title: Human factors engineering and design validation for the redesigned follitropin alfa pen injection device.
abstract: OBJECTIVE
  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.
authors.affiliation: EMD Serono, Inc. , One Technology Place, Rockland, MA 02370 , USA +1 781 681 2438 ; +1 781 681 2900 ; mary.mahony@emdserono.com.
authors.forename: Mary C
authors.initials: MC
authors.lastname: Mahony
authors.forename: Patricia
authors.initials: P
authors.lastname: Patterson
authors.forename: Brooke
authors.initials: B
authors.lastname: Hayward
authors.forename: Robert
authors.initials: R
authors.lastname: North
authors.forename: Dawne
authors.initials: D
authors.lastname: Green
mesh_terms: D000328:Adult; D004867:Equipment Design; D006804:Ergonomics; D005260:Female; D043373:Follicle Stimulating Hormone, Human / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007267:Injections / Q000295:instrumentation; D008875:Middle Aged; D009726:Nurses; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects; D055815:Young Adult
chemical_list: D043373:Follicle Stimulating Hormone, Human; D011994:Recombinant Proteins; C571801:follitropin alfa
keywords: failure modes and effects analysis; follitropin alfa pen; human factors engineering; usability; validation testing