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Human factors engineering and design validation for the redesigned follitropin alfa pen injection device.

Mahony MC, Patterson P, Hayward B, North R, Green D - Expert Opin Drug Deliv (2015)

Bottom Line: A failure modes and effects analysis identified hazards and harms potentially caused by use errors; risk-control measures were implemented to ensure acceptable device use risk management.In the first validation study (49 users, 343 simulated injections), in the FN group, one observed critical use error resulted in a device design modification and another in an IFU change.Simulated-use testing demonstrated that the redesigned pen can be used to administer follitropin alfa effectively and safely.

View Article: PubMed Central - PubMed

Affiliation: EMD Serono, Inc. , One Technology Place, Rockland, MA 02370 , USA +1 781 681 2438 ; +1 781 681 2900 ; mary.mahony@emdserono.com.

ABSTRACT

Objectives: To demonstrate, using human factors engineering (HFE), that a redesigned, pre-filled, ready-to-use, pre-asembled follitropin alfa pen can be used to administer prescribed follitropin alfa doses safely and accurately.

Methods: A failure modes and effects analysis identified hazards and harms potentially caused by use errors; risk-control measures were implemented to ensure acceptable device use risk management. Participants were women with infertility, their significant others, and fertility nurse (FN) professionals. Preliminary testing included 'Instructions for Use' (IFU) and pre-validation studies. Validation studies used simulated injections in a representative use environment; participants received prior training on pen use.

Results: User performance in preliminary testing led to IFU revisions and a change to outer needle cap design to mitigate needle stick potential. In the first validation study (49 users, 343 simulated injections), in the FN group, one observed critical use error resulted in a device design modification and another in an IFU change. A second validation study tested the mitigation strategies; previously reported use errors were not repeated.

Conclusions: Through an iterative process involving a series of studies, modifications were made to the pen design and IFU. Simulated-use testing demonstrated that the redesigned pen can be used to administer follitropin alfa effectively and safely.

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The risk management process for addressing use-related risks with the redesigned follitropin alfa pen.
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Figure 0002: The risk management process for addressing use-related risks with the redesigned follitropin alfa pen.

Mentions: HFE includes multiple steps and follows an iterative process (Figure 2) that includes defining user populations and the use environment, a hierarchical analysis of tasks, development of a use error mitigation plan, and testing use error mitigation. An important first step includes the risk management plan and performing use-related risk analysis (failure modes and effects analysis [FMEA]). Following risk assessment, a vital part of the HFE process is simulated-use testing, which involves assessing the interactions between the users and the device in an environment that mimics the real-world experience of the user and culminates in simulated-use validation tests. A medical device is considered safe and effective if it is demonstrated that the control strategies are effective in reducing risk to as low as reasonably possible so that users may complete medication administration without critical or serious errors resulting in incorrect dosing or other patient or user harm.


Human factors engineering and design validation for the redesigned follitropin alfa pen injection device.

Mahony MC, Patterson P, Hayward B, North R, Green D - Expert Opin Drug Deliv (2015)

The risk management process for addressing use-related risks with the redesigned follitropin alfa pen.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4496816&req=5

Figure 0002: The risk management process for addressing use-related risks with the redesigned follitropin alfa pen.
Mentions: HFE includes multiple steps and follows an iterative process (Figure 2) that includes defining user populations and the use environment, a hierarchical analysis of tasks, development of a use error mitigation plan, and testing use error mitigation. An important first step includes the risk management plan and performing use-related risk analysis (failure modes and effects analysis [FMEA]). Following risk assessment, a vital part of the HFE process is simulated-use testing, which involves assessing the interactions between the users and the device in an environment that mimics the real-world experience of the user and culminates in simulated-use validation tests. A medical device is considered safe and effective if it is demonstrated that the control strategies are effective in reducing risk to as low as reasonably possible so that users may complete medication administration without critical or serious errors resulting in incorrect dosing or other patient or user harm.

Bottom Line: A failure modes and effects analysis identified hazards and harms potentially caused by use errors; risk-control measures were implemented to ensure acceptable device use risk management.In the first validation study (49 users, 343 simulated injections), in the FN group, one observed critical use error resulted in a device design modification and another in an IFU change.Simulated-use testing demonstrated that the redesigned pen can be used to administer follitropin alfa effectively and safely.

View Article: PubMed Central - PubMed

Affiliation: EMD Serono, Inc. , One Technology Place, Rockland, MA 02370 , USA +1 781 681 2438 ; +1 781 681 2900 ; mary.mahony@emdserono.com.

ABSTRACT

Objectives: To demonstrate, using human factors engineering (HFE), that a redesigned, pre-filled, ready-to-use, pre-asembled follitropin alfa pen can be used to administer prescribed follitropin alfa doses safely and accurately.

Methods: A failure modes and effects analysis identified hazards and harms potentially caused by use errors; risk-control measures were implemented to ensure acceptable device use risk management. Participants were women with infertility, their significant others, and fertility nurse (FN) professionals. Preliminary testing included 'Instructions for Use' (IFU) and pre-validation studies. Validation studies used simulated injections in a representative use environment; participants received prior training on pen use.

Results: User performance in preliminary testing led to IFU revisions and a change to outer needle cap design to mitigate needle stick potential. In the first validation study (49 users, 343 simulated injections), in the FN group, one observed critical use error resulted in a device design modification and another in an IFU change. A second validation study tested the mitigation strategies; previously reported use errors were not repeated.

Conclusions: Through an iterative process involving a series of studies, modifications were made to the pen design and IFU. Simulated-use testing demonstrated that the redesigned pen can be used to administer follitropin alfa effectively and safely.

Show MeSH
Related in: MedlinePlus