I've been getting lots of search engine hits from people looking for info on the recent GE Healthcare consent decree negotiated with the FDA. So here it is.
According to the press release, “The consent decree arises out of several FDA inspections at OEC
facilities in the United States in November 2004 and August, November
and December 2006, in which the FDA investigators made a number of
observations [known as “483's”] relating to non-conformities in GE OEC Medical Systems
Quality System practices and reporting activities.” These problems revolve around surgical imaging products, including OECs
9900 Elite C-Arm System, 9900 Elite NAV C-Arm System, 9800 C-Arm
System, 2800 UroView System, 6800 MiniView System, Insta-Trak 3500 NAV
System, and ENTrak 2500 NAV System. No mention has been made of seized product, but GE has agreed not to resume manufacturing and distribution of
these products in the United States until it meets the following milestones:
- Obtaining FDA approval of GE Healthcares plan to resolve issues
with certain products, specifically, the OEC 9900 Elite C-Arm Systems,
the OEC 9900 Elite NAV C-Arm Systems, and the OEC 9800 C-Arm Systems
currently in use in the U.S. Installed OEC surgical imaging systems
can continue to be used consistent with their intended uses and
labeling, and any recently issued recall notices that apply.
- Having an independent third party auditor undertake a review of GE
OEC Medical Systems Salt Lake City and Lawrence facilities and certify
compliance with FDAs Quality System regulations and reporting requirements.
- Establishing, to FDAs satisfaction, that GE OEC processes, facilities and controls are in compliance with requirements.
A consent decree is a legal agreement between the company and the FDA that
is subject to approval by the federal court. The decree details each
step the vendor must follow before production and shipment of effected products (referred to as “adulterated” by the FDA)
can resume, and prohibits
shipments until the corrections described in the decree are implemented and verified by FDA. A consent decree holds the vendor legally responsible for timely accountability and appropriate action to
correct documented quality shortfalls. The GE consent decree was signed January 12, 2007.
These situations usually start with FDA inspections that find certain Quality System Regulation (QSR) loose ends and/or a number of serious customer complaints. One thing leads to another, and if the loose ends unravel to reveal an overly flaccid regulatory program, the vendor must shut down until things are shipshape again. While this happens occasionally to vendors big and small, and typically does not impact product brand value, vendors do experience a serious loss of revenue that can result in lost market share – not to mention the money spent to rework their QSR systems and product documentation. For the scope of this problem, I would guess that GE is looking at between $1 to $4 million dollars to fix this problem, not counting efforts in the background to ensure other GE divisions are in compliance. This is especially embarrassing for a company like GE who prides themselves in continuous process improvement and even offers Six Sigma consulting to hospital customers.
You can read about the consent decree on the FDA's web site here.