Developing A Policy Based On Your Needs

  “There is no greater thing than standing victorious in the arena. You have earned a glorious death, and shall die at the hands of a gladiator.” -Crixus, Sparticus

  I spent the better part of last week working with the Alliance of Wound Care Stakeholders™ on supplier quality standards for negative pressure devices (NPWT) in anticipation of competitive bidding. Although competitive bidding is a laudable idea, I doubt that it is going to control costs without compromising the quality of care for our patients. A better methodology is needed to maintain clinical excellence in an affordable fashion.

  In recent years, cinema directors have revived the glory and gore of ancient gladiatorial combat. I must admit that I am captivated by the Showtime® series, Spartacus and I thoroughly enjoyed Russell Crowe’s performance in The Gladiator. On occasion it is prudent and profitable to revisit the distant past.

  A scene out of medicus mundi troubles my sight.

  I wonder how the very practical Romans would have addressed the NPWT issue?

  Trumpets blare. All of the NPWT devices parade into the Coliseum.

  The Coliseum in this case is one of the Gaylord Hotel “biodomes,” that will serve as the setting for our spectacle. The event begins in the grand exhibit hall. The competitors are on display attended to by comely sales representatives. Let the games begin. There is no need for something as complicated and esoteric as competitive bidding: The various NPWT devices fight to the death in gladiatorial fashion until the victor is crowned “succus maximus.” The collected AAWC and WHS board members adorned in togas and olive branches sit in judgment of the event (The general attendees will also be in toga dress, but they will have fewer stickers on their badges). A defeated device is given thumbs down and hanged by its tubing until all alarms fall silent. The pumps fortunate enough to receive a thumbs-up are allowed to crawl off the stage vanquished, but still able to provide a low cost option to the unfortunates not regulated by competitive bidding. The victor will reign until the next year when a new crop of inventors and manufacturers rises from the ashes to scrap for a share of the billion-dollar market.

  Short of a head-to-head death match, it is likely that regulatory agencies or other governing bodies will determine the NPWT systems available to our patients. Is the wound care community responsible for this development? We must share the blame. We have not been good stewards of this essential technology—Certainly, one cannot expect manufacturers to police the use of their own products. Yet the unbridled use of negative pressure puts the legitimate use of this product in jeopardy. We must intervene or allow non-woundologists to dictate the medical care we provide.

  I first became aware of the problem with NPWT at a meeting with one of our hospitals. I wanted to procure a diagnostic device for the outpatient wound clinic. The chief medical officer quipped that he would be glad to purchase it if I could control the use of NPWT on inpatients. NPWT, he added in a more serious tone, was an enormous financial burden for the hospital. To his surprise, I accepted the challenge.

  My team reviewed the inpatient use of NPWT. First, we found a large percentage of patients received NPWT only during their hospital stay averaging 3-5 days. For a variety of reasons the therapy was not continued at discharge. There were also numerous cases of inappropriate use; including patients without wounds (There is inadequate evidence to support the use of NPWT on incisions at this time). Moreover, I found many of the physicians ordering NPWT had little if any knowledge of the device. Most of the NPWT care was provided by nursing staff that wrote verbal orders for the physician to countersign. The hospital had no credentialing process in place for the devices and there was no informed consent process despite the fact that there have been serious adverse events including deaths related to NPWT use. Finally, the home health nurses complained about the operative placement of the NPWT dressing. The home health director had serious concerns about repeated episodes of retained dressings in the acute wounds they were treating post discharge. In most of these cases the NPWT device had been placed and the patient discharged within 48 hours.

  We put together a team including the wound care medical director; the inpatient wound care nurses and an administrative representative. Over the next several months we developed a policy for inpatient NPWT use. I have summarized the key elements of this particular policy in the bullet points below. However, it should be stressed that each hospital needs to develop an individual policy based on their particular needs.

  • NPWT could only be ordered with a wound care consult. The patient was seen by a physician or WOCN experienced with NPWT. The medical director and physician staff of the outpatient wound clinic provided inpatient coverage as part of the wound care team.

  • The wound clinic medical director reviewed requests for exceptions to the policy.

  • NPWT use was limited to patients with wounds. Until there is sufficient evidence for the use of NPWT on incisions in the form of a randomized controlled clinical trial or similar investigation (e.g. registry) demonstrating efficacy, its use was restricted to open wounds.

  • NPWT devices were not to be placed intra-operatively if the patient was expected to have a hospital stay less than 3-5 days. This policy was instituted as a safety measure.

  • NPWT was not applied to patients whose hospital stay was anticipated to be less than 5 days. There was insufficient evidence to support short term inpatient use. Moreover, there were concerns about the use of the device when the patient changed care settings (There are new single use devices that may permit modification of the policy in the future).

  • If NPWT was considered a treatment option for an inpatient the appropriate outpatient organization (e.g. wound clinic, home health) was contacted early during the hospital stay to arrange for the service at discharge.

  • Physicians ordering NPWT had to be credentialed in NPWT. This policy has not been adopted because there is no official credentialing process for physicians as yet. I applaud the efforts of Kinetic Concepts Inc. in credentialing clinicians. This is a good first step. However, this credentialing should not be product specific and should not be provided by industry.

  The overall purpose of this process was to develop a protocol to treat the wounds that were most likely to benefit from NPWT, reduce adverse events, control access by requiring consultation with clinicians trained and certified in NPWT, and to utilize NPWT in a fiscally responsible fashion. Interestingly, the policy was embraced by the wound clinic, surgery department and medical staff. There has been a precipitous fall in inpatient NPWT. Preliminary results suggest significant savings without compromising patient care.

  The interventions described are only one example of a solution to the inpatient NPWT problem facing our hospitals. Let me suggest that each hospital evaluate its current utilization patterns and then develop policies, which are sensible for their situation. Finally, a broad initiative such as a device registry would provide the data necessary to make more informed decisions on NPWT use.

  Dr. Thomas E. Serena MD FACS FACHM FAPWCA, Founder and Medical Director of The Serena Group™, a family of wound, hyperbaric and research companies, is a Phi Beta Kappa graduate of The College of William and Mary and Penn State Medical School. He completed his residency in Surgery at The Milton S. Hershey Medical Center with fellowship training in Plastic and Reconstructive Surgery at Southern Illinois University.

  To date he has opened and operates wound care centers from New York City to Tulsa Oklahoma. Dr. Serena has been the lead or Principal investigator in over 55 clinical trials, including testing blood platelets, gene therapy for critical limb ischemia, antimicrobial dressings, growth factors, topical and parenteral antibiotics and bi-layered cell therapy. He currently consults for the government of Rwanda on AIDS prevention research.

  He has 100 published papers and has given more than 200 invited lectures throughout the world. He has been a member of the Board of Directors of the Wound Healing Society and recently was an author on four of the national guidelines for the treatment of chronic wounds. In 2009 he was elected Vice-President of the American College of Hyperbaric Medicine. He also currently serves on the board for the Association for the Advancement of Wound Care. Recently, Dr. Serena returned from Haiti where he was the wound care team leader for the University of Miami’s Medishare Hospital. He has done extensive medical relief work with Health Volunteers Overseas and serves as chairman of the AAWC Global Volunteers/HVO Steering Committee.