Archive for January, 2006

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New Medical Products: First Donor Screening Test for West Nile Virus

Closed Published by Food and Drug Adminstration (FDA): Patient Safety January 31st, 2006 in Patient Safety, Regulatory Affairs

FDA recently approved the first test to screen blood donors for the West Nile virus. The test, called the Procleix WNV Assay, can also be used to screen donors of organs, cells and tissues. The test was developed by Gen-Probe Inc., and will be marke…

Recalls and Safety Alerts: Preventing Hemolysis with Meridian Hemodialysis Blood Tubing

Closed Published by Food and Drug Adminstration (FDA): Patient Safety January 31st, 2006 in Patient Safety, Regulatory Affairs

Baxter Healthcare has alerted dialysis clinics about cases of hemolysis occurring in patients being treated with the company's Meridian Hemodialysis Instrument. The hemolysis was caused by kinking in the blood tubing sets used with the Meridian unit…

Recalls and Safety Alerts: Bacterial Contamination of Vapotherm Devices

Closed Published by Food and Drug Adminstration (FDA): Patient Safety January 31st, 2006 in Patient Safety, Regulatory Affairs

FDA issued updated information about an association between the Vapotherm 2000i device and the occurrence of positive Ralstonia cultures. Ralstonia are gram-negative bacteria that were formerly included in the genus Pseudomonas or Burkholderia. The…

Recalls and Safety Alerts: Avoiding Glucose Monitoring Errors in Patients Receiving Other Sugars

Closed Published by Food and Drug Adminstration (FDA): Patient Safety January 31st, 2006 in Patient Safety, Regulatory Affairs

FDA issued a reminder about the potential for falsely elevated glucose readings in patients who are also receiving products that contain other sugars. These products include oral xylose, parenterals that contain maltose or galactose, and peritoneal …

Recalls and Safety Alerts: Recall of Boston Scientific Vena Cava Filters

Closed Published by Food and Drug Adminstration (FDA): Patient Safety January 31st, 2006 in Patient Safety, Regulatory Affairs

Boston Scientific is recalling certain vena cava filter systems. The recalled devices are small cone-shaped filters used to help prevent pulmonary embolism. The filters are implanted in the inferior vena cava to capture blood clots before they're c…

Recalls and Safety Alerts: Alpha-1 Blockers and Cataract Surgery Procedures

Closed Published by Food and Drug Adminstration (FDA): Patient Safety January 31st, 2006 in Patient Safety, Regulatory Affairs

Boehringer Ingelheim notified healthcare professionals that a surgical condition called Intraoperative Floppy Iris Syndrome has been observed during phacoemulsification cataract surgery in some patients taking alpha-1 blockers such as Flomax (tamsulo…

Recalls and Safety Alerts: Amevive Contraindicated in HIV Patients

Closed Published by Food and Drug Adminstration (FDA): Patient Safety January 31st, 2006 in Patient Safety, Regulatory Affairs

Biogen Idec notified healthcare professionals that the drug Amevive (alefacept) which is used to treat severe chronic plaque psoriasis, is contraindicated in patients infected with HIV. Amevive reduces CD4+ T lymphocytes, which might accelerate HIV …

Recalls and Safety Alerts: Reporting Adverse Events for Drugs, Devices, Biologics and Dietary Supplements

Closed Published by Food and Drug Adminstration (FDA): Patient Safety January 31st, 2006 in Patient Safety, Regulatory Affairs

An important FDA program called "MedWatch" allows health care professionals and consumers to report serious problems that they suspect are associated with the medical products they prescribe, dispense, or use. These reports, along with follow-up inve…

Preventing Medical Errors: Drug Name Confusion: Salagen and Selegiline

Closed Published by Food and Drug Adminstration (FDA): Patient Safety January 31st, 2006 in Patient Safety, Regulatory Affairs

The Institute for Safe Medication Practices recently described several cases where the brand name of one drug was mistaken for the generic name of another. Salagen, a brand name for pilocarpine, is used to treat the dry mouth symptoms caused by Sjog…

New Medical Products: First Donor Screening Test for West Nile Virus

Closed Published by Food and Drug Adminstration (FDA): Patient Safety January 31st, 2006 in Patient Safety, Regulatory Affairs

FDA recently approved the first test to screen blood donors for the West Nile virus. The test, called the Procleix WNV Assay, can also be used to screen donors of organs, cells and tissues. The test was developed by Gen-Probe Inc., and will be marke…

Recalls and Safety Alerts: Preventing Hemolysis with Meridian Hemodialysis Blood Tubing

Closed Published by Food and Drug Adminstration (FDA): Patient Safety January 31st, 2006 in Patient Safety, Regulatory Affairs

Baxter Healthcare has alerted dialysis clinics about cases of hemolysis occurring in patients being treated with the company's Meridian Hemodialysis Instrument. The hemolysis was caused by kinking in the blood tubing sets used with the Meridian unit…

Recalls and Safety Alerts: Bacterial Contamination of Vapotherm Devices

Closed Published by Food and Drug Adminstration (FDA): Patient Safety January 31st, 2006 in Patient Safety, Regulatory Affairs

FDA issued updated information about an association between the Vapotherm 2000i device and the occurrence of positive Ralstonia cultures. Ralstonia are gram-negative bacteria that were formerly included in the genus Pseudomonas or Burkholderia. The…

Recalls and Safety Alerts: Avoiding Glucose Monitoring Errors in Patients Receiving Other Sugars

Closed Published by Food and Drug Adminstration (FDA): Patient Safety January 31st, 2006 in Patient Safety, Regulatory Affairs

FDA issued a reminder about the potential for falsely elevated glucose readings in patients who are also receiving products that contain other sugars. These products include oral xylose, parenterals that contain maltose or galactose, and peritoneal …

Recalls and Safety Alerts: Recall of Boston Scientific Vena Cava Filters

Closed Published by Food and Drug Adminstration (FDA): Patient Safety January 31st, 2006 in Patient Safety, Regulatory Affairs

Boston Scientific is recalling certain vena cava filter systems. The recalled devices are small cone-shaped filters used to help prevent pulmonary embolism. The filters are implanted in the inferior vena cava to capture blood clots before they're c…

Recalls and Safety Alerts: Alpha-1 Blockers and Cataract Surgery Procedures

Closed Published by Food and Drug Adminstration (FDA): Patient Safety January 31st, 2006 in Patient Safety, Regulatory Affairs

Boehringer Ingelheim notified healthcare professionals that a surgical condition called Intraoperative Floppy Iris Syndrome has been observed during phacoemulsification cataract surgery in some patients taking alpha-1 blockers such as Flomax (tamsulo…

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