PMID- 30100197
OWN - NLM
STAT- MEDLINE
DCOM- 20191118
LR  - 20191118
IS  - 1934-8150 (Electronic)
IS  - 1551-7411 (Linking)
VI  - 15
IP  - 5
DP  - 2019 May
TI  - Consumer opinions on adverse events associated with medical devices.
PG  - 568-574
LID - S1551-7411(18)30134-7 [pii]
LID - 10.1016/j.sapharm.2018.07.015 [doi]
AB  - INTRODUCTION: Post-market surveillance of medical devices relies on compulsory 
      and voluntary reports. Although direct consumer reporting of medical 
      device-related adverse events (AEs) is available in Australia, the proportion of 
      consumer reports has remained low. Limited qualitative research has previously 
      explored consumer insights on AEs associated with medical devices and in 
      particular, AE reporting. OBJECTIVE: To explore consumer opinions on AEs related 
      to medical devices, and their knowledge of, experiences with, and views on, the 
      reporting of medical device-related AEs. METHODS: Focus groups (n = 4; total of 
      29 participants) were conducted in metropolitan Sydney, Australia. Focus group 
      discussions of approximately 1.5 h in length centred on consumers' understanding 
      of AEs, opinions on AEs and their previous experiences, views on medical device 
      benefits and harms, and actions taken (or potential actions) in response to AEs. 
      With participant consent, discussions were audio-recorded, transcribed verbatim, 
      and thematically analysed. RESULTS: Participants regarded medical device-related 
      side effects to be unexpected AEs associated with their use. Where there was a 
      clear need for the medical device itself, potential improvement in quality of 
      life took precedence over potential harms. Most participants had not experienced 
      negative issues with their medical device(s). There was poor awareness among 
      participants of an existing direct consumer AE reporting system for medical 
      devices. Despite this, the value of reporting was acknowledged. Severity of the 
      AE was a key motivator for potential AE reporting. CONCLUSIONS: Further efforts 
      are necessary to improve consumer awareness of available AE reporting systems to 
      better support post-market surveillance and safe medical device use.
CI  - Copyright (c) 2018 Elsevier Inc. All rights reserved.
FAU - Aslani, Parisa
AU  - Aslani P
AD  - Faculty of Pharmacy, Pharmacy and Bank Building A15, The University of Sydney, 
      Science Road, Broadway, NSW, 2006, Australia. Electronic address: 
      parisa.aslani@sydney.edu.au.
FAU - Hamrosi, Kim
AU  - Hamrosi K
AD  - Faculty of Pharmacy, Pharmacy and Bank Building A15, The University of Sydney, 
      Science Road, Broadway, NSW, 2006, Australia.
FAU - Tong, Vivien
AU  - Tong V
AD  - Faculty of Pharmacy, Pharmacy and Bank Building A15, The University of Sydney, 
      Science Road, Broadway, NSW, 2006, Australia.
FAU - Chen, Timothy F
AU  - Chen TF
AD  - Faculty of Pharmacy, Pharmacy and Bank Building A15, The University of Sydney, 
      Science Road, Broadway, NSW, 2006, Australia.
FAU - Cook, Jane
AU  - Cook J
AD  - Therapeutic Goods Administration, Canberra, Australia.
FAU - Fois, Romano
AU  - Fois R
AD  - Faculty of Pharmacy, Pharmacy and Bank Building A15, The University of Sydney, 
      Science Road, Broadway, NSW, 2006, Australia.
FAU - McGarry, Theresa
AU  - McGarry T
AD  - Celgene Pty Ltd, 15/60 City Road, Southbank, Victoria, 3006, Australia.
FAU - Moore, Carter
AU  - Moore C
AD  - Consumers Health Forum of Australia, Canberra, Australia.
FAU - Peters, Rodney
AU  - Peters R
AD  - Pharmacovigilant Consultant, Sydney, Australia.
FAU - Spagnardi, Sarah
AU  - Spagnardi S
AD  - NPS MedicineWise, NSW, Australia.
FAU - Whitelock, Karen
AU  - Whitelock K
AD  - Novartis Pharmaceuticals Australia Pty Ltd., 54 Waterloo Rd, Macquarie Park, NSW, 
      2113, Australia.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20180721
PL  - United States
TA  - Res Social Adm Pharm
JT  - Research in social & administrative pharmacy : RSAP
JID - 101231974
SB  - IM
MH  - Adult
MH  - Aged
MH  - Attitude
MH  - Australia
MH  - Community Participation
MH  - Equipment and Supplies/*adverse effects
MH  - Female
MH  - Focus Groups
MH  - Health Knowledge, Attitudes, Practice
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - *Product Surveillance, Postmarketing
OTO - NOTNLM
OT  - Adverse events
OT  - Consumer
OT  - Focus groups
OT  - Medical devices
OT  - Qualitative
OT  - Side effects
EDAT- 2018/08/14 06:00
MHDA- 2019/11/19 06:00
CRDT- 2018/08/14 06:00
PHST- 2018/02/27 00:00 [received]
PHST- 2018/07/02 00:00 [revised]
PHST- 2018/07/20 00:00 [accepted]
PHST- 2018/08/14 06:00 [pubmed]
PHST- 2019/11/19 06:00 [medline]
PHST- 2018/08/14 06:00 [entrez]
AID - S1551-7411(18)30134-7 [pii]
AID - 10.1016/j.sapharm.2018.07.015 [doi]
PST - ppublish
SO  - Res Social Adm Pharm. 2019 May;15(5):568-574. doi: 10.1016/j.sapharm.2018.07.015. 
      Epub 2018 Jul 21.