SEARCH
Current Location:
>
> This Story


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

Never Miss a Story

Sign up for email alerts

 

More Industry Headlines

FDA issues separate MRI recalls to GE and Siemens The unrelated recalls pertain to 132 Siemens MRI systems and 9,369 GE MRI systems

Studies have yet to demonstrate HIEs improve speed, quality, safety and cost: paper Too soon to say hospitals received money’s worth from HIEs, said researchers

Most ER physicians order unnecessary imaging tests: study But will malpractice reform have any effect on that?

House passes SGR repeal with overwhelming majority After a vote of 392 to 37, legislation will go to the Senate

Lung ultrasound beats chest X-ray for pediatric pneumonia: Mounting evidence Can accurate diagnosis be obtained with no radiation at a fraction of the cost?

Physicians aren’t being flooded with new or sick patients under health care reform: report However, it did disrupt payor mix trends

U.K. cancer survival rates 'lag far behind' rest of EU: analysis United Kingdom is far behind other European nations in its battle with cancer, at or near the survival rates in the late 1990s

LIGHT proton therapy system coming to East China First commercial sale of a LIGHT system by manufacturer, Advanced Oncotherapy

Royal Philips and Mount Sinai team up to create a digital image repository for tissue samples May lead to research breakthroughs and better cancer care

Nanotechnology-based medical device market expected to grow $3.5 billion from 2014 to 2019: report Major players face competition from new players

Stryker's Neptune
liquid waste management system.

Stryker recall prompts hospitals to seek alternatives

by Loren Bonner , DOTmed News Online Editor
When the U.S. Food and Drug Administration recalled two models of the Stryker liquid waste management systems last year after two patient deaths and other patient injuries due to providers applying high-flow, high-suction vacuums to passive chest drains using the system, hospitals were faced with the daunting task of looking for alternatives to deal with the unpleasant issue of liquid medical waste.

Liquid medical waste, or Red Bag Waste, is a byproduct of many surgeries and procedures. Most hospitals use an advanced system to handle the sometimes toxic liquid — mainly one of the four Stryker liquid waste management models.

Story Continues Below Advertisement

OiHealthcare - ISO 9001 & 13485 Certified - Call 888-673-5151

Oxford Instruments Healthcare, is a leading ISO 9001 & 13485-certified organization, that specializes in providing quality after-market GE CT and MRI systems, service and parts - at prices you can afford.



The FDA advised hospitals against using Stryker's Neptune 1 Silver and Neptune 2 Ultra liquid waste management systems in October 2012; it also claimed these models were never cleared for marketing. The FDA recommended that health care providers begin using alternative legally marketed devices in their place. Further, hospitals were required to submit a certificate of medical necessity in October and adhere to a list of recommendations if they were not able to discontinue use. Besides submitting the CMN form, these recommendations included implementing a Neptune pre-use checklist, identifying a training facilitator and beginning the transition process for the Silver models. But many experts are advising hospitals to start looking into alternative systems now.

"Regardless of whether you can comply [with the recommendations], it may be that you have to face replacing them," said Chris Lavanchy, engineering director of health devices at ECRI Institute, during an April 17 webinar.

According to Lavanchy, the Silver model has to be replaced by March 2014 because Stryker will not seek 510(k) for that model. Although Stryker will apply for 510(k) for the Ultra model, Lavanchy said there is no guarantee it will be cleared, and this might be problematic because the Ultra is the most common Stryker model used in hospitals, according to ECRI research.

Stryker will no longer be producing the Gold model either, and the Bronze model will only be available in limited numbers.

Based on expert research and opinion, the closed systems are safest for liquid waste management, and point-of-use wall-based systems may offer comparable safety. Lavanchy said that the company Dornoch makes closed systems, although they are priced slightly higher than the Stryker equivalents, and BioDrain and MD Technologies make direct to drain wall-based systems.

Clearly, replacing the Stryker systems is a big issue for hospitals and a costly one too: individual waste management units range in price from $20,000 to $30,000 each, and many hospitals have as many as one per operating room, according to ECRI Institute.

Over 400 people joined the webinar. An ECRI Institute spokesperson told DOTmed News that it was the largest attendance to date for an ECRI Institute webinar.

ECRI Institute's webinar, "Stryker Neptune Waste Management System Recall -- What Now?" is available for viewing in full (for a fee) here.

Related:


Interested in Medical Industry News? Subscribe to DOTmed's weekly news email and always be informed. Click here, it takes just 30 seconds.

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 Center
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 ©2001-2015 DOTmed.com, Inc.
ALL RIGHTS RESERVED