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

 

Parts And Service Homepage

ISOs and HTMs across the U.S. issue strong opposition to FDA registration proposition Registration mandate for ISOs still a possibility

Senate FDA user fee package excludes ISO registration A reason for ISOs and their customers to be cautiously optimistic about MDUFA IV

Cybersecurity and device integration unlock new opportunities for HTM collaboration Don't get held hostage by ransomware

Congressional hearing on ISO registration: What you missed Spirited discussion and continued uncertainty around the future of third-party service

New legislation would mandate all ISOs register with FDA Get to know the 'Medical Device Servicing Safety and Accountability Act'

Docket Update – What will come of the FDA’s investigation into third-party equipment service? Plenty of opinions regarding the FDA docket

Is XR-29 hurting independent service providers? Emerging certification details may put manufacturers in the driver's seat

Siemens Healthineers partners with VIVO for tech training in India Educating a new generation of medical lab technicians

Behind the scenes at GE’s new U.S. repair headquarters Firmly planted in Wisconsin, GE consolidates repair business under a 280,000 sq. ft. roof

Philips signs 15-year, $65 million strategic partnership with Phoenix Children's Hospital Machine learning will be a major focus

MITA responds to 'unfounded' third-party concerns regarding ISO registration

An editorial by Patrick Hope, executive director of the Medical Imaging & Technology Alliance (MITA)

In an April 27 column in HealthCare Business News entitled “New legislation would mandate all ISOs register with FDA,” Robert Kerwin (representing independent companies that service medical devices) raises concerns about H.R. 2118, the Medical Device Servicing Safety and Accountability Act, bipartisan legislation which would take important steps toward ensuring consistent requirements for servicing of medical devices. Unfortunately, some of his assertions are unfounded.

As Joe Robinson, MITA’s board chairman and vice president, Health Systems Solutions for Philips Healthcare, testified before the House Energy & Commerce Subcommittee on Health, H.R. 2118 contains three provisions. ISOs would need to: (1) register with the FDA, (2) maintain a complaint handling system, and (3) report any adverse events.

Story Continues Below Advertisement

No one knows the Exam Room space the way we do

We've spent the past 50 years focused squarely on improving the exam room itself with better equipment, smarter workflows and more integrated technology. Click to find out how to bring our thinking into your space.



Hospital in-house personnel are explicitly excluded from this legislation. Mr. Robinson said this bill presents a “reasonable and commonsense solution that will protect patients who rely on the safety, effectiveness and reliability of our technologies and not be costly or burdensome to third-party servicers.”

Just to clear the air, this isn’t about whether manufacturers service medical devices better than ISOs. This is about protecting patient safety and ensuring that medical devices effectively do the job they’re supposed to do, plain and simple.

We applaud the fact that many ISOs do a great job and provide high-quality service for their customers. Good quality comes from all corners: manufacturers, ISOs, big businesses, and small businesses alike. Greater visibility into the service marketplace will benefit all of these players.

But as it stands now, the FDA knows almost nothing about third-party servicing of medical devices. Even Dr. Jeff Shuren, FDA’s director for the Center for Devices and Radiological Health, said “there isn’t a great window on exactly what’s happening out there” due to the lack of reporting requirements for third-party servicers.

This legislation seeks to address that concern by requiring third parties to make themselves known to the FDA and implement simple reporting and complaint handling processes. That’s it.

Mr. Kerwin has shared valid concerns that these requirements might overburden his member companies because of registration fees or the need to hire additional staff such as compliance officers. However, the vast majority of medical device manufacturers are small businesses themselves, and they readily adhere to these and far more stringent FDA requirements without issue.
  Pages: 1 - 2 >>

Parts And Service Homepage


(2)

Richard Geertson

H.R. 2118

May 19, 2017 07:34

Does any sentient being actually believe "this isn’t about whether manufacturers service medical devices better than ISOs. This is about protecting patient safety..."

"We applaud the fact that many ISOs do a great job and provide high-quality service for their customers."
Really? Yes, the applause is deafening...
"The point...is not to cast blame or wait for more adverse events to become public before we take action."

And... what adverse events would those be? OH, that's right! You don't know because 'they haven't become public' which is why out of sheer magnanimity, the OEMs have only patient safety in mind by imposing burdensome regulations on the competition...

My cynicism meter is off the charts.

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 ©2001-2017 DOTmed.com, Inc.
ALL RIGHTS RESERVED