August 6, 2003 - A new study warns that patients receiving frequent transfusions of blood stored in polyvinyl chloride (PVC) bags, normally supplied by blood banks, are exposed to the risk of developing brain disorders.

Here is an article from PTI News in New Delhi, India.

June 2, 2003 - A panel of child health experts wants more research into the possible harmful effects of plastic softeners called phthalates, including diethylhexyl phthalate (DEHP).

Last year, the U.S. Food and Drug Administration (FDA) encouraged hospitals to minimize the use of devices with DEHP in patients considered most at risk of being harmed by the substance, including young boys undergoing kidney dialysis. Story from HealthScoutNews.com. (link is no longer available)

September 9, 2002 - The Center for Devices and Radiological Health has released a Draft Guidance for Industry and FDA on medical devices made with polyvinylchloride (PVC) using the plasticizer di-(2-Ethylhexyl)phthalate (DEHP).

A new plasticizer, Hexamoll Dinch (di-ester-based cyclohexanedicarboxylic acid), is being introduced by BASF in Europe.

July 16, 2002 - The Food and Drug Administration (FDA) has released a Public Health Notification on PVC Devices Containing the Plasticizer DEHP. Here is the advisory from the FDA's Center for Devices and Radiological Health.

Sick baby boys may be at highest risk from exposure to DEHP, a chemical used to soften such plastic medical devices as blood bags and IV tubes. Hospitals are advised to consider using devices made of different materials to treat these patients. Devices that may contain DEHP-plasticized PVC include:

• intravenous (IV) bags and tubing
  
  
• peritoneal dialysis bags and tubing
  
  
• tubing used during hemodialysis

The following procedures have been identified as among those posing the highest risk of exposure to DEHP:

• hemodialysis in peripubertal males
  
  
• hemodialysis in pregnant or lactating women

January 26, 2002 - A Canadian advisory panel on DEHP in medical devices has recommended that hospitals stop using vinyl medical devices around infants, prepubescent boys, pregnant women and nursing mothers because of the danger of reproductive problems. Story from National Post On-line (no longer available).

September 6, 2001 - U.S. health officials said on Wednesday that a plastic softener, known as DEHP and used in some medical bags and tubes, could be harmful to people, but they have not seen any evidence of ill effects. The report states there is little concern for adults receiving intravenous solutions or undergoing peritoneal dialysis. However, there may be concern for nursing mothers receiving hemodialysis treatments. Here is a summary from Reuters/Yahoo (link no longer active).

The FDA has provided a Consumer Update about DEHP in plastic medical devices.

"Safety Assessment of Di(2-ethylhexyl)phthalate (DEHP) Released from PVC Medical Devices" - 119-page report (pdf format) from the FDA web site.

Here is a press release about the FDA statement from the Health Care Without Harm web site. (link is no longer available)

The Health Care Without Harm site has a 72-page report on DEHP (pdf format). (link is no longer available)

March 8, 2000 - The Vinyl Institute has issued a press release stating that the International Agency for Research on Cancer (IARC) has removed the probable-human-carcinogen rating for di(2-ethylhexyl) phthalate (DEHP), the plasticizer used to soften vinyl medical products. Here is the Vinyl Institute web site.

June 22, 1999 - The FDA has been petitioned to provide warnings about the potential health hazards involved with the use of DEHP, a chemical added to PVC to make it soft and pliable. Dialysis patients are probably exposed to more PVC IV bags than any other medical population.

This effort is being headed up by Health Care Without Harm, which is part of the Institute for Agriculture and Trade Policy, a non-profit organization that addresses environmental issues.

Here is Baxter's latest information about PVC and DEHP.


[This message has been edited by Gary Peterson (edited 08-06-2003).]

Message added to update latest post date.