electronic cigarettes: incorporating human factors engineering into risk assessments

Objective to systematically review the effects of human factors (HF)
About the risks related to electronic cigarettes (e-cigarettes)
And find out the research gap.
HF is an evaluation of human interaction with products, including analysis of user, environment and product complexity.
Consideration of HF may mitigate known and potential hazards in the use and misuse of consumer goods, including electronic productscigarettes.
Methods five databases were retrieved in January 2014 and incorporated into HF-related publications.
Voluntary adverse events (AE)
Report to the US Food and Drug Administration (FDA)
Packaging labels for 12 e-
The cigarette products were analyzed.
Results there was no study specifically on the impact of HF on e-commerce
Risk of cigarette use was found. Most e-
Cigarette users are smokers, but the data of the user group is inconsistent.
No article dedicated to e-commerce
Cigarette use environment, storage conditions, product operation requirements, product complexity, user error or misuse.
12 published studies were analyzed
Cigarette labels and conclude that the label is insufficient or misleading.
FDA labeling analysis reveals similar issues described in the literature.
AE reports related to design issues are increasing and deaths related to accidental exposure and misuse have also occurred;
However, no publication was found to assess the relationship between AEs and HF.
Conclusion HF vs e-
The use of cigarettes and the associated hazards are not sufficiently characterized.
In-depth analysis of the user-product-environment interface requires product complexity and AEs related to typical and atypical use to better combine HF engineering principles, to inform and potentially reduce or mitigate with e-
Cigarette products.
Objective to systematically evaluate the impact of human factors (HF)
About the risks related to electronic cigarettes (e-cigarettes)
And find out the research gap.
HF is an evaluation of human interaction with products, including analysis of user, environment and product complexity.
Consideration of HF may mitigate known and potential hazards in the use and misuse of consumer goods, including electronic productscigarettes.
Methods five databases were retrieved in January 2014 and incorporated into HF-related publications.
Voluntary adverse events (AE)
Report to the US Food and Drug Administration (FDA)
Packaging labels for 12 e-
The cigarette products were analyzed.
Results there was no study specifically on the impact of HF on e-commerce
Risk of cigarette use was found. Most e-
Cigarette users are smokers, but the data of the user group is inconsistent.
No article dedicated to e-commerce
Cigarette use environment, storage conditions, product operation requirements, product complexity, user error or misuse.
12 published studies were analyzed
Cigarette labels and conclude that the label is insufficient or misleading.
FDA labeling analysis reveals similar issues described in the literature.
AE reports related to design issues are increasing and deaths related to accidental exposure and misuse have also occurred;
However, no publication was found to assess the relationship between AEs and HF.
Conclusion HF vs e-
The use of cigarettes and the associated hazards are not sufficiently characterized.
In-depth analysis of the user-product-environment interface requires product complexity and AEs related to typical and atypical use to better combine HF engineering principles, to inform and potentially reduce or mitigate with e-
Cigarette products.
Introduce \"human factors \"(HF)
Analysis refers to the evaluation of how human users interact with the product, and consider the user features, use environment and product complexity.
1 HF is analyzed to inform the implementation of design principles that focus on user-Environment-product interaction, thereby minimizing hazards and risks associated with product use.
Due to engineering (HFE)
The principle is designed to make the product easier or harder (as appropriate)
Use and reduce or mitigate any potential hazards of use of the product, especially those directly related to poor product design.
2 analyze the data in the user profile, product usage research and product failure or fault report to improve the design of current and future products.
HFE takes into account past and present product designs, as well as possible features and behaviors of intentional and unintentional product users, such as children who may have unattended access to the product.
2 HFE occupies a prominent position in determining the cause and remedy of the failure of consumer goods, such as the sudden unexpected acceleration of the car.
3 Electronic Cigarettes (e-cigarettes)are battery-
Equipment that powers a chemical mixture (‘e-liquid’)
It usually contains nicotine, propylene alcohol, spices and other ingredients.
The purpose of this paper is not to compare the risks of e-commerce
Comparison of cigarettes with traditional cigarettes, but review the use
Related risks of e-commerce
And identify strategies to reduce hazards associated with these products.
Publication and voluntary report to the US Food and Drug Administration (FDA)suggest that e-
The use of cigarettes may be at a risk that the public cannot identify.
Risk of exposure to electronic products
Liquid leaking or overflowing
Ignition and explosion of cigarettes and contaminants exposed to electronic devices
Liquid and aerosol are issues of concern to HF.
These risks can be exacerbated by poor product design, user behavior, or both.
Figure 1 illustrates the interaction between HF considerations and their possible results.
Download the new tabDownload figureOpen powerpointFigure1 Human Factor (HF)
Consideration and potential results of e-commercecigarette use (
Adapted from the Food and Drug Administration guidance document related to HF engineering).
2 Electronic Cigarette Use-
Relevant hazards should be identified, understood and resolved by applying HFE to e-commerce
Cigarette design process to minimize consumer risk.
Expand understanding of these issues and identify gaps in knowledge, scientific literature, voluntary adverse events (AEs)
Reports to FDA, media reports and 12 electronic samples
The label of cigarette products was analyzed.
Methods literature retrieval and resource review system literature retrieval of five reference databases (
Web of Knowledge, postgraduate studies, SciFinder, Embase and EBSCOhost)
In January 2014, electronic devices and electronic devices were performed using the most searched keywords \"or\" electronic smoking cessation nicotine delivery system or electronic nicotine delivery system \"or\" electronic cigarettes \"or electronic cigarette \',\'
Cigarette or e-
Cigarettes or \'e \'-cig’ OR ‘e-
Cigs identify research and publications related to e-commercecigarettes.
The title and summary of the identified 455 articles were manually screened for the correlation between HF and user hazards.
The article included is (1)
Written in English; (2)
Accessible and inaccessible
Keep confidential using FDA resources or public information; and (3)
Partial or full processing of HF-related aspects related to e-commercecigarettes.
The effectiveness and intensity of each study is determined based on qualitative assessments of research objectives, design, population sampling strategies, depth of analysis, risk of bias, and interpretation of results.
A total of 31 analytical articles have been produced for the application of these standards;
All articles were published between 2009 and 2014.
We also reviewed the tobacco product Center (CTP)daily news (
News clips from the clip service)
Relevant information.
Analysis of CTP AEs database related to e-
During the period from 2008 to December 31, 2013, the use of cigarettes voluntarily reported to the FDA/CTP was reviewed for its nature, severity, possible HF contributions and impact on product labeling.
AE definition of E-application
Cigarettes are adapted according to the concepts in regulations 4 and Guide 5 for research drugs and non-research drugs
Prescription products.
Electronic label analysis
12 e-cigarette products labeled by FDA/CTPThe
Cigarette products from 9 manufacturers (table 1)
7-12 was analyzed using tools developed by FDA.
The tool is an unweighted list of 65 elements in a broad category, including claims; package design;
Product and manufacturer identification on the outer packaging and main parts;
Content, notability, readability and ease of health precautions;
And instructions for use.
We rated each tag element as \"now\" or \"absent\", including qualitative markers, and reported findings using descriptive statistics.
Samples include products evaluated in published label analysis (n=7)
At the end of 2012, a product considered by one or more independent analysts to be popular (n=8)
And the products that the FDA has received the AE report (n=7).
I sample includes rechargeable starter kit, cartridge and cartomizers, electronics
Liquid for filling ink cartridges and disposable electronic productscigarettes. FDA-
Approved labels for prescription 13 and non-prescription 13
Prescription nicotine replacement product 14 for reference.
All levels of the packaging label were reviewed and the product was measured to assess whether there was a potential choking hazard and to check if the label correctly addressed the risk.
View this table: view an example of a spreadsheet
Cigarette products analyzed by CTP for labeling (n=12)
System literature search for 5 reference databases (
Web of Knowledge, postgraduate studies, SciFinder, Embase and EBSCOhost)
In January 2014, electronic devices and electronic devices were performed using the most searched keywords \"or\" electronic smoking cessation nicotine delivery system or electronic nicotine delivery system \"or\" electronic cigarettes \"or electronic cigarette \',\'
Cigarette or e-
Cigarettes or \'e \'-cig’ OR ‘e-
Cigs identify research and publications related to e-commercecigarettes.
The title and summary of the identified 455 articles were manually screened for the correlation between HF and user hazards.
The article included is (1)
Written in English; (2)
Accessible and inaccessible
Keep confidential using FDA resources or public information; and (3)
Partial or full processing of HF-related aspects related to e-commercecigarettes.
The effectiveness and intensity of each study is determined based on qualitative assessments of research objectives, design, population sampling strategies, depth of analysis, risk of bias, and interpretation of results.
A total of 31 analytical articles have been produced for the application of these standards;
All articles were published between 2009 and 2014.
We also reviewed the tobacco product Center (CTP)daily news (
News clips from the clip service)
Relevant information.
Analysis of CTP AEs database related to e-
During the period from 2008 to December 31, 2013, the use of cigarettes voluntarily reported to the FDA/CTP was reviewed for its nature, severity, possible HF contributions and impact on product labeling.
AE definition of E-application
Cigarettes are adapted according to the concepts in regulations 4 and Guide 5 for research drugs and non-research drugs
Prescription products.
Electronic label analysis
12 e-cigarette products labeled by FDA/CTPThe
Cigarette products from 9 manufacturers (table 1)
7-12 was analyzed using tools developed by FDA.
The tool is an unweighted list of 65 elements in a broad category, including claims; package design;
Product and manufacturer identification on the outer packaging and main parts;
Content, notability, readability and ease of health precautions;
And instructions for use.
We rated each tag element as \"now\" or \"absent\", including qualitative markers, and reported findings using descriptive statistics.
Samples include products evaluated in published label analysis (n=7)
At the end of 2012, a product considered by one or more independent analysts to be popular (n=8)
And the products that the FDA has received the AE report (n=7).
I sample includes rechargeable starter kit, cartridge and cartomizers, electronics
Liquid for filling ink cartridges and disposable electronic productscigarettes. FDA-
Approved labels for prescription 13 and non-prescription 13
Prescription nicotine replacement product 14 for reference.
All levels of the packaging label were reviewed and the product was measured to assess whether there was a potential choking hazard and to check if the label correctly addressed the risk.
View this table: view an example of a spreadsheet
Cigarette products analyzed by CTP for labeling (n=12)
Based on a recent comprehensive review of e-commerce in the United States, users and the use environment as a result
Pepper and Brewer cigarette users in 15 adults
Cigarette use in the United States has increased from 1% in 200916 to 6% in 201117, and current smokers are more likely to use e-cigarettes.
Cigarettes than before and beforesmokers.
In recent years, the number of American teenagers and young people using e-cigarettes has also increased.
15, 19-23 additional data describing the user group is limited.
Although a study on e-commerce
Cigarette use in patients with mental division was identified, and 24 other studies that did not assess a specific user group (
For example, scenario users such as pregnant women, nursing mothers, elderly people, patients during the period of surgery or hospitalized, users with chronic medical diseases/disabilities)
Confirmed. Given that e-
Cigarettes are more complex than traditional cigarettes, and some may require product assembly, component replacement, or both, electronics
Cigarette users may need additional skills to ensure proper use that is not required by traditional cigarette users.
25 studies on the use environment have not been identified, but e-
Cigarettes can be used in working environment and public places.
There is no article specifically analyzing electronic products in electronic cigarette product design
The operational requirements or complexity of cigarettes are determined.
A us study found ink cartridge leaks and noted that it is difficult to avoid contact with electronic devices
Liquid when assembling or removing cartridges.
A study in Italy identified the design problem: specifically, the product cannot be used as recommended, the product cannot produce fog when puffed, the nebulizer must be replaced and the charger replaced immediately.
26 users said they accepted e-commerce
By raising manufacturing standards, cigarettes can be improved by providing at least 24 hours of battery capacity, by reducing the weight of the product and replacing the hard plastic mouth.
A study from the Czech Republic found that 4% of subjects (n=262)
The unspecified technical difficulties lead to unsatisfactory products.
27 design problems found in 2010 surveys conducted in the UK and France include leaked Electronics
Liquid, \"break down\" product, worried that \"steam\" is not concentrated, difficult to breathe in, the ink cartridge and battery duration is not long enough.
28 No article on the application of HFE in e-commerce
The design of cigarette products was determined.
Literature Review on e-commerce
Electronic labeling and packaging of 12 products
Cigarette labeling9-12 29-36 (
See online Supplement Table S1): 11 studied e-
Desktop methods 9, 11, 12, 29-36 are used for liquid content;
The three broader aspects of product labels 10, 11, 31 were evaluated;
Two others commented on the packaging design.
31. 36 six studies were based on the United States, 9, 10, 29, 30, 33, 35, and the other five included one or more emails
Cigarette brands sold in the United States.
11, 12, 31, 34, 36 of 11 studies analyzed the accuracy of labeled nicotine in e-
The liquid found in one or more samples was higher than the labeled amount, 9, 11, 12, 32-34, and three studies found that the nicotine content was more than twice as high.
9, 11, 32 laboratory analyses have also identified components of concern, including nicotine-
Related Impurities, 9, 31, 34 kinds of poison or laboratory reagents, drugs.
9. 31 other published labeling and packaging analyses identify global or specific issues.
Cheah et al analyzed the product design features, content and eight label elements of 19 electronic labels
Brand of cigarettes (
Including three brands in the US)
It is also concluded that inadequate and misleading information is common in product labeling and packaging.
Trtchounian and Talbot10 analyzed 25 elements of the starter kit instructions for six products from five US manufacturers and concluded that there was a lack of importance regarding product content, use and warnings
According to an analysis in Britain,
The analyzed cigarette packaging did not have a choking warning.
A study found that six electrons
Evaluation of cigarette packaging design in childrenresistant (C-R)
Although it contains e-
Liquid with high concentration of nicotine (14. 8–87. 2u2005mg/mL).
Analysis of electronic labels
FDA/CTPConcerns cigarette products for products and manufacturer labels are identified in most samples analyzed (
8 out of 12 products have no batch number).
Most cartridges seem to be interchanged.
There is a problem with the ingredient labels for all products: five products do not provide the ingredients, and of the seven product packages that list the ingredients, two do not provide consistent information on all packaging levels. One e-
Liquid packaging lists potentially fatal allergens peanuts as an ingredient but does not provide a warning.
10 nicotine-
The content label containing the product is ambiguous in terms of qualitative descriptors or inaccurate Quantitative symbols.
Eight products, including two nicotine-free products, warn of potential nicotine toxicity.
Four people warned of the possibility of nicotine poisoning, but no one warned of the possibility of death.
Health warnings are listed on seven outer packaging labels;
However, warning and warning content accounts for less than 30% of the back panel and 20-100% of the side panel, which is printed in small print and may be unobtrusive to the reader.
39-41 there is no product warning of the possibility of excessive heat, explosion or burn.
Two products known as nonflammable.
5 of the 12 products do not include instructions for use.
Instructions for seven products no steps are providedby-
Step instructions are written above or both in grade 8.
39. All products are not labeled, indicating that the product is used for smoking cessation;
However, a product insert contains suggestions to stop the lifestyle, and the labels of the five products indicate that the product is less risky than traditional cigarettes.
All products contain at least one ingredient that meets the risk of suffocation.
Iii 43 only one starter kit warns this danger directly on an external package, but the font is small.
Three cartridges and two electrons
Liquid seems to have C-
S. Consumer Guide.
Eight products have been warned not to touch children \".
No C for all three products.
There is also no \"child warning\" for the R package \".
Electronic-related AEs
Literature Review of aes events related to e-commerce
Cigarette product exposure reported to the American Association of poisoning Control Centers (AAPCC)
An increase of 42% over 2011 (n=256)to 2012 (n=438).
More than 30% of cases involve children under 5 years of age (n=84 in 2011; n=172 in 2012)
56% increase in intentional abuse (
2011 n = 12,2012 n = 27).
Approximately 15% of exposure is allergic or special, and 25% require medical treatment.
46. 47 cases of intentional drug abuse include injection of e-liquid (
The concentration of nicotine in serum is ng/mL)
48 and suicide attempts at ingestion and skin application e-liquid.
Limited information about states
The data from the horizontal summary poisoning Control Center indicate that the common route of contact for children is intake, inhalation, and skin contact.
50-53 outside the United States, e-
Two adults in Denmark54 and an Israeli toddler reportedly died of suicide three times.
There are 14 e-
Eight people were injured, at least two of them. users;
Charging equipment exploded.
Two explosions occurred during use, causing burns, oral injuries and unilateral blindness.
57 disposable electronics
The cigarette exploded when it was removed from the package, causing sensory damage and property damage.
11 explosions during the charging of 58 equipment caused burns (n=2)
Smoke inhalation injury of 59 and 60 (n=2)
60-62 and loss of property (n=8).
Six reports suggest possible users-
Product interaction: three description products are left unattended at charging52, 63, 66 and 68;
Two states indicate a lack of warning or charging instructions for the product, 60, 66 and one state indicate that the charger is used for different electronic devices
Cigarette products may have been used.
67 product complaints and AEs analysis voluntarily reported to FDAFDA received the first email
AE report of cigarettes in August 2008.
As of December 31, 2013, FDA/CTP received 91 voluntary reports of complaints about e-commerce-related products or health effects
26 (29%)
The report may have HF contributions.
The six reports specifically deal with product quality, performance, labeling or advertising, and do not involve AEs.
Of the 20 reports containing AEs, 8 were serious, including infants who died of suffocation due to taste boxes, 3 adults and 1 child burned by 4 explosions, 59
One cartridge overheating, one intentional double use of traditional cigarettes)
And a possible nicotine overdose in e-
Liquid intake. Twelve non-
Serious AE reports include
Specific actual complaints related to advertising, labeling or website issues (n=4), leakage of e-
Liquid that causes stimulation of the mouth or hand (n=3);
Oral burns caused by overheating or explosion (n=2);
Harmful smells and flavors that cause breathing, stomach and physical symptoms (n=1);
Continuous taste related to difficulty in using the charger (n=1);
And possibly marijuana adulterated products (n=1).
Complaints related to advertising, labeling, brochures or websites include unconfirmed claims, improper advertising in the healthcare provider\'s office, lack of product brochures;
Inappropriate label (
Products labeled nicotinefree and harm-
Although the FDA website information is free
Cigarettes may contain nicotine \")
Lack of health warnings in a retail environment makes it difficult to reach the \"Company \".
According to the recent comprehensive review of e-commerce in the United States, users and use environment
Pepper and Brewer cigarette users in 15 adults
Cigarette use in the United States has increased from 1% in 200916 to 6% in 201117, and current smokers are more likely to use e-cigarettes.
Cigarettes than before and beforesmokers.
In recent years, the number of American teenagers and young people using e-cigarettes has also increased.
15, 19-23 additional data describing the user group is limited.
Although a study on e-commerce
Cigarette use in patients with mental division was identified, and 24 other studies that did not assess a specific user group (
For example, scenario users such as pregnant women, nursing mothers, elderly people, patients during the period of surgery or hospitalized, users with chronic medical diseases/disabilities)
Confirmed. Given that e-
Cigarettes are more complex than traditional cigarettes, and some may require product assembly, component replacement, or both, electronics
Cigarette users may need additional skills to ensure proper use that is not required by traditional cigarette users.
25 studies on the use environment have not been identified, but e-
Cigarettes can be used in working environment and public places.
There is no article specifically analyzing electronic products in electronic cigarette product design
The operational requirements or complexity of cigarettes are determined.
A us study found ink cartridge leaks and noted that it is difficult to avoid contact with electronic devices
Liquid when assembling or removing cartridges.
A study in Italy identified the design problem: specifically, the product cannot be used as recommended, the product cannot produce fog when puffed, the nebulizer must be replaced and the charger replaced immediately.
26 users said they accepted e-commerce
By raising manufacturing standards, cigarettes can be improved by providing at least 24 hours of battery capacity, by reducing the weight of the product and replacing the hard plastic mouth.
A study from the Czech Republic found that 4% of subjects (n=262)
The unspecified technical difficulties lead to unsatisfactory products.
27 design problems found in 2010 surveys conducted in the UK and France include leaked Electronics
Liquid, \"break down\" product, worried that \"steam\" is not concentrated, difficult to breathe in, the ink cartridge and battery duration is not long enough.
28 No article on the application of HFE in e-commerce
The design of cigarette products was determined.
Literature Review on e-commerce
Electronic labeling and packaging of 12 products
Cigarette labeling9-12 29-36 (
See online Supplement Table S1): 11 studied e-
Desktop methods 9, 11, 12, 29-36 are used for liquid content;
The three broader aspects of product labels 10, 11, 31 were evaluated;
Two others commented on the packaging design.
31. 36 six studies were based on the United States, 9, 10, 29, 30, 33, 35, and the other five included one or more emails
Cigarette brands sold in the United States.
11, 12, 31, 34, 36 of 11 studies analyzed the accuracy of labeled nicotine in e-
The liquid found in one or more samples was higher than the labeled amount, 9, 11, 12, 32-34, and three studies found that the nicotine content was more than twice as high.
9, 11, 32 laboratory analyses have also identified components of concern, including nicotine-
Related Impurities, 9, 31, 34 kinds of poison or laboratory reagents, drugs.
9. 31 other published labeling and packaging analyses identify global or specific issues.
Cheah et al analyzed the product design features, content and eight label elements of 19 electronic labels
Brand of cigarettes (
Including three brands in the US)
It is also concluded that inadequate and misleading information is common in product labeling and packaging.
Trtchounian and Talbot10 analyzed 25 elements of the starter kit instructions for six products from five US manufacturers and concluded that there was a lack of importance regarding product content, use and warnings
According to an analysis in Britain,
The analyzed cigarette packaging did not have a choking warning.
A study found that six electrons
Evaluation of cigarette packaging design in childrenresistant (C-R)
Although it contains e-
Liquid with high concentration of nicotine (14. 8–87. 2u2005mg/mL).
33 results of literature review on e-commerce
Electronic labeling and packaging of 12 products
Cigarette labeling9-12 29-36 (
See online Supplement Table S1): 11 studied e-
Desktop methods 9, 11, 12, 29-36 are used for liquid content;
The three broader aspects of product labels 10, 11, 31 were evaluated;
Two others commented on the packaging design.
31. 36 six studies were based on the United States, 9, 10, 29, 30, 33, 35, and the other five included one or more emails
Cigarette brands sold in the United States.
11, 12, 31, 34, 36 of 11 studies analyzed the accuracy of labeled nicotine in e-
The liquid found in one or more samples was higher than the labeled amount, 9, 11, 12, 32-34, and three studies found that the nicotine content was more than twice as high.
9, 11, 32 laboratory analyses have also identified components of concern, including nicotine-
Related Impurities, 9, 31, 34 kinds of poison or laboratory reagents, drugs.
9. 31 other published labeling and packaging analyses identify global or specific issues.
Cheah et al analyzed the product design features, content and eight label elements of 19 electronic labels
Brand of cigarettes (
Including three brands in the US)
It is also concluded that inadequate and misleading information is common in product labeling and packaging.
Trtchounian and Talbot10 analyzed 25 elements of the starter kit instructions for six products from five US manufacturers and concluded that there was a lack of importance regarding product content, use and warnings
According to an analysis in Britain,
The analyzed cigarette packaging did not have a choking warning.
A study found that six electrons
Evaluation of cigarette packaging design in childrenresistant (C-R)
Although it contains e-
Liquid with high concentration of nicotine (14. 8–87. 2u2005mg/mL).
Analysis of electronic labels
FDA/CTPConcerns cigarette products for products and manufacturer labels are identified in most samples analyzed (
8 out of 12 products have no batch number).
Most cartridges seem to be interchanged.
There is a problem with the ingredient labels for all products: five products do not provide the ingredients, and of the seven product packages that list the ingredients, two do not provide consistent information on all packaging levels. One e-
Liquid packaging lists potentially fatal allergens peanuts as an ingredient but does not provide a warning.
10 nicotine-
The content label containing the product is ambiguous in terms of qualitative descriptors or inaccurate Quantitative symbols.
Eight products, including two nicotine-free products, warn of potential nicotine toxicity.
Four people warned of the possibility of nicotine poisoning, but no one warned of the possibility of death.
Health warnings are listed on seven outer packaging labels;
However, warning and warning content accounts for less than 30% of the back panel and 20-100% of the side panel, which is printed in small print and may be unobtrusive to the reader.
39-41 there is no product warning of the possibility of excessive heat, explosion or burn.
Two products known as nonflammable.
5 of the 12 products do not include instructions for use.
Instructions for seven products no steps are providedby-
Step instructions are written above or both in grade 8.
39. All products are not labeled, indicating that the product is used for smoking cessation;
However, a product insert contains suggestions to stop the lifestyle, and the labels of the five products indicate that the product is less risky than traditional cigarettes.
All products contain at least one ingredient that meets the risk of suffocation.
Iii 43 only one starter kit warns this danger directly on an external package, but the font is small.
Three cartridges and two electrons
Liquid seems to have C-
S. Consumer Guide.
Eight products have been warned not to touch children \".
No C for all three products.
There is also no \"child warning\" for the R package \".
Electronic-related AEs
Literature Review of aes events related to e-commerce
Cigarette product exposure reported to the American Association of poisoning Control Centers (AAPCC)
An increase of 42% over 2011 (n=256)to 2012 (n=438).
More than 30% of cases involve children under 5 years of age (n=84 in 2011; n=172 in 2012)
56% increase in intentional abuse (
2011 n = 12,2012 n = 27).
Approximately 15% of exposure is allergic or special, and 25% require medical treatment.
46. 47 cases of intentional drug abuse include injection of e-liquid (
The concentration of nicotine in serum is ng/mL)
48 and suicide attempts at ingestion and skin application e-liquid.
Limited information about states
The data from the horizontal summary poisoning Control Center indicate that the common route of contact for children is intake, inhalation, and skin contact.
50-53 outside the United States, e-
Two adults in Denmark54 and an Israeli toddler reportedly died of suicide three times.
There are 14 e-
Eight people were injured, at least two of them. users;
Charging equipment exploded.
Two explosions occurred during use, causing burns, oral injuries and unilateral blindness.
57 disposable electronics
The cigarette exploded when it was removed from the package, causing sensory damage and property damage.
11 explosions during the charging of 58 equipment caused burns (n=2)
Smoke inhalation injury of 59 and 60 (n=2)
60-62 and loss of property (n=8).
Six reports suggest possible users-
Product interaction: three description products are left unattended at charging52, 63, 66 and 68;
Two states indicate a lack of warning or charging instructions for the product, 60, 66 and one state indicate that the charger is used for different electronic devices
Cigarette products may have been used.
67 review of AEsEvents literature and electronics
Cigarette product exposure reported to the American Association of poisoning Control Centers (AAPCC)
An increase of 42% over 2011 (n=256)to 2012 (n=438).
More than 30% of cases involve children under 5 years of age (n=84 in 2011; n=172 in 2012)
56% increase in intentional abuse (
2011 n = 12,2012 n = 27).
Approximately 15% of exposure is allergic or special, and 25% require medical treatment.
46. 47 cases of intentional drug abuse include injection of e-liquid (
The concentration of nicotine in serum is ng/mL)
48 and suicide attempts at ingestion and skin application e-liquid.
Limited information about states
The data from the horizontal summary poisoning Control Center indicate that the common route of contact for children is intake, inhalation, and skin contact.
50-53 outside the United States, e-
Two adults in Denmark54 and an Israeli toddler reportedly died of suicide three times.
There are 14 e-
Eight people were injured, at least two of them. users;
Charging equipment exploded.
Two explosions occurred during use, causing burns, oral injuries and unilateral blindness.
57 disposable electronics
The cigarette exploded when it was removed from the package, causing sensory damage and property damage.
11 explosions during the charging of 58 equipment caused burns (n=2)
Smoke inhalation injury of 59 and 60 (n=2)
60-62 and loss of property (n=8).
Six reports suggest possible users-
Product interaction: three description products are left unattended at charging52, 63, 66 and 68;
Two states indicate a lack of warning or charging instructions for the product, 60, 66 and one state indicate that the charger is used for different electronic devices
Cigarette products may have been used.
67 product complaints and AEs analysis voluntarily reported to FDAFDA received the first email
AE report of cigarettes in August 2008.
As of December 31, 2013, FDA/CTP received 91 voluntary reports of complaints about e-commerce-related products or health effects
26 (29%)
The report may have HF contributions.
The six reports specifically deal with product quality, performance, labeling or advertising, and do not involve AEs.
Of the 20 reports containing AEs, 8 were serious, including infants who died of suffocation due to taste boxes, 3 adults and 1 child burned by 4 explosions, 59
One cartridge overheating, one intentional double use of traditional cigarettes)
And a possible nicotine in e-
Liquid intake. Twelve non-
Serious AE reports include
Specific actual complaints related to advertising, labeling or website issues (n=4), leakage of e-
Liquid that causes stimulation of the mouth or hand (n=3);
Oral burns caused by overheating or explosion (n=2);
Harmful smells and flavors that cause breathing, stomach and physical symptoms (n=1);
Continuous taste related to difficulty in using the charger (n=1);
And possibly marijuana adulterated products (n=1).
Complaints related to advertising, labeling, brochures or websites include unconfirmed claims, improper advertising in the healthcare provider\'s office, lack of product brochures;
Inappropriate label (
Products labeled nicotinefree and harm-
Although the FDA website information is free
Cigarettes may contain nicotine \")
Lack of health warnings in a retail environment makes it difficult to reach the \"Company \".
Data on HF\'s contribution to e-
The use of cigarettes is limited, many use
HFE can solve related problems in the process of product design, manufacturing and distribution. Currently, e-
Cigarette production in the United States is unregulated.
The parameters vary greatly, such as the airflow rate required to produce the aerosol, the length of the pressure drop and duration box, and the e-
Brand of cigarettes.
70 e-cigarette users although the user features have been explored in several studies, and the majority of e-cigarette users have been consistently identified
The study found that cigarette users, as smokers of traditional cigarette products
The data are limited and inconsistent in the study.
In those with potential medical conditions, including asthma and allergies, 2 and young, young and pregnant women, the risk of individual users may be greater.
Given the complexity of some emails
Users with cigarette products, reduced manual dexterity, visual/hearing impairment, or limited cognitive skills may face higher risk of use.
It is not yet clear the dual use of e-
Cigarettes and other nicotine
Products containing nicotine can lead to increased nicotine toxicity and risk of useRelated hazards.
Longitudinal national data, such as data from population assessments of ongoing tobacco and health studies, a collaborative project between NIH and FDA/CTP to better understand e-commerce
Group of cigarette users.
E-cigarette use environment e-cigarette can be used in many environments, including home, public space (
Parks and restaurants)
71 and mobile environment ((Car).
Although some states and localities have legislation restricting the use of e-commerce by the public
Number and type of cigarette, 71 e-commerce environment
The number of cigarettes currently used seems to be higher than that of traditional cigarettes.
Conditions such as ambient temperature and user interference may affect the use of the appropriate product 2, and the storage environment may affect the quality, effectiveness and function of the product.
In particular, environments where reusable devices are charged can have significant risk consequences.
Research is required to fully describe the e-commerce environment
Use and store cigarettes.
Electronic cigarette design and quality of electronic cigarette
There are many kinds of cigarettes with insufficient features.
Some known and potentially related electronics
By improving product design and quality standards, cigarette risk, such as damage and damage associated with an explosion, may be mitigated.
For example, lithium batteries used in e-
Due to the ability to store a large amount of energy in a compact space, cigarettes are at risk of overheating, explosion and electrolyte leakage.
Adopting standardized manufacturing techniques and improved quality control processes can reduce battery hazards by reducing design defects and manufacturing defects.
These changes may also improve tolerances related to the environment and storage conditions experienced during normal consumer use.
In addition to design and manufacturing defects, the improper use and handling of batteries by consumers may lead to a situation called \"heat exhaustion\" in which the temperature of the internal battery increases, cause a fire or explosion.
72 industry use-
Verified Design security function (
Such as over-charge protection circuit and thermal power failure-
Offs and internal over-voltage release mechanism)
73 and instructions for use, including proper care and handling of batteries, may help to prevent heat from getting out of control. Some e-
Cigarettes can be modified to be used in other ways than expected, which can lead to malicious adulterated, transport of higher concentrations of nicotine and toxins, and e-
Liquids such as sesame oil and wax.
25 battery stacking and \"drive\" iv are examples of how users can increase nicotine delivery.
In addition to expectations, the design to prevent product modifications and use may help to prevent or reduce adverse health effects associated with adulterated products.
2 label and user interface literature, AE report review and label analysis
Inadequacies of cigarette labels, including information that is vague, incomplete or misleading, and information that is provided in the font that may be inconspicuous to the user.
Given the complexity of e-commerce
E-commerce may require cigarette products and potential risks, instructions to ensure proper use and adequate safety labelingcigarettes.
25 for example, all electrons
Cigarettes in the CTP label analysis contain a small portion of the risk of suffocation for children and pets, and there are reported fatal suffocation incidents.
Products with C
The R package is designed and comes with a choking hazard warning that can reduce or prevent choking hazards.
In addition, nicotine intake-containing e-
Liquid, especially liquid with high concentration (eg, 87.
2 mg/ml of nicotine)
32 can be poisoned, v, 74, and poisoning incidents have been reported.
It is feared that nicotine deposited on the surface can be converted into carcinogens and then inhaled or ingested by users and non-users. users.
75, 76 although the degree of risk of overdoses and poisoning events remains uncertain, sufficient product labels can warn of nicotine exposure and toxicity, and C-
Packaging helps reduce risk.
Incorporating HF approach into e-commerce
Additional information on e-cigarette risk assessment
In order to apply the HFE risk assessment strategy, cigarette users, usage environment and product-user interface are required.
The HF methods for analysis include functional and task analysis, heuristic analysis, and expert reviews.
Methods of experience (use studies)
Get information from the actual or simulated use of the product.
Usability testing before product marketing may reveal design issues and improve product labeling and direction of use.
2 Post-marketing monitoring and evaluation is also critical for monitoring AEs and capturing unexpected user errors;
This can inform consumer education and the development of additional safeguards to improve product design.
To incorporate this review, an article must be related to HF, written in English and focused on the US market.
Therefore, some articles may be ignored.
AEs submitted to FDA is from voluntary journalists and may not include all cases or may lack accurate or complete information.
For our label analysis, we are not the first to open some samples, which may limit our ability to review all packaging levels and may also affect the appearance of tampering
The packaging features are obvious.
Our assumptions about the level of NicQuid packaging for retail consumers®The sample and the interpretation of the contents of fuzzy labels such as numbers and text descriptors are not confirmed by the manufacturer.
We analyzed 12.
Cigarette products that may or may not represent e-commerce
General cigarette products. One-
The quarter of our sample comes from a manufacturer (NJOY)
Although the decision to be incorporated is consistent with the market share of the product 12 and other published labeling analyses.
Electronic cigarettes are becoming more and more popular and developing rapidly.
Some of the defects we found on the label, especially for the earliest samples obtained, may have been resolved by the industry.
Although the features of e-cigarette users have been explored in several studies, and the majority of e-cigarette users have been consistently identified
The study found that cigarette users, as smokers of traditional cigarette products
The data are limited and inconsistent in the study.
In those with potential medical conditions, including asthma and allergies, 2 and young, young and pregnant women, the risk of individual users may be greater.
Given the complexity of some emails
Users with cigarette products, reduced manual dexterity, visual/hearing impairment, or limited cognitive skills may face higher risk of use.
It is not yet clear the dual use of e-
Cigarettes and other nicotine
Products containing nicotine can lead to increased nicotine toxicity and risk of useRelated hazards.
Longitudinal national data, such as data from population assessments of ongoing tobacco and health studies, a collaborative project between NIH and FDA/CTP to better understand e-commerce
Group of cigarette users.
E-cigarette use environment e-cigarette can be used in many environments, including home, public space (
Parks and restaurants)
71 and mobile environment ((Car).
Although some states and localities have legislation restricting the use of e-commerce by the public
Number and type of cigarette, 71 e-commerce environment
The number of cigarettes currently used seems to be higher than that of traditional cigarettes.
Conditions such as ambient temperature and user interference may affect the use of the appropriate product 2, and the storage environment may affect the quality, effectiveness and function of the product.
In particular, environments where reusable devices are charged can have significant risk consequences.
Research is required to fully describe the e-commerce environment
Use and store cigarettes.
Electronic cigarette design and quality of electronic cigarette
There are many kinds of cigarettes with insufficient features.
Some known and potentially related electronics
By improving product design and quality standards, cigarette risk, such as damage and damage associated with an explosion, may be mitigated.
For example, lithium batteries used in e-
Due to the ability to store a large amount of energy in a compact space, cigarettes are at risk of overheating, explosion and electrolyte leakage.
Adopting standardized manufacturing techniques and improved quality control processes can reduce battery hazards by reducing design defects and manufacturing defects.
These changes may also improve tolerances related to the environment and storage conditions experienced during normal consumer use.
In addition to design and manufacturing defects, the improper use and handling of batteries by consumers may lead to a situation called \"heat exhaustion\" in which the temperature of the internal battery increases, cause a fire or explosion.
72 industry use-
Verified Design security function (
Such as over-charge protection circuit and thermal power failure-
Offs and internal over-voltage release mechanism)
73 and instructions for use, including proper care and handling of batteries, may help to prevent heat from getting out of control. Some e-
Cigarettes can be modified to be used in other ways than expected, which can lead to malicious adulterated, transport of higher concentrations of nicotine and toxins, and e-
Liquids such as sesame oil and wax.
25 battery stacking and \"drive\" iv are examples of how users can increase nicotine delivery.
In addition to expectations, the design to prevent product modifications and use may help to prevent or reduce adverse health effects associated with adulterated products.
2 label and user interface literature, AE report review and label analysis
Inadequacies of cigarette labels, including information that is vague, incomplete or misleading, and information that is provided in the font that may be inconspicuous to the user.
Given the complexity of e-commerce
E-commerce may require cigarette products and potential risks, instructions to ensure proper use and adequate safety labelingcigarettes.
25 for example, all electrons
Cigarettes in the CTP label analysis contain a small portion of the risk of suffocation for children and pets, and there are reported fatal suffocation incidents.
Products with C
The R package is designed and comes with a choking hazard warning that can reduce or prevent choking hazards.
In addition, nicotine intake-containing e-
Liquid, especially liquid with high concentration (eg, 87.
2 mg/ml of nicotine)
32 can be poisoned, v, 74, and poisoning incidents have been reported.
It is feared that nicotine deposited on the surface can be converted into carcinogens and then inhaled or ingested by users and non-users. users.
75, 76 although the degree of risk of overdoses and poisoning events remains uncertain, sufficient product labels can warn of nicotine exposure and toxicity, and C-
Packaging helps reduce risk.
Incorporating HF approach into e-commerce
Additional information on e-cigarette risk assessment
In order to apply the HFE risk assessment strategy, cigarette users, usage environment and product-user interface are required.
The HF methods for analysis include functional and task analysis, heuristic analysis, and expert reviews.
Methods of experience (use studies)
Get information from the actual or simulated use of the product.
Usability testing before product marketing may reveal design issues and improve product labeling and direction of use.
2 Post-marketing monitoring and evaluation is also critical for monitoring AEs and capturing unexpected user errors;
This can inform consumer education and the development of additional safeguards to improve product design.
To incorporate this review, an article must be related to HF, written in English and focused on the US market.
Therefore, some articles may be ignored.
AEs submitted to FDA is from voluntary journalists and may not include all cases or may lack accurate or complete information.
For our label analysis, we are not the first to open some samples, which may limit our ability to review all packaging levels and may also affect the appearance of tampering
The packaging features are obvious.
Our assumptions about the level of NicQuid packaging for retail consumers®The sample and the interpretation of the contents of fuzzy labels such as numbers and text descriptors are not confirmed by the manufacturer.
We analyzed 12.
Cigarette products that may or may not represent e-commerce
General cigarette products. One-
The quarter of our sample comes from a manufacturer (NJOY)
Although the decision to be incorporated is consistent with the market share of the product 12 and other published labeling analyses.
Electronic cigarettes are becoming more and more popular and developing rapidly.
Some of the defects we found on the label, especially for the earliest samples obtained, may have been resolved by the industry.
Conclusion HFE pair and e-
Cigarettes are not sufficiently characterized.
HF risk management strategy may help solve e-commerce
Cigarette related hazards.
Given the complexity of e-commerce
Cigarette products and high concentrations of nicotine available for use, improvements in current labeling may help prevent or mitigate risks associated with electronic labelingcigarette use.
AEs reported for e-cigarettes (
Explosions, burns, poisoning, choking death and nicotine overdose)
Costs can be reduced by improving product labeling and instructions, improving product and packaging design, and improving manufacturing quality control.
Future research focuses on collecting data to fully describe E-Commerce
Cigarette users, User Environments, identifying potential hazards associated with typical and atypical use, assessing product complexity, identifying appropriate manufacturing standards and designing safety features, and identifying the effectiveness of risk mitigation strategies.
The supplementary content of this article is the first comprehensive review of the application of human factors engineering principles to e-commerce. cigarette-
Related hazards.
Adverse health effects and product failure reports related to e-commerce
As the popularity of these products increases, the use of cigarettes is also increasing, and human factors seem to lead to a large number of incidents, including some serious ones.
Further research is needed on human factors that may lead to or contribute to e-commercecigarette-
Related adverse health effects and product failures and identify appropriate and effective risk mitigation strategies.
We would like to thank Dr. Cathy berginger, Priscilla Callahan-
Lyon, Nancy Zhang, Ii-
Chen Lun, Caroline de Resler, Colin hussten and Sarah E.
Johnson, and Mr. Paul Aguilar and Ms. Smith.
Deborah Neveleff, thank you for your support for this project.
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