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• FDA: UPDATE on Serious Complications Associated with NPWT
• 24/02/2011
• 
  Audience:
  - Health Care Providers: Prescribing physicians and clinicians responsible for the ongoing care of patients whose wounds are being managed with negative pressure wound therapy (NPWT).
  - Patients and Caregivers
  
  Device:

  NPWT promotes healing in various types of open wounds by removing wound fluids and waste materials (debris) through the creation of a vacuum (negative pressure) at a well-sealed wound site. NPWT may also help with wound healing by drawing wound edges together.

  NPWT systems consist of the following parts: a pump that generates a vacuum and is capable of creating a negative pressure environment within a sealed wound; dressing materials used to pack the wound and seal it; tubing for fluid removal from the wound area; and a container/canister to collect waste materials that are removed from the wound area by suction.

  Purpose:

  On Nov. 13, 2009, the FDA issued a Preliminary Public Health Notification and Advice for Patients on serious complications, especially bleeding and infection, from the use of NPWT systems. Although rare, these complications can occur wherever NPWT systems are used, including hospitals, long-term health care facilities, and at home.

  The FDA is issuing this update to inform you about its activities to date involving NPWT, as well as to provide new recommendations and information about pediatric use. In addition, this communication provides a summary of additional reports received by the FDA since issuing the Preliminary Public Health Notification and Advice for Patients.

  
  Summary of Problem and Scope:

  Updated Death and Injury Reports to the FDA

  Since issuing the Nov. 13, 2009 Preliminary Public Health Notification and Advice for Patients, the FDA received reports of an additional 6 deaths and 97 injuries, for a total of 12 deaths and 174 injury reports since 2007. Sometimes increased public attention to FDA safety communications coincides with an increase in adverse event reporting.

  Three of the additional death reports indicated that the patients were receiving NPWT at home or in a nursing home. Also, in more than half of the additional injury reports that identified the location of care, adverse events occurred either at home or in a long-term care facility.

  Wound infection occurred in more than half of these additional cases, the majority of which were related to the retention of dressing pieces in the wounds. These patients experienced delayed recovery and required wound exploration, surgical removal of dead tissue (wound debridement), and drainage.

  Bleeding continues to be the cause of the most serious adverse events, and was reported in 12 patients, including three of the additional death reports. Bleeding occurred in patients who had blood vessel grafts, wound infection, those receiving medicine for blood clots, and during removal of dressings attached to the tissues. Bleeding contributed to shock, low blood pressure, and swelling containing blood (hematoma). Some of the patients who experienced bleeding required additional surgery to stop the bleeding, blood transfusions, admission to the emergency room and hospitalization.

  Previous Death and Injury Reports to the FDA

  The Nov. 13, 2009 Preliminary Pubic Health Notification and Advice for Patients indicated the FDA had received six death and 77 injury reports associated with NPWT devices since 2007. Most deaths occurred when the patients were at home or in a long-term care facility.

  Bleeding was the most serious complication, with reports of bleeding associated with each of the six deaths and with 77 injuries. Extensive bleeding occurred in patients with blood vessel grafts in the leg, breastbone and groin wounds, those receiving medication for blood clots, and during removal of wound dressings attached to the tissues. Patients with bleeding required emergency room visits and/or hospitalization and were treated with surgery and blood transfusions.

  Of these initial 83 reports to the FDA, 27 reports indicated worsening infection from original open infected wounds or from pieces of dressing that remained in the wound, and 32 reports noted injury from foam dressing pieces and foam sticking to tissues or clinging to the wound. Most of these patients required surgery, additional hospitalization, and antibiotics.

  FDA Activities:

  In order to learn more about NPWT safety issues, the FDA:

  • conducted reviews of published literature to obtain information about adverse events associated with outpatient use, and utilization and adverse events associated with pediatric use of NPWT.
  • completed a survey during 2009-2010 to obtain information about patient and health care provider experiences with NPWT that focused on issues that may occur in the home. To read an executive summary of the survey findings, see: Executive Summary of FDA Survey Findings.

  Findings from the literature review and survey support the FDA’s recommendations.

  The FDA will continue to monitor adverse events associated with NPWT systems, and will make available any new information that might affect their use.

  Pediatric Use:

  The safety and effectiveness of NPWT systems in newborns, infants and children has not been established at this time and currently, there are no NPWT systems cleared for use in these populations.

  Recommendations for Health Care Providers:
  • Select patients for NPWT carefully, after reviewing the most recent device labeling and instructions. Know that:
    • NPWT systems are contraindicated for certain wound types (Table 1), and
    • Patient risk factors (Table 2) must be thoroughly considered before use.
  • Assure that the patient is monitored frequently in an appropriate care setting by a trained practitioner. In determining the frequency of monitoring, consider the patient’s condition, including the wound status, wound location and co-morbidities. Ensure consistent wound care management by following the patient’s care plan.
  • Be vigilant for potentially life-threatening complications, such as bleeding, and be prepared to take prompt action if they occur.
  • Be aware of complications associated with dressing changes such as infection and bleeding, which can be associated with retained dressing pieces, adherence of new tissue to retained dressing pieces, or removal of tissue during dressing changes.
  • To help minimize the risk of retained dressing pieces:
    • Keep track of the number of dressing pieces placed in the wound.
    • Do not cut the dressing directly over the wound in order to avoid dressing fragments or debris falling into the wound area while cutting.
  • Obtain appropriate training about prescribing, using and discontinuing NPWT.
  • Resume NPWT as soon as possible after transitioning a patient to the home or another care facility so the wound stays moist.
  • If the patient is determined a proper candidate for using the NPWT system at home:
    - Instruct the patient and/or caregiver about how to use the system, potential complications and their signs/symptoms, and what to do if complications occur.
    - Request that the patient and/or caregiver demonstrate use of the system (such as familiarity with safety alarms), and document his/her proficiency.
    - Assure that the patient and/or caregiver understands the warnings associated with NPWT system use.
    - Provide the patient with a printed copy of the patient labeling from the NPWT system manufacturer, if available. Encourage the patient to keep these materials and instructions for use readily accessible.
    
  
  Recommendations for Patients and/or Their Caregivers:

  If your doctor has determined that you are a good candidate for using NPWT at home, you should:

  • Receive adequate training from your doctor, nurse, or home health care provider so that you understand how to use your NPWT device. Make sure you are familiar with the safety alarms for your NPWT device. Demonstrate to your trainer how to use NPWT to make sure you are doing it properly.
  • Understand the possible complications that may be associated with using your NPWT device. Watch especially for bleeding, such as bright red blood in the tubing or canister, which can be life-threatening. If you see signs of bleeding, seek medical assistance immediately.
  • Be aware that complications may occur during and after your dressing has been changed. These include infection and bleeding, which can happen if pieces of dressing remain in the wound, if new tissue sticks to retained pieces of dressing, or if tissue is removed during dressing changes.
  • Get NPWT patient instructions (labeling) from your doctor, home health care provider, NPWT distributor, or the manufacturer’s website. Keep these instructions where you can easily find them.
  • Talk to your doctor if you do not feel capable of managing the NPWT device at home. He or she might recommend that you have help from an appropriate caregiver.
  
  Questions for Patients and/or Their Caregivers to Ask Health Care Providers:

  Ask your health care provider about the risks and benefits of NPWT.

  Before transitioning from receiving NPWT in a health care facility to using it at home, consider asking the following questions:

  • Am I using the NPWT device correctly?
  • How long should I expect to use the NPWT device?
  • What serious complications might occur in my situation?
  • What should I do if any of those complications occur?
    - Whom do I contact?
    - How do I recognize bleeding?
    - How do I recognize serious infection?
    - How do I recognize if my wound condition is worsening?
    
  • Do I need to stop taking aspirin or any other medicines that affect my bleeding system or platelet function? What’s the risk associated with stopping or avoiding such medicines?
  • Can you provide me with patient instructions or tell me where I can find them?
  
  Reporting Problems to the FDA:

  Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. If you suspect a problem with a negative pressure wound therapy system, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Health care personnel employed by facilities that are subject to the FDA’s user facility reporting requirementsshould follow the reporting procedures established by their facilities.

  Please include the following information in your reports, if available:

  • Patient information (age, brief medical history including pre-existing conditions, type of wound)
  • Adverse event details (date adverse event occurred; type of adverse event, e.g. bleeding, infection; and the medical intervention required)
  • Wound therapy details (date started, type of dressing, frequency of dressing changes and by whom, vacuum setting)
  • Device name, model number and manufacturer
  • Adverse event location (e.g., hospital, long-term care facility, home)
  
  Contact Information:

  If you have questions about this communication, please contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at DSMICA@FDA.HHS.GOV, 800-638-2041 or 301-796-7100.

  Additional Information:

  For Health Care Providers

  • FDA Preliminary Public Health Notification: Serious Complications Associated with Negative Pressure Wound Therapy Systems
  • Negative Pressure Wound Therapy: Use with care (Article reprinted from Nursing 2010, September issue, p.64-66.)
  • Executive Summary of FDA Survey Findings

  For Patients and Caregivers

  • Advice for Patients: Serious Complications with Negative Pressure Wound Therapy Devices
  • FDA Consumer Update: Negative Pressure Wound Devices Draw FDA Notice, Advice

  For Health Care Providers:

  Table 1: NPWT is contraindicated for these wound types/conditions:

  necrotic tissue with eschar present untreated osteomyelitis non-enteric and unexplored fistulas malignancy in the wound exposed vasculature exposed nerves exposed anastomotic site exposed organs

   

  For Health Care Providers:

  Table 2: Patient risk factors/characteristics to consider before NPWT use:

  patients at high risk for bleeding and hemorrhage patients on anticoagulants or platelet aggregation inhibitors patients with: - friable vessels and infected blood vessels - vascular anastomosis - infected wounds - osteomyelitis - exposed organs, vessels, nerves, tendons, and ligaments - sharp edges in the wound (i.e. bone fragments) - spinal cord injury (stimulation of sympathetic nervous system) - enteric fistulas patients requiring: - MRI - Hyperbaric chamber - Defibrillation patient size and weight use near vagus nerve (bradycardia) circumferential dressing application mode of therapy- intermittent versus continuous negative pressure

  
  

  Special Study Summary 
  Survey Topic: Negative Pressure Wound Therapy (NPWT) 
  Year Conducted: 2009-2010
  Reference OMB No. 0910-0500
  

  Background

  The effort was to learn about device issues faced by professional home care providers, as well as those issues potentially encountered by lay caregivers who use NPWT in the home setting or in other non-hospital environments. While the FDA has received reports of problems with the use of NPWT, feedback from providers can help to promote a better understanding of why these adverse events occur and also inform FDA if other types of events have occurred.

  Participants were recruited from the Medical Product Safety Network (MedSun) facilities and from professional organizations that represent home care providers or advocate on behalf of wound care patients. Instruments included: a Web survey questionnaire; a semi-structured questionnaire for telephone interviews; and a self-administration questionnaire (SAQ). Three-hundred and forty two respondents completed the Web survey questionnaire, which ran for two months. Fifteen one-hour telephone interviews were conducted with seventeen participants using the semi-structured questionnaire; five participants completed the SAQ. Questions were based on the following topics: Device Performance and Experience, Prescription and Discharge Planning, Training and Labeling, Issues Associated with Dressings, Patient Outcome.

  Summary

  The most common NPWT systems used by respondents include the KCI Wound V.A.C.1 product line, mainly the ActiV.A.C. and V.A.C. Freedom2. Other commonly used systems were the Smith and Nephew (formerly Blue Sky) models.

  A model mentioned often by the phone/SAQ respondents was the ConvaTec Engenex. Phone /SAQ respondents were more likely to indicate complications, notably bleeding, infection, pain, retained foam and tissue adherence, whereas Web respondents primarily cited infection and bleeding issues.

  According to phone/SAQ respondents, prescription (patient selection, wound type, length of use), discharge planning and training tend to vary as a function of the facility type (hospital, outpatient clinic, Home Health Agency [HHA])3. These respondents felt that issues arise when there is a poor transition from the hospital to home and when the devices are not initially ordered, prescribed, set up or applied by a certified wound specialist or an experienced professional. Other problems were attributed to the prescriber’s lack of specific education about wound management therapy.

  Respondents indicated that lay caregivers and patients are largely trained on the meaning of alarms, how to troubleshoot, how to change drainage canisters, how to identify an emergency and what to do in an emergency situation. Respondents were generally happy with the lay-caregiver/patient educational materials, training and support provided by the manufacturer. Although most Web respondents thought all or some of these device labels and instructions were written for a lay audience, nearly two-thirds indicated they observed challenges with caregivers’ and patients’ ability to follow device instructions. Of those who observed challenges, the majority attributed them to patients’ or caregivers’ distractibility, whether because of their illness, altered consciousness, or other medical situation. A few phone/SAQ respondents suggested condensing the materials for the patient or to write them at a 5th or 6th grade reading level. Some had even written their own instructions to make them more understandable to the patient.

  Respondents stated patients or lay caregivers should not be administering the therapy because they aren’t trained to understand the complexities and intricacies of wound care, and also because clinical professionals are needed to monitor and assess the wound in addition to changing the dressing.

  Dressings were changed often, 2-3x per week, as indicated in the instructions. However, phone respondents stated that problems can arise when the dressing is changed too often, or not frequently enough.

  Overall, respondents felt that there is a definite benefit to NPWT therapy, regardless of the care setting and that it is a safe therapy when prescribed and administered appropriately. Safety and effectiveness in neonatal and pediatric patients has not been determined at this time, necessitating future study – a recommendation provided by phone respondents. Users generally are happy with the systems they use and the company support they and their patients receive.

  Respondents said there should be more prescriber education about when therapy can and should be used and, equally important, when it should be stopped. Some expressed the opinion that NPWT is overprescribed mainly because of aggressive marketing tactics. Phone/SAQ respondents, especially directors of wound care centers, said that home care providers need to be more experienced when it comes to administering wound care and changing dressings. Opportunities to gain more experience and expertise should be afforded to those who provide care. They also felt there needs to be more consistent patient and wound monitoring, especially in the home setting.

  Special Studies and Surveys are two of many tools the Agency is using to evaluate the public health impact of the potential problems associated with the use of medical devices. Additionally, FDA continues to receive adverse event reports from its Medical Device Reporting program. FDA will also continue to make use of the literature and other published information. FDA scientific, medical, nursing and engineering staff are made aware of the survey results as needed. If FDA believes there is a significant risk of adverse events as noted from the survey, it will combine those results with data gained from the other sources. FDA will work with the manufacturers and health care professional organizations to make important information known to the clinical community. Additionally, FDA continues to work with manufacturers to ensure the development, testing and promulgation of methods for reducing the risk associated with these devices and to minimize the complications from adverse events that may occur in the course of normal usage. If the results of any survey raise serious concerns about the safety of these devices, FDA may convene an Ad Hoc group of clinical and manufacturing representatives to discuss further actions.

  1 Vacuum Assisted Closure (V.A.C.)

  2 Note: of all the respondents surveyed, KCI was the most common system used and is why majority of the findings refer to this particular manufacturer’s product line.

  3 Web respondents were not asked about discharge planning because respondents are primarily home care providers, who provide patient care regardless of how the therapy migrates into the home. 

  This document reflects the FDA’s current analysis of available information, in keeping with our commitment to inform the public about ongoing safety reviews of medical devices.

  
  Reference:
  http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm244211.htm