title: Provider experiences with negative-pressure wound therapy systems.
abstract: OBJECTIVE
  MedWatch, the Food and Drug Administration's (FDA's) nationwide adverse event reporting system, serves to monitor device performance after a medical device is approved or cleared for market. Through the MedWatch adverse event reporting system, the FDA receives Medical Device Reports of deaths and serious injuries with negative-pressure wound therapy (NPWT) systems, many of which are used in homes and in extended-care facilities. In response to reported events, this study was conducted to obtain additional information about device issues that healthcare professionals face in these settings, as well as challenges that caregivers might encounter using this technology at home. The study was exploratory and descriptive in nature.
  
  
  METHODS
  The FDA surveyed wound care specialists and professional home healthcare providers to learn about users' experiences with NPWT.
  
  
  METHODS
  In the first phase of the study, a semistructured questionnaire was developed for telephone interviews and self-administration. In the second phase, a web-based survey was adapted from the semistructured instrument.
  
  
  RESULTS
  Respondent concerns primarily centered on issues not directly related to the NPWT devices: NPWT prescription, provider education in addition to patient training and appropriate wound management practices, notably ongoing wound assessment, and patient monitoring.
  
  
  CONCLUSIONS
  Overall, respondents thought that there was a definite benefit to NPWT, regardless of the care setting, and that it was a safe therapy when prescribed and administered appropriately.
authors.affiliation: Food and Drug Administration Center for Devices and Radiological Health, Office of Surveillance and Biometrics, Division of Patient Safety Partnerships, Silver Spring, MD, USA.
authors.forename: Diana
authors.initials: D
authors.lastname: Kaufman-Rivi
authors.forename: Antoinette C
authors.initials: AC
authors.lastname: Hazlett
authors.forename: Mary Anne
authors.initials: MA
authors.lastname: Hardy
authors.forename: Jacquelyn M
authors.initials: JM
authors.lastname: Smith
authors.forename: Heather B
authors.initials: HB
authors.lastname: Seid
mesh_terms: D000328:Adult; D004867:Equipment Design; D004869:Equipment Safety; D005260:Female; D019538:Health Care Surveys; D006282:Health Personnel; D006699:Home Care Services; D006801:Humans; D008297:Male; D054843:Negative-Pressure Wound Therapy / Q000295:instrumentation* / Q000379:methods; D010348:Patient Care Team / Q000458:organization & administration; D011786:Quality Control; D011795:Surveys and Questionnaires; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards; D014947:Wounds and Injuries / Q000175:diagnosis / Q000628:therapy*