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• FDA: Negative pressure wound therapy - Use with care
• 12/01/2015
• 
           NEGATIVE Pressure wound therapy (NPWT) is used to treat acute and chronic wounds. A vacuum source creates continuous or intermittent negative pressure inside the wound to remove fluid, exudates, and infectious materials to prepare the wound for healing and closure.1 NPWT systems consist of a vacuum pump, drainage tubing, a foam or gauze wound dressing, and an adhesive film dressing that covers and seals the wound.
           Since 1997, when the first device indicated for NPWT was cleared by the FDA for marketing in the United States, the system has evolved considerably. New device and dressing features have been added that make the system safer, more efficient, and more user-friendly in care settings other than hospitals, such as in long-term care facilities, rehab centers, and even patients’ homes.
           Although many patients have benefited from NPWT, adverse events – including deaths and serious injuries – have been reported to the FDA. The following is a case example:
           An older adult underwent bilateral femoral endarterectomy for severe peripheral arterial disease. About 1 week after the procedure, the patient required surgery for wound exploration and evacuation of blood clots and then was diagnosed with an infection of the right groin incision. An NPWT system was applied to the wound and the patient was discharged home on antibiotic and coagulation therapy.
           Ten days later, the patient experienced a massive hemorrhage from the right groin wound. When paramedics arrived at the home, they provided basic life and advanced cardiovascular life support. After transport to the ED, the patient was pronounced dead. The cause of death was exsanguination.
  
           What went wrong?
           The most serious adverse events associated with NPWT, blood loss and infection, can be prevented if healthcare professionals pay close attention to:
           Device labeling, including warnings, instructions for use, indications, and contraindications.
           Criteria for patient selection, wound type, and appropriate care setting based on each patient’s needs.
  
           What precautions can you take?
           These strategies are recommended to prevent complications:
           Patient selection and wound type.
           Patients should be thoroughly evaluated for bleeding risk. The patient in the case example had several risk factors for bleeding, including history of postoperative blood clots in the wound, anticoagulation therapy, and wound infection. Besides being at high risk for infection, groin wounds are also prone to delayed wound closure due to hip joint movement.
           High-risk patients and selection of care setting.
           NPWT should be used in an appropriate healthcare setting based on the patient’s need for monitoring and wound care. At high risk for bleeding and infection, this patient should have been in a healthcare facility where healthcare professionals are available around the clock.
           Wound care-specific considerations.
           Many reported adverse events are the result of inappropriate methods of dressing change. For instance, bleeding can occur from improper removal of dressings that have adhered to or are imbedded in the tissues. Bleeding can also occur if the dressing is applied directly to exposed or superficial vessels in or around the wound that haven’t been completely covered and protected as recommended by the device manufacturer before initiating NPWT.
           Wound infections may develop if pieces of dressing are retained in the wound. To prevent this complication, device instructions recommend counting the total number of dressing pieces used in the wound and documenting that number on the outer adhesive film dressing and in the patient’s medical record. Teach the caregiver to count the number of dressing pieces removed to make sure that all pieces are accounted for.
           Training of healthcare providers, patients, and caregivers.
           Healthcare providers using NPWT devices should undergo appropriate training on device use, including its indications and contraindications, and recognition and management of potential complications.
           NPWT training for patients and their caregivers who will be using the device at home should include how to:
           - Safely operate the device; provide a copy of printed instructions for patient use from the specific device manufacturer
           - Respond to audio and visual alarms
           - Perform dressing changes
           - Recognize signs and symptoms of complications, such as redness, warmth, and pain associated with possible infection
           - Contact appropriate healthcare providers, especially in emergency situations
           - Respond to emergency situations; for instance, if bright red blood is seen in the tubing or canister, to immediately stop NPWT, apply direct manual pressure to the dressing, and activate emergency medical services.
           Use return demonstrations to evaluate patients’ and caregivers’ skills and comprehension of training materials.
           On November 13, 2009, the FDA published a preliminary public health notification on the use of NPWT systems. It will be updated according to findings of an ongoing investigation. Please review the links below for further details. You play an important role in keeping your patients safe when using NPWT.
  
           http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ ucm190658.htm
           http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PatientAlerts/ucm190476.htm
           http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm193277.htm
  
           REFERENCE
           1. Agency for Healthcare Research and Quality. Technology assessment: negative-pressure wound therapy devices. 2009.
           https://www.ecri.org/Documents/Press%20Releases/Negative_Pressure_Wound_Therapy_Devices.pdf disclaimer icon
           Although you need to support your healthcare facility’s adverse event-reporting policy, you may voluntarily report a medical device that doesn’t perform as intended by contacting MedWatch at 1-800-FDA-1088 (fax 1-800-FDA-0178) or online at http://www.fda.gov/Safety/MedWatch/HowToReport. Diane Dwyer, BSN, RN, who coordinates Device Safety, is a nurse consultant at the Center for Devices and Radiological Health at the FDA in Silver Spring, MD.
  
           By Nasrin Mirsaidi, MSN, RN, CNOR
           (Article reprinted from Nursing2010, September issue, p.64-66.)
           Nasrin Mirsaidi is a nurse consultant for general and plastic surgery devices at the Center for Devices and Radiological Health in Silver Spring, MD.
           http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm225038.htm