FDA + CPSC news

From the latest Conformity Magazine newsletter:

Save a few bucks and get electrocuted or burn the house down, what a bargain. CPSC Warns Against Counterfeit Electrical Products

“The CPSC says that it has recalled more than one million counterfeit electrical products in recent years, including defective circuit breakers, cell phone batteries, and extension cords. Many of the recalled products were manufactured in China, where they are not tested [for] compliance with relevant safety standards.”

Read the full article for good tips to help spot the counterfeits.

Here’s the most dangerous manufacturing problems I’ve heard of in a long time, FDA Seizes Implantable Medical Devices, Initiates Recall

“In a dramatic action that underscored the severity of the risk to consumers, investigators from the U.S. Food and Drug Administration (FDA) and U.S. Marshals seized all implantable medical devices from a New Jersey-based manufacturer after identifying significant deficiencies in the company’s manufacturing process.”

The FDA press release on the problem with Shelhigh, Inc. medical devices states:

“Physicians should consider using alternative devices. Physicians should also monitor patients with a Shelhigh implant for infections and proper device functioning over the expected lifetime of the device. Patients who think they may have received a Shelhigh device during surgery should contact their physician for more information.”

Also see the official FDA Preliminary Public Health Notification.

Some good advice to anyone using life supporting electrical devices. FDA Cautions User of Implantable Devices About RFIDs

“The U.S. Food and Drug Administration (FDA) is cautioning consumers with pacemakers and other implantable medical devices about the potential for interference from radio frequency identification (RFID) tags.”

The FDA notice makes it clear that there have been no field reports of problems but lab testing has shown potential for problems. They want Doctors to include RFID systems in the list of potential problem sources that they warn their patients about. The current list of potential interference sources includes, portable radio transmitters, cell phones, anti-theft systems, and metal detectors.

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