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

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



Parts And Service Homepage

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

Costs, revenue, risks: The evolving service market Service has become a key target for lowering equipment costs

In Korea and Italy, imaging OEMs face accusations of anti-competitive actions Are unfair tactics being used to hurt non-OEM equipment servicers?

Richardson Healthcare obtains ISO 13485:2016 certification Strengthens its status as a CT and power grid tube manufacturer

New brands, proven experts lead a new era in the CT tube market The CT market has changed a lot over the last couple years

Q&A with Dennis Durmis, senior vice president, Head of Americas Region, Bayer Radiology Why basic third-party regulations are not about business - but patient safety

Is a CT tube crisis on the horizon? As more scanners enter the market, will tubes be sufficiently available?

Image resolution three times higher with new MR coil Used in preclinical testing for whole-body imaging

Meeting third-party stakeholders halfway: Service after the FDA report A talk with Scot Mackeil and Rob Kerwin

The future of equipment upgrades Satrajit Misra, vice president of Marketing and Strategic Development, Canon Medical Systems Inc., on what lengthening replacement cycles mean for providers

Let’s stop the dangerous waiting game

From the August 2018 issue of DOTmed HealthCare Business News magazine
An editorial by Patrick Hope

The U.S. Food and Drug Administration’s (FDA) conclusion last month that unregistered and unknown third-parties who service medical imaging and other devices require no additional regulation was not the news that manufacturers expected to hear. While we agree with many FDA findings, we reach a far different conclusion on this one. When the original equipment manufacturer (OEM) services an imaging device, there are regulations imposed in the interest of patient safety: Why should others who service medical devices be treated differently and held to a lower standard? Are not patients the primary focus here?

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.

We already know that third-parties are not required to report adverse events observed in the course of servicing medical imaging and other devices. The FDA report found, in part, that there is not enough evidence to conclude that third-party servicing poses a widespread public health concern, but that’s because there is no evidence collected. It is reasonable to surmise that the evidence that is available is the information provided by the OEMs that they are required by law to report. Clearly, the available evidence is incomplete.

How incomplete? The FDA report informed us how little they actually know about medical imaging and other device servicing in the U.S. In fact, we learned from the FDA report that the number of firms performing medical device service in the U.S. is between 16,520 and 20,830. Most of these are non-OEMs and therefore, unregulated, unregistered, and with no requirement to report adverse events. So how much do we really know when only a minority are reporting?

With patient safety driving all aspects of healthcare these days, it seems beyond odd that regulators are not interested in straightforward provisions that would enhance quality and safety for all Americans who need diagnostic imaging.

Each year, millions in this country depend on imaging devices to identify and guide treatment of serious medical issues. Physicians count on imaging technology to aid in precise identification of problems. But these devices – like CT scanners and MR machines – also have the potential to cause physical harm if they are improperly maintained or operated. Beyond that, subpar image quality resulting from poor maintenance could lead to a missed or mistaken diagnosis.

Government policy regarding the standards that govern the servicing and maintenance of medical imaging equipment does not put all parties on an equal playing field. Unlike OEMs, which have to follow strict registration and quality reporting guidelines when servicing their own devices, the 20,000 or so third-party servicing firms in the U.S. are operating in a regulatory void.
  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.