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


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

 

 

More Magazine Features

The importance of breast MR screening for high-risk patients Experts weigh in on MR's emerging role in breast cancer diagnostics

AI to workflow, breast imaging makes advances A look at the latest innovations reaching the healthcare marketplace

Taking the mystery out of breast density One state at a time, awareness is spreading across the country

The benefits of utilizing teleradiology For some providers, outsourcing image interpretation makes a world of difference

In PET and SPECT, getting more sensitive and working smarter A look at the newest systems on the market

See All Magazine Features  

More Industry Headlines

ECRI to fill guidance void left by shutdown of NGC website Launching interim website with clinical practice guidelines this fall

Israel grants $33 milion to GE, Medtronic, Change Healthcare to boost R&D Bringing high quality jobs and biotech innovation to the country

RCM: The untapped potential for lab valuation Challenges abound in the lab market

Hawaii takes aim at kidney disease with 7T preclinical MR system Will track changes in kidneys to determine disease origins

FDA clears IsoRay's and GT's cesium-131 based brachytherapy Performed during surgery to remove brain tumor, reduces follow-ups

Imaging informatics and the clinical informatics umbrella A discussion with University of Cincinnati's Dr. Alexander Towbin

Digital Surgery launches first real-time AI surgical system for OR New approach may help increase qualified surgeons, global access to care

Why Amazon’s winning the healthcare battle Analyzing the PillPack acquisition and other recent moves by the online retail giant

Philips to oversee strategic revamping of German-based providers Upgrading and replacing equipment in two separate partnerships

MR research raises the question: Is it time to ditch the necktie? Compressing the jugular vein and carotid artery reduces cerebral blood flow

Reprocessing: From FDA regulation to best practices

By Dan Vukelich
From the April 2017 issue of DOTmed HealthCare Business News magazine

The Association of Medical Device Reprocessors (AMDR) turns 20 this year. As the global trade association representing the legal, regulatory and other trade interests of the regulated, commercial “single-use” device (SUD) reprocessing industry, it’s nothing less than extraordinary the changes that have occurred in the reprocessing industry in the last two decades.

Story Continues Below Advertisement

OR Tables, Treatment/GYN/Uro Chairs, Transport Stretchers, Hospital/ICU Bed

iMS combines the superior service of Oakworks Medical and advanced manufacturing technology of FAMED Medical Solutions. The goal of iMS, "Connecting Art and Medical Science" goes way beyond product with exceptional CareLink service. Contact us today!



Reusing single-use devices. It flat-out seems counterintuitive, and yet, what was once shunned is now an FDA regulated industry providing services to a majority of U.S. hospitals, saving hospitals hundreds of millions of dollars a year and reducing medical waste. Safety, savings and sustainability are the cornerstones of the positive financial and environmental impact of reprocessing.

These participating hospitals, including most on the Honor Roll of facilities as listed by U.S. News and World Report, utilize medical device reprocessing to bring economic and environmental benefits to the nation’s health care system, its practitioners and the patients they serve.

How it works: Single-use device (SUD) reprocessing
The growth of SUDs — both in number and in cost — was one factor that led many hospitals to reuse SUDs in the late ‘90s. Greater reliance on SUDs was wasteful, inefficient and expensive. A spent SUD (or one that is opened, but not used) also becomes trash, adding to costs to the environment and a hospital’s waste removal costs. If, technically speaking, the manufacturer or other third party could extend the life of the product to another use, while meeting the same FDA safety standards, why wouldn’t we encourage this? This is where AMDR’s members have stepped up, to provide the FDA with the data demonstrating that they can safely reprocess these products to reduce costs and waste.

Reprocessors turn these former SUDs into new, rebuilt SUDs meeting the same FDA standards for device manufacturing that apply to any other original equipment manufacturer (OEM). The reprocessed devices are, in the FDA’s terms, returned “substantially equivalent” to the predicate OEM device — assuring health care providers and patients that reprocessed SUDs are “as safe and as effective” as a new device. Reprocessors become the manufacturers of these reprocessed SUDs, assuming all manufacturer obligations. This is distinct from the “reprocessing” done in hospitals for reusable devices, whereby OEMs have provided instructions and hospitals implement those cleaning protocols.

Commercial reprocessing is essentially manufacturing, and complies with internationally accepted standards. Devices are collected, disassembled, cleaned, function-tested, repackaged and sterilized. The devices are 100 percent traceable, enabling quality controls and accountability. Reprocessed devices are as safe as the original product they replace, a finding confirmed by the FDA and a 2008 Government Accountability Office (GAO) report.
  Pages: 1 - 2 - 3 >>

Related:


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 ©2001-2018 DOTmed.com, Inc.
ALL RIGHTS RESERVED