DEHP in Plastic Medical Devices
• What is DEHP and how is it used?
• Why are there health concerns regarding DEHP?
• Is there evidence that these effects occur in humans?
• If these effects occur in humans, which patients would be at most risk?
• What has been done to date to assess the potential risk?
• What can be done to reduce the level of DEHP exposure?
FDA Public Health Notification
PVC Devices Containing the Plasticizer DEHP (July 12, 2002)
This is to inform you that FDA's Center for Devices and Radiological Health completed its safety assessment of Di(2-ethylhexyl)phthalate (DEHP) released from polyvinyl chloride (PVC) medical devices in September, 2001, and to advise you of steps that you can take to reduce the risk of exposure in certain populations.
PVC & DEHP
The chemical compound DEHP, Di(2-ethylhexyl) phthalate, is contained in many of the common plastic products found in health care settings. It is in a category of toxic chemicals known as pthalates, which are commonly added to polyvinyl chloride (PVC) plastic to make the plastic product flexible and strong. It allows the otherwise stiff PVC to be molded into a variety of products such as IV tubing, IV bags, and feeding tubes. By weight, DEHP comprise 20- 40% of the PVC products on average. There is new evidence regarding the human toxicity associated with exposure to DEHP that should help to inform our product selection in the health care setting.
Y – Needle Guide Wire Introducer Needle
-According to Annex X Section 1.1.1 – of the 93/42/EEC Medical Device Directive. Using compilation of the relevant scientific currently available on the intended purpose of the techniques employ. Y – Needle Guide Wire introducer unique design allows access to the vein without disconnecting the syringe attached to the needle. The Y – needle has a one way integral valve to prevent blood leakage and the risk of embolism during insertion.
Packaging For Terminally Sterilized Medical Device EN868
Crepe Paper - Minimum requirement : 60gsm medical crepe paper
Non woven Wrap - Minimum requirement : 40gsm non woven SMMS/SMMMS wrap
-Minimum requirement : 60gsm medical paper
-Double Folded Paper Bag at bottom sealing side to avoid leaking or opening before & after sterilization.