PVC-Containing Devices: FDA Update

Medical Devices Containing DEHP Plasticised PVC; Neonates and Other Groups Possibly at Risk from DEHP Toxicity

The safety of medical devices containing DEHP plasticized PVC or other plasticizers on neonates and other groups possibly at risk (2015 update).

...................................................................................................................... 4 EXECUTIVE SUMMARY ................................................................................................ 5 1. BACKGROUND...................................................................................................... 11 2. TERMS OF REFERENCE .....................

NIEHS/FDA CLARITY-BPA research program update

Bisphenol A (BPA) is a chemical used in the production of numerous consumer products resulting in potential daily human exposure to this chemical. The FDA previously evaluated the body of BPA toxicology data and determined that BPA is safe at current exposure levels. Although consistent with the assessment of some other regulatory agencies around the world, this determination of BPA safety cont...

Migration of Phthalate-based Plasticizers from PVC and non-PVC Containers and Medical Devices

A presença de cinco plastificantes derivados de ftalatos em equipamentos para administração intravenosa de soluções e em hemodialisadores (HD), que são feitos tanto de policloreto de vinila (PVC) quanto de outros materiais poliméricos, foi investigada. Destes ftalatos, o único autorizado por agências reguladoras é o di-(2-etilhexil) ftalato (DEHP) em equipamentos de PVC. A determinação foi feit...

FDA: reuse of single-use devices.

Additional news items in this issue: Eradication ofMRSA From a Health Center Ward and Nursing Home, page 334; Intra-abdominal VRE Infections: The New Threat, page 346; Serratia Outbreak From Contaminated Pressure-Monitoring Equipment, page 356; New Guidelines for Design and Construction of Hospitals, page 362; CDC Issues Infection Control Guidelines for Hemodialysis Centers, page 369; Transmiss...