Insights

SAWC Spring 2024 Fistula Challenge Winners!

Fistula Solution once again drew crowds with the Wound and Fistula Coloring Contest at SAWC Spring 2024. Our judges faced a veritable Sistine Chapel ceiling of complexity in choosing the top entries, but after much spirited debate three masterpieces emerged, dripping with talent, vibrant hues, and sheer intensity.

Second Runner Up

In the grand tradition of Leonardo da Vinci's anatomical sketches, Joan Black from HCA Northwest Hospital presented us with a modern twist on the Renaissance master's detailed studies of hands. Her work featured the subtle play of color to depict a potential triple fistula. Imagine a Jackson Pollock-esque effusion, where the high-volume effluent splatters with wild abandon, illustrating the patient's rather, shall we say, hands-on approach to their own care. The psychological intricacies of such scenarios certainly require a touch of Freud, making a mental health expert an essential part of the fistula care team.

3rd SAWC Spring 24 copy

First Runner Up

Tabassum Merchant from Orlando Health delivered a visual feast reminiscent of Hiroshi Sugimoto's tranquil yet evocative seascapes. Her piece features a fistula triplet serenely coexisting with an ostomy stoma within a challenging wound bed. The subtle, soothing use of color belies the chaotic reality of managing a sloughy wound with uncontrolled effluent. Ensuring patients’ nutritional needs are met to support healing calls for a nutritionist skilled in the delicate art of short bowel syndrome management – think of them as the culinary Picasso of the medical world.

2nd SAWC Spring 24 copy

First Place

And the pièce de résistance, the crowning jewel, goes to Jeanne Ozinga of OU Medical Center. Channeling the vibrant spirit of fellow Sooner artist Eugene Bavinger, her masterpiece is a symphony of color and complexity. It vividly captures the Herculean challenges of managing a complex open abdomen case, featuring an open wound, exposed bowel, enteric fistulas, urostomy and ostomy stomas, eschar, slough, and – wait for it – pieces of ham. This tableau of medical drama demands a multidisciplinary team worthy of a Michelangelo fresco, including a WOC nurses, surgeons, physician assistants, nutritionists, psychologists, and families, and also Fistula Solution!

A standing ovation to all our artists and their awe-inspiring entries! We eagerly anticipate another round of creative brilliance at WOCNext 2024!

SAWC Fall 2023 Fistula Challenge Winners!

Fistula Solution is proud to unveil the champions of the 2023 SAWC Fall Fistula Coloring Contest! The judges faced a daunting task selecting the top drawings from a talented pool of entries, but after much deliberation decided that three of the entries clearly rose to the top in terms of the inherent meaning and intent of the works and skill and technique of the artists.

Second Runner Up

In a stroke of artistic genius, Tracey Yap, Katie Brooks, and Jenny Alderden from Duke University School of Nursing unleashed their interpretation of an open abdomen with a dash of Monet and a pinch of vino-inspired impressionism. Their canvas is a soothing oasis of smooth lines and colors that whisper, "Relax, it's just an open abdomen with exposed bowel and a possible fistula." In such moments, the prescription is conservative management, using large wound managers and moist wound healing while waiting for the patient to become healthy and suspected fistulas to define themselves.

2d runner up cropped

First Runner Up

Kurt Holifield from Vitality Advanced Wound Care took us on a mesmerizing journey into the problematic world of hernia mesh-induced enteric fistulas. His artwork, a captivating blend of Picasso's Blue Period and Dr. Michael Desvign's inspiration, masterfully underscores the importance of the SNAP methodology in fistula management: Skin and Sepsis, Nutrition, definition of fistula Anatomy, and a definitive Procedure to repair the fistula. The anatomical callouts in his drawing emphasize the paramount importance of comprehending the fistula's anatomy beneath the skin. Knowledge of the fistula's distal bowel continuity (or lack thereof) is the key to SNAP management success.

1st runner up cropped

First Place

The spotlight shines brightest on Donna Garrett from Mercy Wound Clinic, whose vivid use of color screams the raw frustration that enteric fistulas can unleash on patients, providers, administrators, and distraught family members. Her artwork nods to Edvard Munch, encapsulating the rollercoaster of emotions from despair to hope that patients ride during their long fistula journeys. But that's not all! Donna's masterpiece also pays tribute to the unsung heroes in the epic tale of care plans—a multidisciplinary team that includes WOC nurses, surgeons, physician assistants, nutritionists, psychologists, and families, and also Fistula Solution!

Exciting Opportunities Await at SAWC Fall 2023!

Excitement is building as we gear up for SAWC Fall 2023, set to take place from November 2nd to 5th in the vibrant city of Las Vegas, Nevada. This event promises to be a hub of knowledge, innovation, and networking in the wound care industry.

1. Explore Booth #742

When you attend SAWC Fall 2023, make sure to add our booth, #742, to your must-visit list. Here, you'll find a treasure trove of information and the latest updates. But that's not all! Explore the convenience of purchasing our cutting-edge devices directly from Fistula Solution. You won't want to miss this chance to see a demonstration of our fistula devices up close and learn about our recent shift to direct distribution.

2. Complex Wounds or Fistulas? We've Got You Covered

For those grappling with challenging complex wounds or fistula cases, we have a special treat in store for you. At Booth 742, you can meet Mary Anne Obst from Complex Wounds and Fistulas. Mary Anne brings a wealth of knowledge and experience, and she's ready to collaborate with you to explore innovative solutions.

3. Dive Deeper

To learn more about our offerings and how we can help you tackle complex wound care challenges, be sure to visit our website at Fistula Solution. Here, you'll find additional information, resources, and a glimpse of what you can expect when you engage with us at SAWC Fall 2023.

In conclusion, SAWC Fall 2023 is an opportunity you won't want to miss. Whether you're looking for the latest wound care solutions, insights on complex wound cases, or simply eager to network with industry experts, we've got you covered. Be prepared for a productive and enlightening experience at this year's SAWC Fall.

For all the event details and updates, don't forget to visit the official SAWC Fall 2023 website at www.sawcfall.com. We can't wait to see you there!

Fistula Solution to Showcase Innovations at The MedTech Conference 2023

We are excited to announce that Fistula Solution Corporation has been chosen to present at The MedTech Conference, a significant event in the medical device industry. The conference is scheduled to take place in Anaheim, CA, from October 9th to October 11th. This in-person gathering is an important platform for the MedTech sector, bringing together more than 3,500 industry executives to exchange knowledge and foster collaboration.

Fistula Solution Corporation has been selected by the National Institutes of Health (NIH) to participate in the Innovation Pavilion. This section is dedicated to showcasing innovations from 36 early-stage companies, offering valuable exposure and networking opportunities for NIH grant recipients.

During the conference, Fistula Solution aims to engage with:

  • Potential strategic partners interested in development and distribution
  • Investors looking for opportunities in commercialization
  • Individuals passionate about addressing challenges related to enteric fistula, ostomy, and complex wound patients

Click here to learn more.

Fistula Solution Releases Improved Fistula Funnel!

Fistula Solution is delighted to announce enhancements to our Fistula Funnel! Building on its success, the Fistula Funnel will maintain its exceptional features, including its tapered, flexible design and a 2-centimeter inside center diameter. However, based on valuable feedback from clinicians, we have implemented several performance enhancements, ensuring an even more effective and user-friendly experience. These enhancements include:

  1. Expanded Sizing Options: We have widened the end openings of the Fistula Funnel, providing healthcare providers with a greater range of sizing choices. This improvement enables clinicians to tailor the funnel precisely to individual patient needs.
  2. Streamlined Design: Our team has optimized the Fistula Funnel to fit in narrow situations. This streamlined design improves usability in crevices and near side walls.
  3. Intuitive Tailoring: In response to user feedback, we have introduced a new exterior scribe line to the Fistula Funnel. This innovative addition simplifies the tailoring process, making it more intuitive for clinicians.

The Fistula Funnel represents our smallest diameter barrier ring option, designed to compress the skin surrounding an enteric fistula, stoma, or drain. Its primary purpose is to create a secure seal that effectively protects the skin from effluent. This remarkable device is particularly suitable for:

  • Small-sized fistulas and stomas
  • Sidewall fistulas
  • Challenging crevice areas
  • Isolating fecal management system leakage

At Fistula Solution, we are dedicated to continuously improving our products to meet the evolving needs of clinicians and patients. With these enhancements to the Fistula Funnel we remain committed to providing the highest quality solutions for managing enteric fistulas and stomas.

Stay tuned for further updates and information on how the enhanced Fistula Funnel can revolutionize your clinical practice.

Click here to learn more.

Fistula Fiesta at WOW! Exploring Innovative Management Techniques for a Complex Challenge

Are you a dedicated healthcare professional seeking to expand your knowledge and skills in advanced wound care? Look no further! The Wild on Wounds (WOW) conference in Hollywood, Florida, is back with its impactful, hands-on wound care education. This year, the spotlight is on the "Fistula Fiesta" session - a unique opportunity to explore effective management techniques for the complex challenge of fistulas.

An Insightful Journey into Fistula Management

On September 16, 2023, the WOW conference will offer a comprehensive look into the management of fistulas. These challenging wounds can have a profound impact on both patients and their caregivers, making it crucial for healthcare professionals to stay informed about the latest advancements in treatment and care.

Unraveling the "Fistula Fiesta" Session

Designed specifically to address the complexities of fistulas, the "Fistula Fiesta" session will focus on the unique difficulties faced by patients and caregivers alike. Whether you're a nurse, a physical therapist, or an occupational therapist, this session will equip you with valuable insights and skills to effectively manage this intricate wound condition.

The Significance of Fistula Management

Fistulas pose significant challenges, often requiring a multidisciplinary approach to achieve the best outcomes for patients. Moreover, the psychological impact on patients and their families should not be underestimated. This session aims to illuminate the best practices in fistula management, empowering attendees to provide better care and support to their patients.

What You'll Learn

By attending the Fistula Fiesta session, you'll have the opportunity to achieve several key learning objectives, including:

  • Identifying three common types of fistulas that develop in patients.
  • Comparing different types of fistula management devices available on the market, allowing you to make informed choices tailored to your patients' unique needs.

Your Expert Guide - Emily Greenstein

Leading the Fistula Fiesta session is the experienced Emily Greenstein, APRN, CNP, CWON-AP, FACCWS, from Sanford Health in Fargo, ND. Emily's wealth of knowledge and expertise makes her the perfect guide to navigate the complexities of fistula management. With her board certifications in Wound and Ostomy Care and 14 years of experience, she is dedicated to advancing wound care practices and providing optimal patient outcomes.

Join the Fiesta, Enhance Your Expertise!

The Fistula Fiesta session at WOW promises to be an illuminating experience, providing you with valuable insights and skills to tackle the challenges of fistula management with confidence. Whether you're a seasoned healthcare professional or just starting your wound care journey, this session offers something for everyone.

Don't miss out on this enriching opportunity! Click here to learn more about the event and the Fistula Fiesta session.

Fistula Solution Distribution Changes

3M’s distribution agreement for Fistula Solution® devices will end August 22, 2023.  As we approach the end date there will be a point where these products will no longer be available for purchase through 3M.

For our esteemed customers in the United States, we want to assure you that Fistula Solution devices will continue to be available directly from Fistula Solution. To ensure a seamless transition and uninterrupted supply, we kindly request that US customers visit our Order page before July 30, 2023, to update their Fistula Solution account information and establish their ordering process.

To our customers outside of the United States, we regret to inform you that Fistula Solution devices will be temporarily unavailable until we reestablish distribution channels. We understand the inconvenience this will cause for our providers and patients, and we sincerely apologize for this unfortunate situation.

Our primary objective is to minimize the impact of these changes while simultaneously improving our products and services. As part of this transition, our US customers will have access to new options such as express/overnight shipping, a new mixed device pack, and P-card ordering. These enhancements are aimed at benefiting both patients and providers, and we are thrilled to have the opportunity to serve you in this capacity.

We deeply value your continued support, and we remain committed to our priorities of healing the patient and assuring health care providers are successful in the delivery of care.

Thank you for your understanding and cooperation throughout this transition period.

Sincerely,

Your Fistula Solution Team.

Fistula Solution Receives FDA Breakthrough Device Designation for Innovative Limpet Device, Advancing Enterocutaneous Fistula Care

  • Breakthrough Device Designations are given by the U.S. FDA to expedite the review of technologies that can improve the lives of people with life-threatening or debilitating conditions.
  • Each year, tens of thousands of Americans suffer from enterocutaneous fistulas (ECF).
  • With Breakthrough Device Designation the Limpet™ Device could become available as a new treatment option sooner for these patients.

Fistula Solution, a leading medical device company in complex wound care, announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the Limpet™ device for severe abdominal openings unlikely to spontaneously close. This device is designed to reduce current complications associated with enterocutaneous fistulas, which has the potential to reduce healthcare costs and improve patient confidence and quality of life.

Enterocutaneous and other enteric, or intestinal, fistulas are challenging to manage, and the current standard of care is costly. In terms of charges billed to patients, the median total charges per hospital stay are $50,451, with a range of $24,439 to $109,4343.  The annual costs of enteric fistulas on the healthcare system are estimated to be close to $500,000,000. Additionally, the charges incurred by enteric fistula patients amount to approximately $1.5 billion.  These figures indicate the significant financial burden that enteric fistula patients impose on the healthcare system, highlighting the importance of effective management and prevention strategies for this condition.

The Limpet combines key aspects of fistula management — effluent containment and negative pressure wound therapy for effluent management and promotion of healing of intact and injured skin. The protection of the negative pressure dressing also simplifies nursing care, eliminates the need for frequent dressing changes, and protects the surrounding skin or wound, which all promote the patient’s global health.

“The Breakthrough Device Designation is a significant milestone for our company and validates our belief that the Limpet™ device has advantages over the current standard of care,” said Andy Obst, President of Fistula Solution. “Early clinical results are promising and suggest our device reduces the complications typically associated with fistulas and ostomies and better supports a patient’s ability to get back to life. We look forward to working with the FDA to make the technology accessible as quickly as possible.”

Early clinical data comparing the Limpet with the current standard of care demonstrated that the Limpet achieves a 99.4% average reduction in skin damage area or near total control of intestinal effluent for patients with enteric fistula complications. The Limpet was worn for an average of 3 days versus the 0.26 days for conventional dressings and showed zero leak failures in 14 device placements over 65 days of therapy, reducing patient or caregiver maintenance.  Additionally, patients with new skin grafts around their fistula experienced 95% graft take, which is remarkable because grafting around stomas is generally not feasible with conventional dressings.

The FDA Breakthrough Device program is designed to help accelerate the development and approval of medical devices and products that have the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.  Receiving the Breakthrough Device Designation also facilitates the Medicare coverage for the device, which will help the Limpet device become more widely accessible for patients who require an ostomy procedure or develop enteric fistulas, benefitting both the healthcare system and the patient.

 

About Fistula Solution

Fistula Solution has a portfolio of devices designed to treat enteric fistulas and high output ostomy stomas. The company is committed to developing innovative new devices for post-surgical ostomy complications, rectovaginal fistulas, surgical drain wounds, and necrotizing soft tissue infections.

For further information visit www.fistulasolution.com.

 

  1. Moisture-Associated Skin Damage (MASD) | WoundSource
  2. Taneja, Charu, et al. "Clinical and economic burden of peristomal skin complications in patients with recent ostomies." Journal of Wound, Ostomy, and Continence Nursing 44.4 (2017): 350.
  3. Brooks NE, Idrees JJ, Steinhagen E, Giglia M, Stein SL. The impact of enteric fistulas on US hospital systems. Am J Surg. 2021;221(1):26-29. doi:10.1016/j.amjsurg.2020.06.017

Fistula Solution Corporation Financial Conflict of Interest (FCOI) Policy

PURPOSE

The purpose of this policy is to document the requirements and responsibilities associated with identifying and managing financial conflicts of interest to safeguard the integrity of Fistula Solution Corporation (Company) research and to comply with federal regulations.

This policy has been developed to address and comply with the specific federal agency requirements as defined in the 2011 Revised Financial Conflict of Interest Regulation, Promoting Objectivity in Research (42 CFR part 50 subpart F). This regulation was developed to promote objectivity in research by establishing standards that provide a reasonable expectation ensuring the design, conduct and reporting of research funded under National Institutes of Health (NIH) grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest.

SUMMARY OF PROCESS

Significant Financial Interests (SFI) (as defined below) shall be disclosed on the Significant Financial Interest Disclosure Form by an Investigator requesting government-sponsored or company-sponsored funds for a research project or by an Investigator when a Significant Financial Interest arises during the course of research. Regardless of whether a SFI exists, all Investigators and key personnel are required to submit a SFI Disclosure Form annually.

It is the Principal Investigator's responsibility to ensure those with financial interests in research are identified and make the required disclosures in conjunction with submission of a research proposal or application for human subjects’ approval.

The Company President is the designated Institutional Official. The Significant Financial Disclosure Form and supporting materials are forwarded to the Company President for review. The Finance Department will be responsible for evaluating and instituting a plan for managing any disclosed financial interests, for producing institutional reports and other required reports to external sponsors and governmental agencies, and for the general administration and enforcement of this policy.

Advance approval by the President is required prior to engaging in government-sponsored research. A SFI review must be completed before any expenses are incurred under an award.

Annual updates are required of all Investigators and key personnel participating in research. Any Investigator who has acquired a new or increased financial interest during the course of a research project shall report it immediately to the President. Annual updates and newly acquired interests are reported using the Significant Financial Interest Disclosure Form.

TRAINING

The NIH Financial Conflict of Interest tutorial was designed by the National Institutes of Health (NIH) to provide education training on what constitutes financial conflict of interest. This course is required for anyone involved with an NIH funded project, which includes all Investigators, consultants and employees of Fistula Solution Corporation engaged in NIH-funded research or its compliance.

The course is accessible at https://grants.nih.gov/grants/policy/coi/fcoi-training.htm. Upon completion of the training, a certificate of completion must be turned into the President. You should retain a copy for your records. This training is required prior to engaging in research relating to any NIH-funded grant or as deemed necessary by the Company due to changes in the FCOI policy, non-compliance of the Investigator/Key Personnel or new hires to the Company. At a minimum, the FCOI training shall be taken every three (3) years.

KEY DEFINITIONS

The following definitions are provided as a reference and are considered key definitions in understanding the federal regulations of FCOI. A complete list of official definitions can be found at https://www.ecfr.gov/current/title-42/chapter-I/subchapter-D/part-50/subpart-F.

Financial conflict of interest (FCOI) means a significant financial interest that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.

Institution means any domestic or foreign, public or private, entity or organization (excluding a Federal agency) that is applying for, or that receives, PHS research funding.

Institutional responsibilities means an Investigator's professional responsibilities on behalf of the Institution, and as defined by the Institution in its policy on financial conflicts of interest, which may include for example: activities such as research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.

Investigator means the project director or principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the PHS, or proposed for such funding, which may include, for example, collaborators or consultants.

Manage means taking action to address a financial conflict of interest, which can include reducing or eliminating the financial conflict of interest, to ensure, to the extent possible, that the design, conduct, and reporting of research will be free from bias.

PD/PI means a Project Director or Principal Investigator of a PHS-funded research project; the PD/PI is included in the definitions of senior/key personnel and Investigator.

PHS means the Public Health Service of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority involved may be delegated, including the National Institutes of Health (NIH).

Senior/key personnel means the PD/PI and any other person identified as senior/key personnel by the Institution in the grant application, progress report, or any other report submitted to the PHS by the Institution.

Significant financial interest (SFI) means:

(1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator's spouse and dependent children) that reasonably appears to be related to the Investigator's institutional responsibilities:

(i) With regard to any publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value;
(ii) With regard to any non-publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator's spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest); or
(iii) Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.

(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available), related to their institutional responsibilities; provided, however, that this disclosure requirement does not apply to travel that is reimbursed or sponsored by a Federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education. The Institution's FCOI policy will specify the details of this disclosure, which will include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. In accordance with the Institution's FCOI policy, the institutional official(s) will determine if further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes an FCOI with the PHS-funded research.

(3) The term significant financial interest does not include the following types of financial interests: salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution, including intellectual property rights assigned to the Institution and agreements to share in royalties related to such rights; any ownership interest in the Institution held by the Investigator, if the Institution is a commercial or for-profit organization; income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles; income from seminars, lectures, or teaching engagements sponsored by a Federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education; or income from service on advisory committees or review panels for a Federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.

PROCEDURES

A. Identification of Persons Required to Disclose a Significant Financial Interest - It shall be the responsibility of the Principal Investigator of a Research project to identify all Investigators who have a SFI requiring disclosure under this policy and to ensure that a SFI Disclosure Form is prepared and submitted. In addition, the Principal Investigator shall be responsible for ensuring that annual updates and disclosures of new or increased financial interests are disclosed.

B. Submission and Review of Significant Financial Interest Disclosure Form - Every individual having a SFI requiring disclosure under this policy shall prepare a fully-completed SFI Disclosure Form that shall be submitted to the President. An initial review of the SFI Disclosure Form will be conducted by the President to determine whether a potential for conflict of interest exists. If it is determined that there is a potential conflict of interest, then steps will be taken to determine what measures are needed to address the SFI identified in the SFI Disclosure Form. A management plan may be required to outline the terms, conditions and restrictions, if any, to ensure compliance with this policy. The management plan may require one or more of the following actions (but not limited to) to be taken in order to manage, reduce or eliminate any actual or potential conflict of interest:

  • Public disclosure of significant financial interests;
  • Review of research protocols by independent reviewers;
  • Monitoring of research by independent reviewers;
  • Modification of research plan;
  • Disqualification from participation in all or a portion of the research funded;
  • Divesture of significant financial interests;
  • Severance of relationships that create actual or potential conflicts

All management plans are required to be signed by the Investigator and the President. Compliance of the management plan shall be monitored by the Finance Department.

C. Annual Reporting and After-Acquired Significant Financial Interests – All Investigators shall provide annual SFI Disclosure reports or more frequently if required by the management plan. Any Investigator who acquires a new or increased SFI shall promptly submit a new SFI Disclosure Form within 30 days of discovering or acquiring the new SFI. It is the Principal Investigator’s responsibility to ensure that any newly acquired Investigator on a research project submits the required SFI report to the President.

D. Violations of Conflict of Interest Policy – Investigators are expected to comply fully and promptly with this policy. Whenever a person has violated this policy, including failure to make a required disclosure of financial interests or failure to comply with a requirement of the management plan, the President shall plan and manage the impositions of sanctions or disciplinary proceedings against the violating individual.
In addition, the Company shall follow Federal regulations regarding the notification of the sponsoring agency in the event an Investigator has failed to comply with this policy. The federal agency may take its own action as it deems appropriate, including the suspension of the funding for the Investigator until the matter is resolved.

E. Record Keeping – Records of Investigator SFI Disclosure forms, and of actions taken to manage actual or potential conflicts of interest, shall be retained by the Finance Department for three (3) years from the date the final expenditure report is submitted to the NIH, or as required by 45 CFR 74.53(b) and 92.42(b) for different situations.

F. Sub-recipient Requirements – Sub-award recipients must comply with this policy or provide certification that their organization is in compliance with the Federal policy, 2011 Revised Financial Conflict of Interest Regulation, Promoting Objectivity in Research (42 CFR part 50 subpart F) and that their portion of the research project, as detailed in their sub-award agreement, is in compliance with their institutional policies. If a SFI is identified by the sub-award recipient, they are required to notify the President of the existence of the conflicting interest within 30 days of the identification of the interest. In addition, the sub-award recipient must certify and assure that any reported conflicting interest has been managed, reduced or eliminated in accordance with federal regulations.

G. Federal Reporting – The Finance Department is responsible for the reporting disposition of matters involving disclosures of SFI in accordance with applicable federal requirements. Report the existence of any identified financial conflicts of interest via the NIH via FCOI Module https://www.era.nih.gov/erahelp/commons/Commons/FCOI/fcoi_module.htm.

The following reports are required by the NIH:
i. Initial report – prior to the Company’s expenditure of any funds under a NIH-funded research project, the Company must provide to the NIH an FCOI report regarding any Investigator SFI found by the Company to be a financial conflict of interest in accordance with the regulation.
ii. During on-going NIH-funded research projects – the Company shall submit an FCOI report within 60 days after its determination that a new FCOI exists. If a FCOI was not disclosed timely, the Company shall submit a FCOI report to the NIH within 60 days of the discovery, as well as complete a retrospective review within 120 days of discovery of noncompliance.
iii. Annual FCOI report – For any FCOI previously reported to the NIH, the Company shall provide an annual FCOI report addressing the status of the FCOI and any changes to its related management plan.

How to Win the NSTI Battle at SAWC Spring 2022!

Attend the session Necrotizing Soft Tissue Infection: How to Win the Battle to experience the largest and most challenging wounds at SAWC Spring.

Learn critical decision making processes for effective surgical and wound care of NSTI and Fournier's gangrene. Surgical debridement videos will demonstrate the latest methods for removing infected tissue while preserving critical structures. Cases will illustrate wound care techniques for patients with debridements of 1000's of square centimeters and application tips to VAC seemingly “unVACable” patients.

SAWC Spring 2022 is April 6-10.  Register here.