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
advertisement

 

advertisement

 

Business Affairs Homepage

Clinical wearables – remaining competitive in an evolving market Insights from Ravi Kuppuraj, Business Leader of Connected Sensing Venture for Philips

TIAA Bank acquires $1.5 billion portfolio from GE Capital's HEF business Portfolio of healthcare equipment leases and loans

Daniel Kelsey AHRA hires chief executive officer

Robert Sledd Owens & Minor names board member, chairman and interim president and CEO

Driving premium platform valuations for future growth The radiology M&A market is red hot, help investors see the value in your business

Veritas Capital, Evergreen Coast Capital to take athenahealth for $5.7 billion Gives athenahealth stock holders $135 in cash per share

A look into the medical device design process Go behind the scenes to see what factors contribute to the design of new medical devices

How hassle maps can improve radiology department operations Tips for finding and addressing friction points and improving overall patient care in radiology

When radiologists speak up, follow-up imaging improves Study supports better communication between radiologists and referring clinicians

Dr. Jonathan Luchs Premier Radiology Services appoints chief medical officer

FDA, Philips reach agreement on AED manufacturing over quality control issues

by Thomas Dworetzky , Contributing Reporter
The FDA has reached a deal with Philips North America (also known as Philips Medical Systems and Philips Healthcare) over quality control issues with its automatic defibrillator manufacturing process – announced with a consent decree of permanent injunction entered by U.S. district judge Denise J. Casper.

The October 31 decree, with limited exceptions, “prohibits Philips and those individually named from manufacturing, processing, packing, holding or distributing devices made by the Emergency Care and Resuscitation (ECR) business unit at their Andover, Massachusetts, and Bothell, Washington, facilities until they comply with the Federal Food, Drug and Cosmetic Act (FD&C Act) and FDA regulations, in addition to other requirements,” according to an FDA release.

Story Continues Below Advertisement

RamSoft PowerServer™ RIS/PACS - Enabling Efficient Diagnostic Imaging

RamSoft's PowerServer™ RIS/PACS is an intuitive, single database application that enables healthcare practices to operate diagnostic imaging more efficiently than ever before.Why is this important? Click to find out.



“We are committed to delivering high quality, innovative products and solutions, and we take this matter very seriously,” Chief Business Leader Connected Care & Health Informatics at Royal Philips Carla Kriwet said in a statement when news of the deal was first announced in mid-October.

She emphasized that the company was “fully prepared” to satisfy the decree and hoped to start defibrillator production again in 2018.

“Over the last years, we have made significant investments in our Quality Management System, with the change in our company-wide quality leadership and the launch of new standards and initiatives across all our businesses and markets,” she said, adding that the company would continue “to further enhance our quality management throughout Philips.”

The decree also enjoined two company officers – Kriwet and Ojas Buch, PCMS VP of quality and regulatory assurance, according to the announcement.

“AEDs are lifesaving tools and are designed to be used by the general public or professionals in an emergency,” said Melinda Plaisier, associate commissioner for regulatory affairs at the FDA, advising that “Philips distributed adulterated products that put people at risk.”

The complaint holds that the company was at fault because its AEDs and Q-CPR Meters were made “in violation of current good manufacturing practice (CGMP) requirements under the FD&C Act based on noncompliance with quality system (QS) regulations.”

In addition, Philips didn't set up “ adequate processes” to fix the issues, says the government.

The decree will suspend operations, with few exceptions, in those two locations until the company “completes corrective actions, including hiring a qualified third-party CGMP expert” to make sure it is up to quality requirements – and reports back to the FDA that it is OK to open the facilities again.

In mid-October, when the company had agreed to the terms, Kriwet told HCB News, "Following FDA inspections at the Andover and Bothell facilities from 2009 to 2015, FDA investigators made observations regarding Philips' compliance with the Good Manufacturing Practices and medical device reporting requirements of the Food, Drug and Cosmetic Act, with a focus on how Philips addressed issues of its defibrillators."

To address these concerns the company has put steps in place to restructure its quality control function, she noted, and put in new leadership, retrain personnel and introduce culture change initiatives.

"Philips takes this matter extremely seriously," said Kriwet. "The company is committed to fulfilling the terms of the Consent Decree, and we have already taken actions since 2015 to address this."

Business Affairs Homepage


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