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Updated: May 10, 2026
Development of a Benchtop Model for Evaluating the Compatibility of Wound Dressing Materials with Negative Pressure Wound Therapy Systems
Published on: May 2, 2025
Provider experiences with negative-pressure wound therapy systems
Diana Kaufman-Rivi1, Antoinette C Hazlett, Mary Anne Hardy
1Food and Drug Administration Center for Devices and Radiological Health, Office of Surveillance and Biometrics, Division of Patient Safety Partnerships, Silver Spring, MD, USA.
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.
Participants:
The FDA surveyed wound care specialists and professional home healthcare providers to learn about users' experiences with NPWT.
Design:
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.
Conclusion:
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.
Insights
Negative-pressure wound therapy (NPWT) is beneficial and safe when used correctly. However, challenges in NPWT prescription, training, and patient monitoring require attention for optimal outcomes in home and facility settings.
Area of Science:
- Medical Devices
- Wound Care
- Healthcare Technology
Background:
- The Food and Drug Administration's (FDA) MedWatch system monitors adverse events for medical devices post-market.
- Negative-pressure wound therapy (NPWT) systems are increasingly used in home and extended-care settings.
- Reports of deaths and serious injuries associated with NPWT prompted further investigation.
Purpose of the Study:
- To investigate device issues faced by healthcare professionals with NPWT.
- To explore challenges faced by caregivers using NPWT at home.
- To gather insights into user experiences with NPWT in various care environments.
Main Methods:
- An exploratory and descriptive study design was employed.
- A semistructured questionnaire was developed for telephone interviews and self-administration.
- A web-based survey was adapted from the initial questionnaire for broader reach.
Main Results:
- Concerns focused on NPWT prescription, provider education, and patient training.
- Appropriate wound management practices, including ongoing assessment and monitoring, were highlighted.
- Issues were primarily related to the application and management of NPWT, not the devices themselves.
Conclusions:
- Respondents perceived NPWT as a therapy with definite benefits across care settings.
- NPWT was considered safe when appropriately prescribed and administered.
- Improvements in NPWT prescription, education, and patient monitoring are recommended.
