scholarly journals Using Post-market Surveillance to Assess Safety-relevant Events in a Digital Rehabilitation Application (Kaia App): Results from an Observational Study (Preprint)

10.2196/25453 ◽  
2020 ◽  
Author(s):  
Deeptee Jain ◽  
Kevin Norman ◽  
Zac Werner ◽  
Bar Nachmani ◽  
Turner Baker ◽  
...  
Keyword(s):  
Observational Study ◽  
Market Surveillance ◽  
Post Market Surveillance ◽  
Post Market

WallstentR esophageal prosthesis: Post-market surveillance study

1996 ◽  
Vol 43 (4) ◽  
pp. 339 ◽  
Author(s):  
J. Lavergne ◽  
K. Fields ◽  
J.S. Barkin ◽  
D.L. Carr-Locke ◽  
R.A. Kozarek ◽  
...  
Keyword(s):  
Surveillance Study ◽  
Market Surveillance ◽  
Post Market Surveillance ◽  
Post Market ◽  
Esophageal Prosthesis

scholarly journals MEDICAL TECHNOLOGY AT HOME: SAFETY-RELATED ITEMS IN TECHNICAL DOCUMENTATION

2013 ◽  
Vol 29 (1) ◽  
pp. 20-26 ◽  
Author(s):  
Ellen S.M. Hilbers ◽  
Claudette G.J.C.A de Vries ◽  
Robert E. Geertsma
Keyword(s):  
Risk Analysis ◽  
Medical Equipment ◽  
Field Experiences ◽  
Technical Documentation ◽  
Infusion Pumps ◽  
Home Setting ◽  
Market Surveillance ◽  
Post Market Surveillance ◽  
Post Market ◽  
At Home

Objectives: This study aimed to investigate the technical documentation of manufacturers on issues of safe use of their device in a home setting.Methods: Three categories of equipment were selected: infusion pumps, ventilators, and dialysis systems. Risk analyses, instructions for use, labels, and post market surveillance procedures were requested from manufacturers. Additionally, they were asked to fill out a questionnaire on collection of field experience, on incidents, and training activities.Results: Specific risks of device operation by lay users in a home setting were incompletely addressed in the risk analyses. A substantial number of user manuals were designed for professionals, rather than for patients or lay carers. Risk analyses and user information often showed incomplete coherence. Post market surveillance was mainly based on passive collection of field experiences.Conclusions: Manufacturers of infusion pumps, ventilators, and dialysis systems pay insufficient attention to the specific risks of use by lay persons in home settings. It is expected that this conclusion is also applicable for other medical equipment for treatment at home. Manufacturers of medical equipment for home use should pay more attention to use errors, lay use and home-specific risks in design, risk analysis, and user information. Field experiences should be collected more actively. Coherence between risk analysis and user information should be improved. Notified bodies should address these aspects in their assessment. User manuals issued by institutions supervising a specific home therapy should be drawn up in consultation with the manufacturer.

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