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

You have requested to receive a Daily Digest e-mail from U.S. Food & Drug Administration (FDA).

Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 22 Jul 2008 11:02:40 -0500 (CDT)
Subject: Medicines in My Home Update

You are subscribed to Medicines in My Home for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.

“Checklist for Choosing Over-the-Counter (OTC) Medicine for Children.” Before you go to the store to choose an over-the-counter medicine for your child, use this checklist to help you gather the information you need.  At the store, the checklist will help you pick the right medicine. 

 

http://www.fda.gov/cder/medsinmyhome/MIMH_checklist_children.pdf

 

 

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GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420

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

You have requested to receive a Daily Digest e-mail from U.S. Food & Drug Administration (FDA).

Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 8 Jul 2008 08:24:30 -0500 (CDT)
Subject: Drug Information Update- Authorized Generics

The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA. 

On September 27, 2007, the President signed into law the Food and Drug Administration Amendments Act (FDAAA) (Public Law 110-85).  Among other things, FDAAA added new subsection (t) to section 505 of the Federal Food, Drug, and Cosmetic Act (the Act).   Section 505(t) is titled “Database For Authorized Generic Drugs,” and requires that FDA publish a complete list on its Internet site of all authorized generic drugs, including (1) the drug trade name, (2) the brand company manufacturer, and (3) the date the authorized generic drug entered the market.  The agency is required to update the list quarterly.  Section 505(t)(2) of the Act requires the list to contain authorized generic drugs included in an annual report submitted to the agency after January 1, 1999.

An “authorized generic drug” is a listed drug as defined in § 314.3 that has been approved under subsection 505(c) of the act and is marketed, sold, or distributed directly or indirectly to retail class of trade with either labeling, packaging (other than repackaging as the listed drug in blister packs, unit doses, or similar packaging for use in institutions), product code, labeler code, trade name, or trade mark that differs from that of the listed drug.

 

For FDA listing of authorized generics, please visit: http://www.fda.gov/cder/ogd/AG_Listing.htm

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Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 8 Jul 2008 10:04:22 -0500 (CDT)
Subject: Drug Information Update- Fluoroquinolone Antimicrobial Drugs

The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA. 

FDA is notifying the makers of fluoroquinolone antimicrobial drugs for systemic use of the need to add a boxed warning to the prescribing information about the increased risk of developing tendinitis and tendon rupture in patients taking fluoroquinolones and to develop a Medication Guide for patients. The addition of a boxed warning and a Medication Guide would strengthen the existing warning information already included in the prescribing information for fluoroquinolone drugs.

Fluoroquinolones are associated with an increased risk of tendinitis and tendon rupture. This risk is further increased in those over age 60, in kidney, heart, and lung transplant recipients, and with use of concomitant steroid therapy. Physicians should advise patients, at the first sign of tendon pain, swelling, or inflammation, to stop taking the fluoroquinolone, to avoid exercise and use of the affected area, and to promptly contact their doctor about changing to a non-fluoroquinolone antimicrobial drug.

Selection of a fluoroquinolone for the treatment or prevention of an infection should be limited to those conditions that are proven or strongly suspected to be caused by bacteria.

For more information, visit: http://www.fda.gov/cder/drug/infopage/fluoroquinolones/default.htm

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GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420

MedSun Update

Medical Product Safety Network

Highlighted articles include:

How Human Factors Lead to Adverse Events
To minimize human factors problems, devices should be designed according to users’ needs, abilities, limitations, and work environments. This includes the design of the device’s user interface...

FDA's Sentinel Initiative
FDA has launched the Sentinel Initiative, with the ultimate goal of creating and implementing the Sentinel System--a national, integrated, electronic system for monitoring medical product safety...

Request for Proposals: Research in Patient Safety
The National Patient Safety Foundation's (NPSF) Research Grants Program seeks to stimulate new, innovative projects directed toward enhancing patient safety in the United States...

Mismatching Medical Devices and Accessories
FDA continues to see reports describing injuries to patients from the use of incompatible device parts. The article entitled, "Mismatching Medical Devices & Accessories," from the Pennsylvania Patient Safety Authority describes device issues with the Gomco circumcision clamp...

Lead-Associated Endocarditis: the Important Role of Methicillin-Resistant Staphylococcus Aureus
Lead-associated endocarditis (LAE) may be the most serious complication of cardiac device implantation since it is associated with a high mortality...

ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines
This revision of the ACC/AHA/HRS Guidelines updates the previous version published in 2002...

Pacemaker and ICD leads: Strategies for Long-Term Management

Pacemaker and defibrillator therapy is on the rise as a result of expanding indications, unfortunately, this trend is associated with an increased number of cardiac device-related complications...

 

Early Communication About an Ongoing Safety Review of Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, and Cimzia)
FDA is investigating the possible association between the use of medicines known as tumor necrosis factor (TNF) blockers and the development of lymphoma and other cancers in children and young adults...

 

Point-of-Care Testing 
This paper provides a broad overview of one segment of laboratory medicine, point-of-care testing (POCT)...

 

You are subscribed to the MedSun Website, part of U.S. Food & Drug Administration (FDA).

The content on the Homepage has been updated to reflect this month's Newsletter items.  This information can be viewed by clicking here. 

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GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420

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

You have requested to receive a Daily Digest e-mail from U.S. Food & Drug Administration (FDA).

Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 25 Jun 2008 07:48:04 -0500 (CDT)
Subject: Oncology Drugs Update: Velcade (bortezomib) is Approved for Initial Treatment of Patients with Multiple Myeloma

Velcade (bortezomib) is approved for initial treatment of patients with multiple myeloma.
More information: http://www.fda.gov/cder/offices/oodp/whatsnew/bortezomib2008.htm

 

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GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420

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

You have requested to receive a Daily Digest e-mail from U.S. Food & Drug Administration (FDA).

Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 2 Jun 2008 11:04:38 -0500 (CDT)
Subject: The June 2008 MedSun Newsletter is now available...

Medical Product Safety Network

Please note a new audioconference entitled, “The Practice of Laboratory Medicine in the Twenty First Century – Achieving Relevance in a Tidal Wave of Change” has been added to the Educational Materials section.

 

 

Highlighted articles include:

 

Concerns with Heparin

The recent serious injuries and deaths associated with the use of potentially contaminated heparin are of great interest at this time. The following links contain information about the ongoing heparin issue...

 

Large, Single-Center, Single-Operator Experience with Transvenous Lead Extraction: Outcomes and Changing Indications

Examining contemporary indications, outcomes, and complications of transvenous lead extraction in a large series of patients at a high-volume lead extraction center...

 

Complexity of MRI Induced Heating on Metallic Leads: Experimental Measurements of 374 Configurations

Findings highlight the factors that have significant effects on MRI induced heating of implanted wires and lead…

 

Design of the Pacemaker Remote Follow-up Evaluation and Review (PREFER) Trial to Assess the Clinical Value of the Remote Pacemaker Interrogation in the Management of Pacemaker Patients

Although pacemakers are primarily used for the treatment of bradycardia, diagnostic data available in current pacemakers allow them to be also used as sophisticated, continuous monitoring devices...

 

Prevent Pediatric Medication Errors

The Joint Commission’s latest Sentinel Event Alert addresses pediatric medication errors, and urges greater attention to precautions such as medication standardization, improved medication identification and communication techniques...

 

Development, Testing, and Findings of a Pediatric-Focused Trigger Tool to Identify Medication-Related Harm in U.S. Children’s Hospitals

Adverse drug event rates in hospitalized children are substantially higher than previously described...

 

Recognizing the Sources of Interference with Immunoassays

Therapeutic drug monitoring (TDM) has improved patient care but studies suggest that improvements can be made...

 

2008 National Patient Safety Goals Laboratory Services Program

The Joint Commission article lists laboratory program safety goals for 2008...

 

Falsely Elevated Blood Glucose Readings with a Point-of-Care Meter Due to a Maltose-Containing Intravenous Immune Globulin Product

Some glucose meter test strips that use glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) methodology may overestimate measurements when blood maltose levels exceed certain levels...

 

Direct Access Testing (DAT) and the Clinical Laboratory Improvement Amendments (CLIA) Regulations

The objective of the CLIA program is to ensure quality laboratory testing...

     

You are subscribed to the MedSun Website, part of U.S. Food & Drug Administration (FDA).

The content on the Homepage has been updated to reflect this month's Newsletter items.  This information can be viewed by clicking here. 

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GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420

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

You have requested to receive a Daily Digest e-mail from U.S. Food & Drug Administration (FDA).

Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 30 May 2008 11:42:05 -0500 (CDT)
Subject: Drug Information Update- Transition from CFC to HFA Propelled Albuterol Inhalers

The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA. 

FDA is alerting patients, caregivers, and healthcare professionals to important information about albuterol inhalers. As part of a multi-year phase out, chlorofluorocarbon (CFC) propelled albuterol inhalers will not be available after December 31, 2008.  Healthcare professionals should transition patients to the hydrofluoralkane (HFA) propelled albuterol inhalers now. 

There are three HFA propelled albuterol inhalers that have been approved by the FDA: Proair HFA Inhalation Aerosol, Proventil HFA Inhalation Aerosol, and Ventolin HFA Inhalation Aerosol. Also FDA-approved is Xopenex HFA Inhalation Aerosol, an HFA propelled inhaler containing levalbuterol (the active form of albuterol).

HFA propelled albuterol inhalers may taste and feel different than the CFC propelled albuterol inhalers.  Notably, the force of the spray of an HFA propelled inhaler may feel softer than that of a CFC propelled inhaler.  It is important to remember that it is the deep breath that you take with each puff that gets the medication into your lungs, not the force of the spray. It is important to prime and clean the HFA propelled inhalers to prevent blockage in the inhaler device that will prevent the medicine from reaching the lungs.  Each HFA propelled inhaler has different priming, cleaning, and drying instructions.  Therefore, it is important to read and understand the instructions that come with each of the HFA propelled albuterol inhalers before using.

The labeling and instructions for the inhalers may be accessed at: http://dailymed.nlm.nih.gov/dailymed/about.cfm

The national transition from CFC propelled to HFA propelled albuterol inhalers is due to an international environmental treaty called the Montreal Protocol on Substances that Deplete the Ozone Layer.  Under this treaty, the United States has agreed to phase out production and importation of Ozone Depleting Substances (ODS) including CFCs.  Several CFC propelled inhalers containing other medicines have already been phased out.  Over the next several years, other CFC propelled inhalers will be phased out.

If after following the instructions that come with each of the HFA propelled albuterol inhalers you feel the product is not effective or causing you to experience side effects we urge you to report to FDA's MedWatch program. MedWatch is a voluntary system of reporting to FDA any adverse effects and/or product problems. You can find a link to the Internet voluntary reporting form by going to the MedWatch homepage (http://www.fda.gov/medwatch/index.html),   click on "How to Report", then "Reporting by Health Professionals" or "Reporting by Consumers".

You can find more information at http://www.fda.gov/cder/mdi/albuterol.htm

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GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420

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

You have requested to receive a Daily Digest e-mail from U.S. Food & Drug Administration (FDA).

Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 28 May 2008 14:11:38 -0500 (CDT)
Subject: Drug Information Update- FDA Proposes New Rule to Provide Updated Information on the Use of Prescription Drugs and Biological Products during Pregnancy and Breast-feeding

The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA. 

The U.S. Food and Drug Administration today proposed major revisions to the physician labeling for prescription drugs (including biological products) to provide better information about the effects of medicines used during pregnancy and breast-feeding.

The proposed changes to prescription drug labeling would give health care professionals more comprehensive information for making prescribing decisions and for counseling women who are pregnant, breast-feeding, or of child-bearing age about using prescription medications.

Although physician labeling is directed to health care professionals, it is sometimes adapted for use in consumer-directed labeling such as patient package inserts or medication guides when such labeling is approved for a prescription drug.

The proposed rule outlines what important information about the use of medicines during pregnancy and breast-feeding would be required to be added to product labeling for newly approved drugs. Under the proposal, drug labeling would explain, based on available information, the potential benefits and risks for the mother and the fetus, and how these risks may change during the course of pregnancy.

The proposed rule would remove the letter categories from the pregnancy section of prescription drug labeling. The newly designed format, for the pregnancy section of the labeling would have three sections:

• The first section, called the "Fetal Risk Summary," would describe what is known about the effects of the drug on the fetus, and if there is a risk, whether this risk is based on information from animals or humans. The proposal calls for a risk conclusion based on the available data and provides a number of examples depending on the quality and quantity of that data. For example, one risk conclusion might be: "Human data indicate that (name of drug) increases the risk of cardiac abnormalities." This would be followed by a summary of the most important data on the drug’s effects.
• Another section, called "Clinical Considerations," would include information about the effects of the use of the drug if it is taken before a woman knows she is pregnant. This section also would feature discussions about the risks of the disease to the mother and the baby, dosing information, and tell how to address complications.
• The third section, under the heading "Data," would describe in more detail the available data regarding use of the drug in humans and from animal studies that were used to develop the Fetal Risk Summary.

The pregnancy section would also include information about whether there is a pregnancy exposure registry for the drug. Pregnancy exposure registries collect and maintain data on the effects of approved drugs that are prescribed to and used by pregnant women.

The lactation (breastfeeding) section of prescription drug labeling would use the same format as the pregnancy section. The lactation section would provide information about using the drug while breastfeeding, such as the amount of drug in breast milk and potential effects on the breastfed infant.

Certain newly approved drugs would use the new pregnancy and lactation labeling format, while labeling for previously approved drugs will be phased in gradually under FDA’s recent Physician Labeling Rulemaking.

Electronic comments can be submitted within 90 days via the Federal Documents Management System/eRulemaking portal at www.regulations.gov. The FDA will carefully consider the comments in preparing a final rule.

For more information, visit: http://www.fda.gov/cder/regulatory/pregnancy_labeling/default.htm

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GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420

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

You have requested to receive a Daily Digest e-mail from U.S. Food & Drug Administration (FDA).

Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 9 May 2008 09:39:55 -0500 (CDT)
Subject: Drug Information Heparin Update

The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA. 

Please help FDA spread the word about recalls of injectable heparin products and heparin flush solutions that may be contaminated with oversulfated chondroitin sulfate (OSCS).   Affected heparin products have been found in medical care facilities in one state since the recall announcement.  Although product recall instructions were widely distributed, they may not have been fully acted upon at all sites where heparin is used.  There have been many reports of deaths associated with allergic or hypotensive symptoms after heparin administration.  Please see FDA link at http://www.fda.gov/cder/drug/infopage/heparin/adverse_events.htm. 

We ask that health professionals and facilities please review and examine all drug/device storage areas, including emergency kits, dialysis units and automated drug storage cabinets to ensure that all of the recalled heparin products have been removed and are no longer available for patient use.  

 

In addition, FDA would like to inform health professionals about other types of medical devices that contain, or are coated with, heparin.  To read this update, and to learn how to report these problems to FDA, please go to: http://www.fda.gov/cdrh/safety/heparin-healthcare-update.html.  Please report to FDA adverse reactions associated with these devices, as well as any reactions associated with heparin or heparin flush solutions.  

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GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420

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

You have requested to receive a Daily Digest e-mail from U.S. Food & Drug Administration (FDA).

Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 30 Apr 2008 15:39:00 -0500 (CDT)
Subject: The May 2008 MedSun Newsletter is now available...

Medical Product Safety Network

Highlighted articles include:

 

 

Important Notice to Manufacturers and Initial Distributors of Medical Devices That May Contain Heparin Or Are Heparin-Coated

MedSun reporters and other healthcare facilities can still submit heparin reports to MedSun or MedWatch, and they will be directed to the attention of FDA’s Center for Drug Evaluation and Research (CDER)…

 

FDA Makes Recommendations on Medical Devices That Treat Blocked Heart Arteries

Draft guidelines have been issued by FDA to aid the development, testing and manufacture of coronary drug-eluting stents, and devices used to treat blocked heart arteries…

 

Preventing Accidents and Injuries in the MRI Suite

This article provides risk reduction strategies and Joint Commission recommendations to reduce MRI accidents, injuries, and deaths…

 

Alarm Interventions during Medical Telemetry Monitoring: A Failure Mode & Effects Analysis

Healthcare facilities can use the published results of the failure mode and effects analysis to understand telemetry monitoring alarm response processes and as an aid to develop facility-specific risk reduction strategies…

 

Preventing the Retention of Foreign Objects during Interventional Radiology Procedures

The article provides recommendations and safe practices to help prevent the retention of foreign objects during interventional radiology (IR) procedures.  This includes the use of sponge, sharp and instrument counts in IR to prevent the risk of serious patient harm related to the retention of foreign objects in this setting… 

 

Low Frequency Magnetic Emissions and Resulting Induced Voltages in a Pacemaker by iPod Portable Music Players

Based on the observations of an in-vitro study, researchers concluded that no interference effects occurred in pacemakers exposed to the tested iPod devices…

 

FDA's Office of In Vitro Diagnostics Has Approved the Following New Devices for Marketing:
Dako TOP2A FISH pharmDx™ Kit is a laboratory test used to help a doctor assess the likely clinical course for certain patients with breast cancer. The test uses fluorescent DNA probes to measure the number of copies of the TOP2A (Topoisomerase 2 alpha) gene on chromosome 17 in breast cancer cells...

 

You are subscribed to the MedSun Website, part of U.S. Food & Drug Administration (FDA).

The content on the Homepage has been updated to reflect this month's Newsletter items.  This information can be viewed by clicking here. 

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GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420

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

You have requested to receive a Daily Digest e-mail from U.S. Food & Drug Administration (FDA).

Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 16 Apr 2008 13:51:02 -0500 (CDT)
Subject: Drug Information Update- Review of Therapeutic Equivalence Generic Bupropion XL 300 mg and Wellbutrin XL 300 mg

The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA. 

The U.S. Food and Drug Administration received reports of loss of antidepressant effect and new or worsening side effects in some patients who switched from the brand name drug, Wellbutrin XL, used to treat depression, to a generic version of the drug. The FDA reviewed the safety and effectiveness of a generic version, bupropion hydrochloride extended release 300 milligram tablets, manufactured by Impax Laboratories and distributed by Teva Pharmaceuticals. The agency evaluated adverse event reports and other data in order to provide the public with current drug safety information.

 

The FDA has completed its evaluation of Teva’s version of generic bupropion extended- release tablets, marketed as Budeprion XL 300 milligram. The FDA considers Teva’s generic drug to be a safe and effective choice for consumers in treating depression, as it has been shown to meet all requirements for approval, including bioequivalence to the branded drug, Wellbutrin XL 300 milligram. The FDA’s conclusions can be found in a review of therapeutic equivalence that was released today.   

 

Wellbutrin XL is owned by GlaxoSmithKline, Philadelphia, and manufactured by Biovail, Mississauga, Ontario, Canada.

 

Budeprion XL is manufactured by Impax Laboratories, Hayward, Calif., and distributed by Teva Pharmaceuticals, North Wales, Penn.

 

For more information, please visit:

 

Review of Therapeutic Equivalence: Generic Bupropion XL 300 mg and Wellbutrin XL 300 mg

www.fda.gov/cder/drug/infopage/bupropion/TE_review.htm

 

Consumer Education: Generic Drugs

www.fda.gov/cder/consumerinfo/generic_text.htm

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GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420

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

You have requested to receive a Daily Digest e-mail from U.S. Food & Drug Administration (FDA).

Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 31 Mar 2008 13:28:01 -0500 (CDT)
Subject: The April 2008 MedSun Newsletter is now available...

Medical Product Safety Network

Highlighted articles include:

 

Epidural Conduction Device Fractures and Complications of Retained Fragments

The article gives tips to nurse anesthetists on how to prevent potential problems through good practices and encourages the practice of recording catheter retention in medical records and informing patients of retained devices...

 

FDA Requests Comments on Dissemination of Information on Unapproved Uses of Medical Products

The U.S. Food and Drug Administration (FDA) issued draft guidance on "Good Reprint Practices" for industry use in the distribution of medical or scientific journal articles and reference publications that involve unapproved uses of FDA-approved drugs and medical devices...

 

FDA Approves Drug-Eluting Stent for Clogged Heart Arteries

FDA has approved the Endeavor Zotarolimus-Eluting Coronary Stent for use in treating patients with narrowed coronary arteries, the blood vessels supplying the heart...

 

Managing Medical Device Recalls

Provides tips to healthcare facilities on what to do when a medical device recall has been initiated...

 

Surveyed hospitals: Only 10-30 Percent Use Successful CA-UTI Prevention Practices

A recent national survey of urinary tract prevention infection practices revealed that more than 50 percent of hospitals did not have a monitoring system for patients with indwelling catheters and greater than 70 percent did not monitor the duration the catheter was in place...

 

Testing the Technology Acceptance Model for Evaluating Healthcare Professionals Intention to Use an Adverse Event Reporting System

The results indicated that perceived usefulness, perceived ease of use, subjective norm, and trust had a significant effect on a professional's intention to use an adverse event reporting system...

 

Prevent Life-Threatening Communication Breakdowns

A patient died after uneventful elective surgery because his implantable cardioverter defibrillator (ICD) was not turned back on after the procedure...

 

FDA Reminds Healthcare Professionals About Falsely Elevated Glucose Levels

FDA is reminding healthcare professionals of the potential for life-threatening falsely elevated glucose readings in patients who have received parenteral products containing maltose or galactose, or oral xylose and are subsequently tested using glucose dehydrogenase pyrroloquinolinequinone based glucose monitoring systems...

 

 

You are subscribed to the MedSun Website, part of U.S. Food & Drug Administration (FDA).

The content on the Homepage has been updated to reflect this month's Newsletter items.  This information can be viewed by clicking here. 

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