Environmental Contaminants Reviews (ECR) 1(2) (2018) 13-21 Cite The Article: Shoaib Ahmed Hab, Farah N. Talpur, Jameel Ahmed Baig, Hassan Imran Afridi, Muhammad Ali Surhio, Marvi Kanwal Talpur (2018). Leaching And Exposure Of Phthalates From Medical Devices; Health Impacts And Regulations. Environmental Contaminants Reviews, 1(2): 13-21. ARTICLE DETAILS Article History: Received 01 January 2019 Accepted 04 February 2019 Available Online 11 February 2019 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. KEYWORDS PAEs leaching, exposure, health implication Medical devices, PAEs alternatives, labeling issues 1. INTRODUCTION Esters of phthalic acids (PAEs) are class of xenobiotic organic compounds which are extensively used for the formation of plastic goods and for making them more flexible. These are not chemically bound to plastics; hence they can easily leach out from it and get mix into surrounding environment [1,2]. Medical devices such as tubing, feeding bags, external nutrition, peritoneal dialysis bags, infusion tubing, oxygen masks, blood bags and catheters are manufactured by polyvinyl chloride (PVC) which contains an average 20–40% DEHP by mass [3,4]. PAEs are used to increase transparency, and durability of plastic materials since 1930s. Each year the production of PAEs is 6 million tons; while in Europe, 1 million tons of PAEs are being manufactured annually [5,6]. Accordingly to low molecular weight, PAEs (low M.W) (ester side-chain lengths, one to four carbons) consist of dimethyl phthalate (DMP), diethyl phthalate (DEP), Dibutyl phthalate (DBP), and Diisobutyl Phthalate (DIBP), dipropyl phthalate (DPrP), and high-molecular-weight PAEs (high M.W.) (ester side-chain lengths, 5 or more carbons) containing di-2-ethylhexyl phthalate (DEHP), di-n- octyl phthalate (DOP), benzylbutyl phthalate (BzBP), and di-isononyl phthalate (DINP) (Figure-1). The most dominant PAEs are DEHP, DiDP and DiNP [7]. The most commonly used PAEs are, DMP, DEP, DBP, DEHP. Figure 1: Structure of commonly used PAEs including DMP, DBP and DEHP Environmental Contaminants Reviews (ECR) DOI : http://doi.org/10.26480/ecr.02.2018.13.21 LEACHING AND EXPOSURE OF PHTHALATES FROM MEDICAL DEVICES; HEALTH IMPACTS AND REGULATIONS Shoaib Ahmed Hab, Farah N. Talpur*, Jameel Ahmed Baig, Hassan Imran Afridi, Muhammad Ali Surhio, Marvi Kanwal Talpur National Center of Excellence in Analytical Chemistry, University of Sindh, Jamshoro, 76080, Pakistan *Corresponding Author Email: farahtalpur@hotmail.com This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. RESEARCH ARTICLE e-ISSN :2637-0778 CODEN: ECRNAE