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FDA Warns Philips Medical Systems Over Manufacturing Procedures

Apr 23, 2008 | Parker Waichman Alonso LLP

Philips Medical Systems Inc. has been warned by U.S. health regulators about a wide variety of problems with its manufacturing procedures at an Ohio plant.  According to a letter released by the U.S. Food and Drug Administration (FDA), one of the problems cited includes Philips Medical’s failure to oversee proper medical device design.  Philips Medical System is a unit of Philips Electronics NV.

FDA inspectors visited Philips' Cleveland, Ohio plant this past September and October 2007 and found more than one dozen production problems at the facility.  Philips Medical manufactures computed tomography (CT) and nuclear medicine devices.  Among the production problems cited were an inadequate system to manage production changes as well as problems with software to check device and also said Philips Medical Systems did not properly maintain certain investigative records and failed to set up proper procedures to handle complaints.  The FDA cited these issues in an April 1 letter to Philips Medical Systems, which is also quoted as saying, “Your procedure does not require systematic evaluation to determine if an event is ... reportable.”

According to the FDA, Philips Medical has taken some steps to correct the problems since the inspection; however, Philips Medical has yet to address them all.  Philips spokesman, Arent Jan Hesselink, said Philips has resolved 10 out of the 14 FDA complaints.  “On the remaining four, we are still working with them.  It is a matter of implementing some changes, in some cases simply a matter of providing the FDA with documentation,” the spokesman said adding, “We take it very seriously and will do everything we can to make sure that any issues seen by the FDA are solved.”

The FDA issues dozens of warning letters each year and while the majority are resolved without issue, the FDA can impose fines, injunctions, and other civil penalties.

Philips' shares were off 44 cents—over one percent—at $37.87 in late morning trading on the New York Stock Exchange and were down about 1 percent on the Amsterdam exchange.

Meanwhile, in February, researchers from the University of California, San Francisco (UCSF) argued that medical devices are not subject to the same rigorous review process as pharmaceuticals and this needs to change to improve health outcomes and found once a device receives FDA approval, an independent technology review could help identify which devices are beneficial.  According to the team, this data would improve health professionals' awareness of the potential promise and pitfalls of new technology.  Sometimes, the only information on a device is what the manufacturer provides.

The UCSF analysis evaluated the federal review process, how devices come to market, how scientific literature reports on clinical trials involving medical devices, and the effectiveness of independent review boards in improving a technology's medical benefit.   Out of thousands of medical technology applications submitted annually to the FDA, less than 100 undergo the type of scrutiny required for new drugs.  Most new applications are approved through an expedited FDA process that considers new devices similar to those already approved.  Also, the FDA relies on manufacturers and clinical investigators to initiate recalls and failure reports when a technology is not beneficial or is potentially harmful to patients.