My Scope of Practice: Getting Patients the Support They Need

   Victoria Langer, CNA, STNA (and in pursuit of her RN degree and certification as a Wound Care Specialist) is an expert at making lemonade from lemons. Several years ago, while she was working at an eye surgery center, her husband Larry developed an aggressive form of thyroid cancer.

Larry's condition deteriorated very rapidly - 13 tumors had metastasized to his spinal cord and lungs. Following a tracheostomy, Larry needed a device that would elevate and position him more comfortably, but the foam wedges available in their hometown of Mansfield, Ohio caused too much additional pressure. Victoria purchased an interesting piece of foam that she wrapped around towels and secured with quilter's thread, creating what looked like a porcupine. Larry took this effective positioning/supportive device with him when he was hospitalized. The staff applauded its functionality and requested that Victoria make more. Distraught over Larry's death and preoccupied with raising two teenage sons, she couldn't immediately face that task. Eventually, heeding the words of her husband, who said, "Sweetie, do something with this product. It helps people," Victoria gathered the strength to answer the demand for her innovation.

   Now Victoria is President of Global Medical Foam, Inc., a manufacturer and patent holder of several different positioning/supportive devices. She oversees development, production, and sales of numerous pressure management products. "After Larry's death, I took a job in a surgical control center while attending nursing school," Victoria shares. "I experimented with a few prototypes for the hospital and general medical marketplace - sewing at home, making a few design changes on the covers and material, and adapting the device to suit the situation. In the beginning, I was using plumber's glue on the original prototypes to hold the devices together."

   At the request of nurses and physicians, Victoria reconstructed the original, working with the physicians and surgeons to develop a heel device. This new product allowed the heels to float just enough off the bed to slide a piece of paper under (to provide true pressure relief), with pressure reduction well below the 34 mm Hg necessary to provide good capillary refill time. With the knowledge and skills she had learned, she knew that with too high a toe elevation, extremities could be compromised and subsequently amputated.

   Victoria eventually went back to the local foam company and asked if a product could be created from her prototype. From there, she got a crash course in Design and Utility patents, along with packaging, labeling, shipping, and SKU numbers. She became well versed in monolithic (fluid-proof) covers (she demanded that her covers be thin, nonslip, antibacterial, antifungal, and highly washable) and learned about DMERCS, SADMERCS, and the trials of PPS. Meanwhile, she went back into the OR to stay in touch with what was happening. "Many pressure ulcers begin in the OR," she notes. "For instance, staff do not float the patients heels during lengthy surgeries."

   She provided her devices to the local hospital and long-term care facilities, working the hospital day shift from 6:00 a.m. to 2:30 p.m. and scheduling sales calls for 3:30 p.m. and beyond. When orders for her devices started to grow, she tried flipping her schedule around to accommodate her clinical and sales responsibilities until 3 years ago when she decided to devote herself to sales and business decisions full time. Her patent attorney offered the incentive: "There is nothing else like this out there."

   Victoria realized that she wasn't only selling a product, but also a plan of care. "Continuing education is key," Victoria says. She conducts continuing education programs on pressure ulcer prevention, using familiar, real-life scenarios as teaching tools. These sessions contain refresher courses on the basic tenets of basic pressure ulcer care and prevention, including positioning, transferring, information on the severity of suffering, and data on the costs incurred without proper attention to positioning and support. She recently obtained her Ohio Nurses Association certification to be able to provide CEUs for RNs and LPNs. Her presentation, "Pressure Ulcers: Avoidable or Unavoidable," stresses how staff, with much emphasis on teamwork, can make a difference; it has been laughingly subtitled, "Save Your Butt." Victoria currently is seeking a grant to produce a continuing education video for caregivers on the importance of determining the difference between pressure relief and pressure reduction and the value of proper positioning. She is aware, for example, that when caregivers observe a reddened area on a resident/patient or loved one, they often have no idea they are looking at erythema (a Stage I pressure ulcer).

   Victoria says her passion is people. She feels a special affinity to those in long-term care, especially the elderly, and she is an advocate of "hugs, pats, and repositioning every 15 minutes." She is sometimes stymied by Medicare-approved reimbursement rates and hopes to see policy changed to include more emphasis on prevention. Through the benefits of being a member of the Ohio Health Care Association, she is able to stay current on the legislative issues and challenges that administrators and Directors of Nursing face daily. She frequently invites State Senators and legislative staff to her continuing education sessions to learn about wound care to better comprehend how legislation can influence reimbursement regarding pressure ulcer prevention.

   Improvements and innovations to Victoria's products are ongoing, all a result of her observations of needs that arise in the course of care. Her products are designed to adhere to AHRQ guidelines and protocols set forth by JCAHO. They are all EPA certified and latex-free. Her market has expanded from hospitals and long-term care centers to include wound care centers, burn units, rehabilitation and palliative care facilities, hospices, home health providers, diabetic centers, lymphedema clinics, Alzheimer's units, kidney centers, and state developmental centers.

   Taking a product from "birth" through patenting, manufacturing, and marketing is a task that requires many 16+ hour days and lots of decisions. "Like anything else, you need to know a great deal about all the processes, from manufacturing to marketing to financing," Victoria says. "You need to have a good rapport with your contacts and be willing to rise to the challenges. Manufacturers, for example, can move out of state, not be able to meet the demand, or not have the correct material. In our business, this would be devastating, because we know that facilities need their wound care products yesterday."

   Meanwhile, the need for her compassion and ingenuity continue to touch sadly close to home. Her father was bedbound and on a ventilator for 5 months before his death in the summer of 2001 and her mother has been chronically ill for some time and requires a wheelchair. Both benefitted from Victoria's ability to make them, literally, more comfortable.

   Presently, Victoria is working with two nurses who have developed products. They are about to have first prototypes produced. She enjoys passing on whatever knowledge she has gained. She is grateful for the encouragement she received from Kelly DiPoalo, RN, who many years ago put her in touch with a patent attorney, and to Richard Clark, BA, MD, FACS, FRCS(C), her mentor in wound care. Bruce Gibbons, PhD, a developer and patent holder of many wound care products, is currently helping her write a grant to secure grant dollars for another innovative project. She appreciates Ray Mong, business owner, and the many supportive business people in her home town whose brains she "has picked completely." She is also thankful for a company Board of Directors willing to offer sound advice and Karen Banks, her administrative assistant, whose knowledge has grown along with her own. "Everywhere I have gone, people have been so free to offer thoughts and ideas and even warnings when necessary." Victoria is glad to be in a position to be able to pay forward the favor, sharing the wisdom of experience with others who are inspired to create care and prevention solutions as part of their scope of practice.

   My Scope of Practice is made possible through the support of ConvaTec, A Bristol-Myers Squibb Company, Princeton, NJ.