title: Medical technology at home: safety-related items in technical documentation.
abstract: OBJECTIVE
  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.
authors.affiliation: RIVM, Bilthoven, The Netherlands. ellen.hilbers@rivm.nl
authors.forename: Ellen S M
authors.initials: ES
authors.lastname: Hilbers
authors.forename: Claudette G J C A
authors.initials: CG
authors.lastname: de Vries
authors.forename: Robert E
authors.initials: RE
authors.lastname: Geertsma
mesh_terms: D003257:Consumer Product Safety; D006437:Hemodialysis, Home / Q000295:instrumentation*; D006699:Home Care Services; D006801:Humans; D007260:Infusion Pumps; D008370:Manuals as Topic; D009426:Netherlands; D061214:Patient Safety; D010530:Peritoneal Dialysis / Q000295:instrumentation*; D011358:Product Surveillance, Postmarketing; D011795:Surveys and Questionnaires; D012122:Ventilators, Mechanical