Clean Sweep Live Auction on Wed. May 1st. Click to view the full inventory

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
Current Location:
> This Story

Log in or Register to rate this News Story
Forward Printable StoryPrint Comment




More Exclusive Q&A

The benefits of intraoperative MR Q&A with Dr. John Huston Mayo Clinic neuroradiologist discusses what the advanced capabilities mean for patients – as well as providers

Q&A with Scott Warwick, executive director of the National Association for Proton Therapy Find out what to expect at the year's biggest proton therapy industry event

Q&A with Dr. David Asch, executive director of the Penn Medicine Center for Health Care Innovation What can be done to make EHRs a more seamless part of hospital workflow?

Q&A with ESR president, Lorenzo Derchi Discussing the upcoming ECR meeting and bringing harmony to radiology in Europe

Q&A with Paul Schulz, Healthcare Consulting Manager at Eide Bailly What does it take to successfully implement an RTLS/RFID system into a hospital?

See All Exclusive Q&A  

Parts And Service Homepage

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

MITA publishes QMS standard for servicing of imaging devices First standard dedicated to servicing of medical imaging devices

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

Dennis Durmis

Q&A with Dennis Durmis, senior vice president, Head of Americas Region, Bayer Radiology

by Gus Iversen , Editor in Chief
From the August 2018 issue of DOTmed HealthCare Business News magazine

The FDA ignited a debate across the medical equipment landscape when it opened a docket in 2016 aimed at better understanding third-party service. That investigation culminated in May with the publication of the FDA’s findings.

Some imaging stakeholders have praised the FDA’s report and see it as a conclusion to a long debate, while others think the report leaves the industry with more questions than answers, and more work needs to be done.

Story Continues Below Advertisement

Free Marketplace where Lenders Compete Get Pre-Approved for up to $500,000

Get financing today. We say YES more! Easy, Fast, Application. Pick the payment that best works for you. Tax Benefits + Leasing = Huge Savings! NEVER BE OBSOLETE. NO DOWN PAYMENT. FIXED MONTHLY PAYMENT. MRI, CT, Ultrasound, Digital X-ray, Dental Equipment

HealthCare Business News spoke to Dennis Durmis, senior vice president, Head of Americas Region, Bayer Radiology, to find out why he believes legislative action is needed in order to pick up where the FDA left off, ensuring safe medical device service for patients in the U.S.

HCB News: What were the key findings in the FDA's recent report on third party service?
Dennis Durmis: The FDA issued the following summary of their report:

They believe the currently available objective evidence is not sufficient to conclude whether or not there is a widespread public health concern related to servicing, including by third party servicers, of medical devices that would justify imposing additional/different, and in their opinion, burdensome regulatory requirements at this time.

Rather, the objective evidence indicates many OEMs and third-party entities provide high-quality, safe, and effective servicing of medical devices.

A majority of comments, complaints, and adverse event reports alleging that inadequate “servicing” caused or contributed to clinical adverse events and deaths actually pertain to “remanufacturing” and not “servicing.”

The continued availability of third-party entities to service and repair medical devices is critical to the functioning of the U.S. healthcare system.

The report describes four areas where the FDA intends to pursue action:

1. Promote the Adoption of Quality Management Principles;
2. Clarify the Difference between Servicing and Remanufacturing;
3. Strengthen Cybersecurity Practices Associated with Servicing of Medical Devices; and
4. Foster Evidence Development to Assess the Quality, Safety and Effectiveness of Medical Device Servicing.

HCB News: On June 15, there was a meeting on Capitol Hill to discuss the impact of third-party service and the implications for patient care. Can you tell us about that meeting and the viewpoints that were presented?
DD: The Capitol Hill briefing was sponsored by the Advanced Medical Technology Association (AdvaMed) and the Medical Imaging and Technology Alliance (MITA), in conjunction with Rep. Ryan Costello (R-PA) and Rep. Scott Peters (D-CA) and the House MedTech Caucus, and was chaired by Rep. Anna Eshoo (D-CA) and Rep. Erik Paulsen (R-MN). The briefing provided an overview of third party servicing of medical devices, and the implications for patient care. Specific discussion topics included an overview of the issue and a need for congressional action, from the perspective of medical device manufacturers, third-party servicers, and the patient perspective.
  Pages: 1 - 2 - 3 - 4 - ... >>

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 DOTmed.com, Inc. Copyright ©2001-2019 DOTmed.com, Inc.