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

Nationwide hosts IAMERS forum on QMS in advance of FDA report Stakeholders discuss ISO quality management systems

As in-house capabilities grow, contracts become customizable Parts and service contracts are evolving in-step with the needs of hospitals

OEMs sweeten the service deal with expanded options An update on managed equipment service contracts and the benefit to hospitals

Proactive monitoring of imaging devices has far-reaching benefits Insights from UnityPoint Health on the value of CT and MR certainty

What does ISO certification mean for parts providers and their customers? Q&A with Jeffrey Rindfleisch, Vice president of operations at Technical Prospects

How is XR-29 impacting hospitals and their CT service agreements? Many facilities face choices and there's no single right answer

Equipment service stakeholders to meet with FDA after passage of MDUFA IAMERS, AAMI and FDA to hold meeting on servicing best practices

Connected radiology devices can maximize uptime How the radiology suite is discovering the benefits of internet connectivity

The future of medical device parts and service Chris Nowak, corporate director of Healthcare Technology Management at the UHS of Delaware, on the importance of investing in the right personnel

As Dunlee facility closes, U.S. sales and service will merge with AllParts Call centers will be combined going forward

Senate FDA user fee package excludes ISO registration

By Robert J. Kerwin
IAMERS General Counsel


The FDA Medical Device User Fee Amendments (MDUFA IV) package is heading to a Senate committee vote — and it appears not to include any of the House legislative language on independent servicer registration.

Today’s Senate mark-up of the package was delayed, but is expected shortly. Currently, the Senate amendment includes riders on over-the-counter hearing aids, risk-based device inspections, and several other amendments also considered recently by the House during the hearing on the servicing legislation.

Story Continues Below Advertisement

Streamline Your Radiology Workflow with RamSoft's PowerServer RIS/PACS

The PowerServer RIS/PACS is a single database application, essential to reducing redundant work, limiting manual data entry, and increasing consistency throughout healthcare practices. Click to learn how it will help you improve patient care and more.



Notably absent from the Senate amendments is language which would require independent service organizations (ISOs) to register with the FDA.

When the House and Senate approve measures in their respective chambers, a conference committee is often formed to resolve differences in the two measures. A conference committee will likely occur on the FDA User Fee package as this is a major legislative initiative for both House and Senate.

The House Energy & Commerce Committee has yet to introduce its reauthorization. This week the House is in recess and will return next week. IAMERS members have been contacting their Congressional representatives and members of the House Subcommittee on Health to express their strong opposition to the registration bill, and will welcome continued efforts by ISOs to voice their concern.

Robert J. Kerwin
Without any real-world evidence to support a change, the House registration bill would require ISOs to register with the FDA and adopt complaint handling systems similar to those implemented by original equipment manufacturers (OEMs). Making ISOs report like OEMs does not reduce health care costs or advance competition and many independent servicers see the measure as a red herring.

There are negative implications to the House Registration bill which hopefully will not have to be explored. Among them is the possibility that the language is drafted so broadly that even electricians would need to register with the FDA if they do electrical work for medical devices.

Given the potential change in equilibrium, we are hopeful that the House User Fee Package will exclude ISO registration provisions. In this time of rising health care costs and emphasis on smart regulation, a provision of this type could cause hospitals to face increased costs without an appreciable patient safety benefit.

Back to HCB News
  Pages: 1

Parts And Service Homepage


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