice and men often go awry."

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 ©2001-2018 DOTmed.com, Inc.
ALL RIGHTS RESERVED