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Patricia learned quickly that David not only wanted to get his valve manufactured and marketed, he wanted to be a part of the process. Thus began their journey establishing the company, obtaining FDA clearance, applying for patents, working with engineers to develop the manufacturing process and developing clinical studies. David and Patricia advertised in national medical journals and attended national speech pathology, pulmonology, otolaryngology and respiratory meetings. David was quite the celebrity at these meetings and was always very busy at the exhibit booth discussing the advantages of the Passy-Muir Valves with physicians and clinicians. David loved being able to personally interact with the individuals prescribing and using his valve and David was admired and respected by the professionals and patients fortunate enough to meet him. David took valve orders over the phone and did the invoicing with his voice operated computer. He and his mother, June, also provided "clinical" information on his valve to patients, families and healthcare professionals.
David passed away in August of 1990 and he is missed daily. Those of us who were fortunate enough to have known David can remember his powerful presence, gracious smile and lively humor. David's spirit, intelligence, innovation, determination and commitment are a part of every Passy-Muir Valve product produced. We are always conscious of David's mission in everything we do at Passy-Muir. He is the reason we have the opportunity to give the gift of speech to patients and it is David's vision of making his valve available to every patient with the potential to speak that drives our commitment and inspires our work. We are continually impressed by the patients' and clinicians' knowledge of David's contribution and their loyalty to his mission and his valves. Read David's Story
The Medical Environment
When the company was started in 1985, there was virtually no education offered on communication options for tracheostomized and ventilator dependent patients. Effective options for speech did not exist and finger occlusion was the standard of care for tracheostomized patients. If patients did not have use of their hands or if they were ventilator dependent, it was accepted medical practice that such patients simply did not speak. Pediatric tracheostomy patients were taught sign language as their most viable means of communication. At this point in time, some of the effects of a tracheostomy on the anatomy and physiology of a patient had not even been identified. Disrupted swallowing function, olfaction, appetite, weight loss and excess secretions are serious complications of a tracheostomy that had been overlooked or inadequately addressed by the medical community for years.
David's valve had a significant impact on the role of speech-language pathologists and respiratory therapists in providing communication and swallowing therapy for tracheostomy and ventilator dependent patients. Prior to the Passy-Muir Valve, respiratory therapists were primarily consulted for airway management and monitoring of patients' ventilator systems without having any effective means available to communicate with their patients. Education on communication issues for the patient population was not offered. Course textbooks, curriculum and entire clinical programs lacked education regarding the specific needs of these patients and their need to communicate. Educational seminars on communication for tracheostomized and ventilator dependent patients did not exist and almost no research was published on the topic. Until David made his valve available, there was little awareness of the tragic and unnecessary silence of this entire patient population.
Advancements in Tracheostomized and Ventilator Dependent Patient Care
Since the introduction of David's valve, new opportunities for patients and professionals have emerged. Speech-language pathologists and respiratory therapists are now leading interdisciplinary teams of clinicians from pulmonology, otolaryngology, nursing, rehabilitation and occupational therapy departments. These diverse team members work together to assess, recommend and carry-out treatment interventions for tracheostomized and ventilator dependent patients. The Passy-Muir Valve facilitates this interaction, creating a dynamic and comprehensive approach to patient care that increases the effectiveness of the clinicians and the healing of the patient. For speech-language pathologists, the Passy-Muir Valve is a valuable, non-invasive treatment intervention for dysphasia, facilitating therapy and enhancing patient outcomes. For respiratory therapists, the valve is an effective treatment for aspiration, secretion management, infection control and weaning. As a result of the Passy-Muir Valve, clinicians from all disciplines are able to communicate with their patients and better treat them through successful management of these common complications.
Research Indicated Additional Benefits
Over the years, the benefits and effectiveness of the Passy-Muir Valves have been the focus of more than forty independent research papers and clinical case studies. Based on this research, in July of 1995 Passy-Muir was successful in obtaining several additional indications for use of the Passy-Muir Valve from the FDA. David originally developed his valve specifically to improve communication. However, the clinical evidence that evolved through clinical use of the Passy-Muir Valve revealed that the Positive Closure design of the Passy-Muir Valve provided patients with the additional benefits of improved secretion management, improved olfaction, improved swallow and improved pulmonary function. The Passy-Muir Valves are the only speaking valves that have been research-validated and cleared by the FDA to provide these benefits.
Ethics, Directives and the Passy-Muir Valve
Over the past decade there has been an evolving consciousness in the medical field of quality of life issues and the importance of informed consent. Patient autonomy, individual rights, patient directives and durable power of attorney covenants have come to the forefront of healthcare and required the formation of biomedical ethics committees in many facilities. In this environment, the Passy-Muir Valve has emerged as a critical device in facilitating patient directed care. Significantly, the Passy-Muir Valve has been indicated by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) as an effective means for satisfying its requirement that hospitals provide the most optimal means of communication to every patient. Read the Case Study
National Consultant Program
The Passy-Muir, Inc. National Consultant Program was established in 1992 to educate healthcare professionals about the Passy-Muir Valves. This program brought together the expertise, commitment and spirit of leading clinicians in the treatment of tracheostomized and ventilator dependent patients. Many of the Passy-Muir consultants are authors of textbooks and presentations as well as the nation's most recognized researchers in this field. The consultants have served as a vital resource for educating other healthcare professionals and staff members at facilities across the country on use of the Passy-Muir Valve. This program has allowed Passy-Muir the unique opportunity to access and learn from the experts in the field who often work against great odds and complications to facilitate communication on a daily basis. Our consultants are the most knowledgeable, accomplished and committed specialists in their fields. As they educate clinicians on the importance of communication and use of the Passy-Muir Valve, they also provide their clinical feedback to Passy-Muir. We rely on this vital line of communication in order to continue improving our products and educational services. Learn more...
ISO Certification and CE Marking of Conformance
Commitment to quality has been a hallmark of Passy-Muir that is continually integrated into our products and services. As part of this commitment, we obtained the CE Marking of Conformance and ISO Certification (NSAI) in August, 1998. To meet the needs of our international clients we currently have translations of our clinical Instruction Booklet provided in French, German, Italian, Spanish, Portuguese and Japanese. Passy-Muir continues to be the industry leader with our premier line of communication products for tracheostomized and ventilator dependent patients. Learn more...
Passy-Muir continues to be the industry leader with our premier line of communciation products for tracheostomized & ventilator dependent patients. We at Passy-Muir believe that communication is the essence of the human spirit. It is essential to individual rights and dignity. We are committed in our efforts to offer tracheostomized and ventilator dependent patients a step towards independence and dignity through speech.