.
Date: Mon, 16 Nov 2009 18:51:42 -0600
From: "Barbara Acello, RN" <[log in to unmask]>
Reply-To: [log in to unmask]
To: [log in to unmask]
Subject: [Net-Gold] Negative Pressure Wound Therapy (NPWT) Systems - Preliminary
Public Health Notification
.
Negative Pressure Wound Therapy (NPWT) Systems -
Preliminary Public Health Notification
[Posted 11/16/2009]
FDA notified healthcare professionals
of a Preliminary Public Health
Notification describing deaths and
serious complications associated with
the use of Negative Pressure Wound
Therapy (NPWT) systems.
FDA has received reports of six deaths
and 77 injuries associated with
NPWT systems over the past two years.
NPWT systems are generally indicated for
the management of wounds, burns, ulcers,
flaps and grafts. They apply negative
pressure to the wound in order to remove
fluids, including wound exudates,
irrigation fluids, and infectious
materials. Healthcare professionals were
advised to select patients for NPWT
carefully, after reviewing the most recent
device labeling and instructions. Patients
should be monitored frequently in an
appropriate care setting by a trained
practitioner, and practitioners
should be vigilant for potentially
life-threatening complications, such as
bleeding, and be prepared to take prompt
action if they occur.
Read the MedWatch safety summary, including
links to the FDA Preliminary Public Health
Notification and FDA Advice to Patients, at:
<http://tinyurl.com/ylsaue4>
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