Reviewer ’s report  
 
Title: Exposure of hospitalised pregnant women to plasticizers contained in medical devices  
 
Version: 0 Date: 14 Nov 2016  
 
Reviewer: Andrea Hinwood  
 
Reviewer's report:  
 
General Comments:  
 
This manuscript outlines the results of measurin g plasticizers in medical devices and estimating 
pregnant women's exposure via analysis of the procedures undertaken and devices used in the 
hospital setting. Three categories of pregnant women were assessed and estimates of exposure 
based on the analytica l detection of plasticizers in the devices.   
 
 
 
The manuscript is generally well and written and provides some valuable information on the 
types and nature of plasticizers in common use and to which pregnant women may be exposed.  
Specific comments are made where there may be a lack of clarity or suggestions for improved 
clarity are outlined below.  
 
 
 
The study is separated into two parts an 'analytical study' and 'longitudinal study'. The study 
includes measurement of plasticizers in devices and then an estimat e of pregnant womens 
exposure based on use.  It is suggested these categories of studies are removed as in the context 
of this study - it is not longitudinal even if the participants are part of a longitudinal study. This is 
not clear and maybe something t he authors could address.  
 
 
 
 
Abstract p2  
 
As noted it is unclear why the authors have separated the so - called 'analytical study' and 
'longitudinal study'. It would be clearer to just indicate that the authors measured plastizers in 
medical products then estimated the MD use based on hospitalizat ion. I would remove reference 
to these two components of the study from the abstract.  
 
 
In the abstract need to include the number of women in each treatment group. It would be useful 
to provide a brief description of pathology group. Please consider anothe r term to pathology as it 
is not quite right in terms of this manuscript.. Maybe consider treatment or procedures??  
Background p4  
 
Line 61. Remove the word 'everyday' as these compounds are in the environment?  
 
 
Line 62, consider the use of the word 'compoun d' rather than molecule. Molecule also has a 
particular meaning and in this context is not quite right.  
 
 
Line 69. After 'environment. Evidence shows….'  Replace with ' environment and DEHP can be 
released from MDs'  
 
 
Line 70. Add after 'release… 'from MDs'  
 
 
Line 85. Replace the 'and' after PVC with 'nor'.  
 
 
Line 98. Add a reference after MDs  
 
 
Line 102 paragraph - as noted earlier the use of two studies 'analytical' and 'longitudinal' in this 
paper is not helpful, delete these categories.  
 
 
 
 
Methods  
 
Line 117. There is a focus on phthalates and DEHP but no mention of the other plasticizers 
which are mentioned at line 125.  Consider outlining the fact that you looked at whether all these 
plasticizers were listed as being present? If you didn't then would be useful to i ndicate that even 
though these compounds weren't listed, you analysed them because of their potential to leach or 
migrate out of the product?   
 
 
Lines 139 on. It would be useful to show the QAQC data. Given the prevalence of these devices, 
what are blank or  background concentrations like?  It might be useful to make a comment on 
this. With PBDEs for example - this is a big issue for laboratories because they are common in 
analytical equipment.  
 
 
Line 146. It is suggested the term Descriptive longitudinal study  is replaced with - Study 
Population as from my reading this is not a longitudinal study even if the women recruited were 
part of one and that isn't clear.  
Line 161 - instead of methods, this section is Data Collection. It would be helpful to have 
informat ion on how women were recruited into the study, was informed consent given by 
participants? I am assuming not but need this to be explicit. This is sort of outlined at Line 171 
but needs to be clearer.  
 
 
Line 164, place a 'the' after 'by' and 'before' predom inant   
 
 
Line 169, need to define 'pathological' pregnancies or change the term - but still need a definition 
for inclusion in the study.  
 
 
Chemical analysis:  Need to outline how the percentages of each compound were determined in 
each product as these are the results presented in Table 1.  
 
 
Data Analysis: Line 187 on. Was there any account of other exposures of factors that may 
influence exposures such as visits to general medical practitioners etc??  
 
 
 
 
Results  
 
While the authors have spelt out the compound nam es earlier - it might be useful to repeat them 
in the results section when the results start to be outlined line 198.  
 
 
Remove the headings are previously outlined ie Analytical Study and Longitudinal Study.  
 
 
Introduce Table 1 earlier. For example: The result s of the review of medical devices for their 
composition and the results of GCMS analysis for these compounds is presented in Table 1.  
 
 
 Table 1: Were there no plastisizers in catheters??  Or none detected - why is this section blank?   
 
 
Line 198: Isn't TOT M the most commonly detected plasticizer analysed in multi access infusion 
sets as opposed to the main?? ?? Its also not clear - as noted earlier whether these compounds 
were identified from a prior review. Only the question re the presence of phthalates i s outlined - 
but did the authors review the product manufacturers information about other plasticizers - this 
would be useful and the language needs to be clarified in this first presentation of results.  
 
 
Line 212. 'The characteristics at the time of admiss ion…  ' The characteristics of what? The 
study population , their health etc.  
 
 
As noted the definitions of the outcomes of interest and basis for categorization need to be 
included in the methods section so Table 2 is clear.  Maybe refer to Fig 2 as this i s useful.  
 
 
Line 223, a Table of data in the section on exposure to MDs by each group would be informative 
as the Figure is harder to read with this information.  
 
 
 
 
Discussion  
 
Line 303 - need evidence for the statement made about the beginning of pregnancy will be more 
important than later - this will depend on the chemical, the concentration, developmental phase 
etc. Some additional discussion  on this would be useful.  
 
 
Line 34 6.  Need a reference for statement.  
 
 
Line 348. Need a reference for statement.  
 
 
Line 373 - The exposure to these compounds in other settings is important and this limitation 
could be strengthened.   
 
 
Line 377 Replace 'This descriptive study….' with 'This stud y did not…..'  
 
 
 
 
Conclusion  
 
The conclusion needs to be reworded to focus on the main findings. Lines 397 -401 are a 
discussion point and have been made earlier.  
 
 
It is suggested that lines 397 to line 403 be deleted.  Make a comment that further studies are 
needed to confirm migration of these compounds, use in this and other settings, application of 
suitable biomarkers.  Then in the interim, prevention measures such as reduced frequency of 
changes of MDs be investigated. I think this was what was meant but cl arity is required.  
Are the methods appropriate and well described?  
If not, please specify what is required in your comments to the authors.  
 
No 
 
Does the work include the necessary controls?  
If not, please specify which controls are required in your comments to the authors.  
 
Yes 
 
Are the conclusions drawn adequately supported by the data shown?  
If not, please explain in your comments to the auth ors. 
 
Yes 
 
Are you able to assess any statistics in the manuscript or would you recommend an  
additional statistical review?  
If an additional statistical review is recommended, please specify what aspects require further  
assessment in your comments to the edi tors. 
 
I am able to assess the statistics  
 
Quality of written English  
Please indicate the quality of language in the manuscript:  
 
Acceptable  
 
Declaration of competing interests  
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3. Do you hold or are you currently applying for any patents relating to the content of the  
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holds  or has applied for patents relating to the content of the manuscript?  
 
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