FDA alert issued for use of negative pressure wound therapy systems

The FDA released a preliminary public health notification regarding deaths and serious complications, specifically bleeding and infections, linked to the use of negative pressure wound therapy systems.

“Although rare, these complications can occur wherever NPWT systems are used, including acute and long-term healthcare facilities and at home,” Jeffrey E. Shuren, MD, JD, the acting director of the FDA’s Center for Devices and Radiological Health, wrote in the notification. “FDA has received reports of six deaths and 77 injuries associated with NPWT systems over the past two years.”

According to the notification, most of the reported deaths occurred in patients at home or in a long-term care center.

Bleeding occurred in six of the deaths and 17 injuries. Extensive bleeding was reported in patients with vascular grafts, those receiving anti-coagulant treatment, those with groin and sterna injuries; and during the removal of dressings that were attached to the tissues.

The FDA received 27 reports that pointed to infection resulting from the original open infected wounds or retained pieces of dressing within the wound. In addition, 32 injury reports listed remaining foam dressing pieces and foam in the wound.

In light of these events, the FDA recommends that health care practitioners carefully select patients for NPWT (negative pressure wound therapy), extensively consider patient risk factors before using the systems and be aware of wound types that are contraindicated for treatment with these systems.

The agency also advised that trained practitioners frequently monitor patients in appropriate care settings. Health care practitioners should take the patient’s wound status and location, condition and comorbidities into consideration when determining the frequency of monitoring.

“Be vigilant for potentially life-threatening complications, such as bleeding, and be prepared to take prompt action if they occur,” Shuren wrote.

In addition, health care practitioners should have adequate training before prescribing and using NPWT.

For patients using the systems at home, the FDA recommends that the patient and/or caregiver receive instruction on how to use the system, understand the potential complications, symptoms and warnings associated with use and know what to do if a problem occurs. Practitioners should also ask that the patient and/or caregiver to show that they know how to use the system, and this proficiency should be documented. If possible, practitioners should also give patients a copy of the patient labeling from the system manufacturer.

The agency also noted that practitioners should follow their facility’s reporting procedure when a reportable adverse event has occurred that is suspected to be associated with a NPWT system. In addition, the FDA encouraged practitioners to report adverse events linked to these systems that do not meet the requirements for mandatory reporting to the manufacturer or MedWatch.

Reference:
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm190658.htm