U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

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Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 4 Feb 2008 05:50:06 -0600 (CST)
Subject: CDRH New Update

	FDA Home Page | CDRH Home Page | Search | A-Z Index

Date: February 4, 2008

The following new items were added to the CDRH web pages on February 1, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

Guidance for Industry and FDA Staff - Medical Glove Guidance Manual

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Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 4 Feb 2008 11:50:38 -0600 (CST)
Subject: Medtronic Inc. Infusion Pump Recall - Medical Device Safety

Medtronic Inc. has recalled certain models of the SynchroMed EL infusion pumps due to increased rates of the pump motor stalling. When a pump motor stalls, drug delivery will stop suddenly and without warning.

 

You are subscribed to Medical Device Safety for U.S. Food & Drug Administration (FDA).

 

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Message: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 4 Feb 2008 13:04:12 -0600 (CST)
Subject: President's FY 2009 Budget Advances Food and Medical Product Safety, and the Safety of FDA-Regulated Imports

President's FY 2009 Budget Advances Food and Medical Product Safety, and the Safety of FDA-Regulated Imports

The U.S. Food and Drug Administration, part of the U.S. Department of Health and Human Services, is requesting nearly $2.4 billion to protect and promote public health as part of the President's fiscal year (FY) 2009 budget -- a 5.7 percent increase over the budget that the FDA received for the current fiscal year.

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Message: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 4 Feb 2008 13:09:14 -0600 (CST)
Subject: Medical Device Recalls: Medtronic Inc. SynchroMed EL Implantable Infusion Pump

You are subscribed to Medical Device Recalls for U.S. Food & Drug Administration (FDA). Information about the Medtronic Inc SynchroMed EL Implantable Infusion Pump Class I Recall has recently been updated, and is now available.

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Message: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 4 Feb 2008 12:54:37 -0600 (CST)
Subject: FDA MedWatch- FDA MedWatch- Medtronic Inc. SnychroMed EL Implantable Infusion Pump - Class I Recall

FDA issued a Class I Recall of Medtronic Inc, SynchroMed EL Implantable Infusion Pump Models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, and 8627L-18. The device administers drugs to a specific site in the body to treat pain, spasticity (continuous muscle contraction), and cancer. The pump is implanted in the patient, either with or without a side catheter access port, catheters, and catheter accessories. The models were recalled because there is a potential pump motor stall issue that affects SynchroMed EL infusion pumps with motors manufactured before September 1999. If a pump motor stalls, drug delivery will stop suddenly and without warning. This stoppage will result in loss of therapy, return of the patient's symptoms, and/or symptoms of drug under infusion or withdrawal. Healthcare professionals and patients with questions should contact the manufacturer.

Read the complete 2008 MedWatch Safety Summary including a link to the FDA Class I Recall Notice regarding this issue at:

http://www.fda.gov/medwatch/safety/2008/safety08.htm#SynchroMed

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Message: 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 4 Feb 2008 13:40:33 -0600 (CST)
Subject: FDA MedWatch - The February 2008 FDA Patient Safety News Is Now Available...

FDA Patient Safety News (PSN) is a monthly video news show for healthcare professionals. It covers significant safety alerts, recalls, new product approvals, and offers important tips on protecting patients. Read the complete stories and watch or download the video program at http://www.fda.gov/psn. You may have already received notification of some of these safety issues through the MedWatch list serve. However, many of these PSN stories contain video footage and demonstrations that may be especially useful to educators in healthcare facilities and academic institutions.

Stories in the February 2008 edition include:

Helping Patients Avoid Counterfeit Drugs over the Internet (September 2007)
Be sure to use only U.S. sites licensed by a State board of pharmacy…

Safe Use of Pneumatic Tourniquet Cuffs (April 2007)
The effectiveness of the tourniquet cuff can become compromised if the cuff becomes crinkled, folded or bent…

Avoiding Accidental Overdoses when Methadone is Prescribed for Pain (February 2007)
Methadone can build up to toxic levels if it is taken too often, if the amount taken is too high, or if it is taken with certain other medicines or supplements…

Avoiding Burns from Electrodes and Cables during MRI Exams (February 2007)
Radiofrequency fields created during an MRI exam can heat ECG cables and electrodes, seriously burning the underlying skin…

Severe Tissue Injury with IV Promethazine (December 2006)
ISMP warns that administering promethazine parenterally may cause more severe tissue injuries than previously recognized…

For more FDA Patient Safety News, visit http://www.fda.gov/psn . Please send any comments, questions or suggestions about the program to PSNews@fda.gov.

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