Save the Date - Our next Clean Sweep Live Auction will be on Tuesday, September 26th at 9:30AM EST

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

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


More Magazine Features

Radiation therapy gets more targeted and personalized An overview of new software and equipment innovations

What factors impact the success of a proton therapy facility? Treatment is gaining ground all over the world, but not every new facility is a success

Rethinking CT in the value-based era How premium systems may save your facility money

Get your bearings in a rapidly changing X-ray tube industry A market segment that has recently seen a number of shake-ups

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

See All Magazine Features  

Parts And Service Homepage

Medical Device Cybersecurity Act of 2017: benefits and burdens Does proposed legislation overlook the needs of third-party servicers?

What do unconventional service models tell us about the bone densitometry market? Checking in with the partnership between Alpha Source and GE

Philips and GWU study reveals need for improvement in EDs worldwide Influenced by poor decisions on where to seek medical care

Bayer to sell Multi-Vendor Service business Will increase focus on contrast agents and image acquisition devices

The parts and services big three: What every health care system should be asking Questions that will help mitigate issues down the road

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

Third-party medical equipment service: high stakes in the ongoing debate

By James Laskaris, MD Buyline analyst
From the August 2017 issue of DOTmed HealthCare Business News magazine

Depending on how you cut the pie, servicing and repair of medical equipment in the U.S. is worth more than $14 billion a year.

One ongoing debate is focused on who has the right to service medical technology. Currently, the FDA, the Association for the Advancement of Medical Instrumentation (AAMI) and multiple manufacturers and third-party service organizations, as well as in-house hospital clinical engineering departments, are all actively involved in the discussion of revenue, costs and the effect on patient safety resulting from who services the technology. Even with $14 billion at stake, there is no clear-cut answer.

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.

Years ago, a similar hot topic on the safety of refurbishing single-use medical devices and capital equipment was on the table. This process promised savings of 50 percent or more off the original cost of the device. But OEMs questioned the safety aspects of reprocessed or remanufactured medical devices. The result of this debate was that vendors who refurbished or remanufactured this equipment had to go through the same certification as the OEM.

OEMs have questioned the safety of third-party repair by ISOs and their routine servicing of medical technology. Meanwhile, ISOs and their representative organizations have vehemently cried foul, citing unnecessary regulation and cost increases.

The OEMs and their Medical Imaging Technology Alliance (MITA) have supported passage of the Medical Device Servicing, Safety and Accountability Act, which calls for further regulation of ISOs.

In October 2016, the FDA opened a docket on servicing, and both The Joint Commission and Pennsylvania State University commented that they could find no statistically significant level of safety problems resulting from the activities of any maintenance/service provider.

“This legislation is, however, a solution for a problem which has not been shown to exist,” says the International Association of Medical Equipment Remarketers & Servicers (IAMERS).

IAMERS claims the proposed law would simply add regulation and increase prices.

Supporting the position that third-party service is not associated with patient safety problems is a review conducted of the FDA MAUDE (Manufacturer and User Facility Device Experience) database, which found no evidence that a hazard exists.

However, advocates for greater oversight of third-party equipment stakeholders argue that the MAUDE report research was based on limited data and therefore may not paint a complete picture of the issue.
  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 DOTmed.com, Inc. Copyright ©2001-2017 DOTmed.com, Inc.