LEACHING AND EXPOSURE OF PHTHALATES FROM MEDICAL DEVICES; HEALTH IMPACTS AND REGULATIONS

Abstract

Phthalates (PAEs) are widely used as plasticizers in medical devices to make polyvinyl chloride flexible and soft. However, PAEs can be leached out from plasticizers undesirably and can migrate within the material and end up with direct exposure to humans. Therefore, a number of studies have been conducted globally focusing on their leaching from medical devices like blood bags, infusion tubing, peritoneal dialysis bags and tubing, catheters etc. In current review an attempt is made to gather information related to leaching, exposure, health implication of PAEs along with the regulation used in different countries. Toxic health effects with the exposure of PAEs includes neurological effects, DNA damage, oxidative stress, asthma with negative impact on lungs, effects on reproductive system, liver impairment and gastrointestinal effects. In addition, leaching studies has shown the presence of DEHP about 31-34 % in peritoneal dialysis set like bags and tubing. DEHP leached out from medical apparatus depends upon temperature, storage time, amount of DEHP present in devices and shaking of device while in touched with medical solution. The exposure of plasticizers for pregnant hospitalised women and infants has also highlighted. In addition, PAEs alternates introduced in market are also discussed like Trioctyltrimellitate/tri-(2-ethylhexyl) trimellitate) along with various regulations regarding the use of PAEs in medical devices and other products. was poor.