Interacting appropriately with industry – how compliance laws can affect you

Mr Paris Purnell1
1Hollister Incorporated, Libertyville, United States

Working with product manufacturers and suppliers (’Industry’) should at its best be a symbiotic relationship where both the healthcare professional (HCP) and the manufacturer derive mutual, yet appropriate benefits. This relationship should be driven by improving patient outcomes. Nevertheless, this affiliation can be challenging for maintaining objectivity and compliance for Industry and the HCP.

Recent global changes of compliance laws designed to govern these affiliations can make it difficult to ensure all parties remain compliant. However, the overall trend is toward transparency by Industry on any such interactions. These same considerations are increasingly becoming the focus of employers of HCPs as well as the HCP professional bodies.

The Medical Technology Association of Australia (MTAA) is the governing body regarding compliance for the medical devices industry that includes ostomy products. In Australia, there are strict codes of conduct and laws regarding interactions between HCPs and Industry including inducements (both active and passive), and anti-corruption. Disclosure of potential conflicts of interest (COI) are becoming best practice when developing such partnerships. There are cases now where nurses have been charged with corruption leading to fines and jail.

This presentation will focus on the global and local laws, codes, and market trends in compliance to better inform and protect the HCP, in this case the Stomal Therapy Nurse (STN).  By being more aware of the compliance requirements and legal ramifications when interacting with Industry, the STN will be in a better position to navigate such complex interactions that may place them at risk.


Biography:

Paris Purnell has spoken on a variety of ostomy-related topics at international conferences and local events as well as extensively published. His main focus has been the use of convexity with the stoma patient and he was instrumental in developing new guidelines for Patient Assessment for convexity which have been validated internationally. He is also focused on developing educational programs for developing countries to develop the ET Nurse role in Asia, Middle East, and Latin America.

Peristomal medical adhesive-related skin injury: International consensus development

Mr Ian  Whiteley1
1Concord Repatriation General Hospital , Concord , Australia

Introduction:

There is a growing awareness of skin injury related to the use of medical adhesives within the specialty of stoma care. This is an important issue affecting the peristomal skin as it can lead to skin tears, blisters, and skin infections such as folliculitis. There is a demand for better education regarding the identification and prevention of medical adhesive-related skin injury. Because there are so few studies to guide practice, an international panel of stoma care nurses (SCNs) was convened to discuss peristomal medical adhesive-related skin injury (PMARSI) and document areas of agreement about prevention and management.

Aims:

  • To reach consensus on a group of statements about PMARSI
  • Identify best practices in assessment, prevention and management
  • Identify gaps in research about PMARSI

Methods:

A literature search was conducted prior to the meeting and the panelists reviewed the results and conducted additional searches of relevant literature. These results were used by panel leaders to generate a list of consensus statements for discussion at the meeting. An anonymous electronic response system was used to report level of agreement. A process of moderated discussion was used to achieve consensus; defined as 80% agreement on each item. Agreement was attained on 21 statements about PMARSI.

Conclusions:

Peristomal medical adhesive-related skin injury is an important problem. Consensus on prevention and management strategies for PMARSI provides guidance to SCNs. Finding a common language to describe PMARSI will become best practice to ensure consistency within our specialty and potentially facilitate collection of data in this area.


Biography:

Ian Whiteley is the Nurse Practitioner in Stomal Therapy and Wound Care at Concord Repatriation General Hospital in Sydney, a position he has held since 2005.

Ian has academic affiliation as a Clinical Senior Lecturer with the University of Sydney Nursing School & Concord Clinical Medical School, Discipline of Surgery. He has published in national and international journals on a variety of topics.

The challenges in the management of a stoma patient with Dermatitis Artefacta

Mrs Mireille  Hamson1
1Salts Healthcare, Aston, United Kingdom

Aim

Skin integrity is crucial for skin health in stoma care and patients quality of life. In reality, peristomal skin complications are common and will effect 30-60% of stoma patients (Birch 2008). It is important to maintain healthy peristomal skin and this can be achieved through a peristomal skin assessment.  A peristomal skin assessment in vital for recognition and prompt appropriate treatments of these conditions.

Method

The purpose of this study is to discuss the challenges of Dermatitis Artefacta (DA). DA is a condition where lesion appear on the skin, that are produced or inflicted by the patient’s own actions, but the patient denies the self-harmed. It is a rare dermatological disorder, but it can often be difficult to diagnose and poorly understood by health professionals. We will demonstrate how a stoma patient with DA was managed in our stoma department and how this experienced has increased our knowledge and understanding of this rare disorder in stoma care.

Results

The case study will highlight the patient’s journey through the stoma care pathway and the delivery of care. It will demonstrate both physical and psychological challenges experienced by the hospital and community stoma teams, when caring for an individual with DA – indicating the importance of a team approach and collaboration in stoma management.

Conclusions

The management of a patient with DA is extremely challenging and multifaceted. There is very little evidence of DA in relation to stoma care and treatment can be varied. Patients with this condition can have significant impact on the stoma care service, due to their attention seeking behaviour

and complicated stoma issues. A clear strategy of stoma management is required to supervise and support both the patient’s physical and emotional issues.


Biography:

I have been a Stoma Care Nurse for the last 18 years in the UK. I currently work for Salts Healthcare as a Clinical Nurse Specialist in Innovation and practice 2 days a week as a Community Stoma Nurse.

AASTN

This conference is proudly hosted by the Australian Association of Stomal Therapy Nurses: www.stomaltherapy.com

One of the Association's major objectives is the promotion of quality care for a wide range of people with specific needs. These needs may be related to ostomy construction, urinary or faecal incontinence, wounds with or without tube insertion and breast surgery.

Patients/clients across the life span are provided with preventative, acute, rehabilitative and continuing care as required. Another objective is the maintenance and improvement of professional standards in relation to Stomal Therapy Nursing Practice to the highest degree possible. Recognition of the need for and encouragement of the development of specialist expertise in the field of Stomal Therapy Nursing underpins the Standards for Stomal Therapy Nursing Practice.

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