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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 redesigned follitropin alfa pen injection device.
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Figure 0001: The redesigned follitropin alfa pen injection device.

Mentions: The redesigned follitropin alfa (r-hFSH) pen injector (GONAL-f®; pre-filled pen; Merck Serono, Geneva, Switzerland, a subsidiary of Merck KGaA, Darmstadt, Germany) was approved by the European Commission in May 2011 [4]. It was since approved by the US FDA in October 2013 (GONAL-f RFF® Redi-ject™; EMD Serono, Inc., Rockland, MA, USA, a subsidiary of Merck KGaA, Darmstadt, Germany) [5], and the pen has now been launched in 65 countries worldwide; in countries other than the USA, the pen is called GONAL-f Prefilled Pen. After attaching the needle and setting the dose, the redesigned pen (Figure 1) is a disposable, pre-filled, ready-to-use, pre-assembled pen that includes a number of feature modifications to the previous pen. These include the ability to adjust the dose by small incremental steps within approved doses; set the dose in one step; adjust a bi-directional dose dial that allows dialed doses to be increased or decreased; confirm the dose delivered and, if necessary, the dose amount required from a second pen to complete the prescribed dose; and see the approximate amount of medication remaining in the pen through a graduated scale on the clear cartridge reservoir [6]. The pen is intended for subcutaneous self-injection and is available in three dosing preparations: 300, 450, and 900 IU. It has received the 2014 GOOD DESIGN Award for Design Excellence. The annual award program recognizes the most innovative and cutting-edge industrial, product, and graphic designs produced around the world.


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 redesigned follitropin alfa pen injection device.
© Copyright Policy - open-access
Related In: Results  -  Collection

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

Figure 0001: The redesigned follitropin alfa pen injection device.
Mentions: The redesigned follitropin alfa (r-hFSH) pen injector (GONAL-f®; pre-filled pen; Merck Serono, Geneva, Switzerland, a subsidiary of Merck KGaA, Darmstadt, Germany) was approved by the European Commission in May 2011 [4]. It was since approved by the US FDA in October 2013 (GONAL-f RFF® Redi-ject™; EMD Serono, Inc., Rockland, MA, USA, a subsidiary of Merck KGaA, Darmstadt, Germany) [5], and the pen has now been launched in 65 countries worldwide; in countries other than the USA, the pen is called GONAL-f Prefilled Pen. After attaching the needle and setting the dose, the redesigned pen (Figure 1) is a disposable, pre-filled, ready-to-use, pre-assembled pen that includes a number of feature modifications to the previous pen. These include the ability to adjust the dose by small incremental steps within approved doses; set the dose in one step; adjust a bi-directional dose dial that allows dialed doses to be increased or decreased; confirm the dose delivered and, if necessary, the dose amount required from a second pen to complete the prescribed dose; and see the approximate amount of medication remaining in the pen through a graduated scale on the clear cartridge reservoir [6]. The pen is intended for subcutaneous self-injection and is available in three dosing preparations: 300, 450, and 900 IU. It has received the 2014 GOOD DESIGN Award for Design Excellence. The annual award program recognizes the most innovative and cutting-edge industrial, product, and graphic designs produced around the world.

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