Arthrex is committed to the highest standards of conduct and corporate compliance. As such, we have established a comprehensive compliance program to prevent and detect violations of our Code of Conduct, company policies, and applicable laws and regulations.
This program was established to protect the integrity of Arthrex and to hold all who conduct business on behalf of the company accountable to a set of generally accepted employment standards and workplace practices. This program is a key component of our commitment to fostering a culture of compliance and leading with integrity.
Our Program Components:
Arthrex’s Risk Management & Compliance Program is led by a Global Chief Compliance Officer with the full support of the company’s President and Founder, to whom the Global Chief Compliance Officer reports. Our Global Chief Compliance Officer is charged with the responsibility of establishing and maintaining the global Risk Management & Compliance Program and does so in conjunction with four Regional Compliance Officers who supervise the program in each of their respective regions. The Global Chief Compliance Officer provides regular updates to the Global Compliance Committee which provides strategic direction and oversight in the management of risk and the implementation of the company’s compliance program.
Assessment and Management of Risk
Arthrex conducts regular risk assessments to help identify events that, considering the likelihood and impact of a given outcome, could affect the achievement of the company’s objectives. Our program’s risk management function develops solutions to identify and mitigate risk effectively, working closely with the business to implement necessary controls.
Policies and Procedures
Arthrex sets forth written standards, such as our Code of Conduct, and global policies and procedures. These standards are intended to help Arthrex comply with relevant laws and regulations, industry codes and best practices. Foundational to our company, is the Arthrex Code of Conduct, which represents the culture, values, and principles we expect our employees and third parties to uphold. View the Arthrex Code of Conduct.
Training and Communications
Critical to the success of the compliance program is each individual employee's understanding of the policies and procedures that have been established as part of that program. Arthrex is committed to implementing a program that effectively communicates company policies and procedures to its employees and other personnel, to ensure they have an understanding and appreciation for appropriate business conduct and decision-making. Arthrex implements a risk-based training program that is tailored to relevant roles in the company. The company regularly reviews and updates its training and communications program to ensure effectiveness and identifies additional areas of training as needed.
Arthrex promotes an environment where employees can raise questions and concerns without fear of retaliation, and offers several resources for reporting violations, which are promoted on the employee intranet and through other channels. View additional information about Arthrex’s Ethics Helpline.
Monitoring and Auditing
Arthrex uses auditing and monitoring to verify that the business practices engaged in by its employees and third parties follow the various policies and procedures that are in place to ensure compliance with the laws and regulations applicable to the company. This includes a robust Third-Party Management Program designed to conduct due diligence and continuous monitoring across our global third-party network. The extent and frequency of the company's auditing and monitoring activities varies according to a number of factors, including new regulatory requirements and changes in business practices.
Arthrex’s program includes immediate response, investigation, and corrective action as a result of reported compliance issues or audit findings. Assessments are made as to whether the non compliance is due to gaps in policies, training, and/or internal controls and appropriate action is taken to prevent future non compliance.
Our Compliance Program is in accordance with the Compliance Program Guidance for Pharmaceutical Manufacturers published by the United States Department of Health and Human Services Office of Inspector General (OIG), as well as the Code of Ethics on Interactions with Health Care Professionals published by the Advanced Medical Technology Association (''AdvaMed'').
The Arthrex Compliance Program recognizes that compliance is dynamic. It provides for revisions when necessary to reflect changes in company operations, the OIG's Compliance Program Guidance, and the AdvaMed Code.
The Arthrex Compliance Program is tailored to the size, structure, operational activities, and resources of the organization, and to meet compliance goals consistent with our corporate ethics and with the statutory requirements of California Health and Safety Code §§119400-119402.
To the best of our knowledge, Arthrex is in material compliance with both the Compliance Program and California Health and Safety Code §§119400-119402. As recognized by the OIG, a manufacturer's implementation of a compliance program may not entirely eliminate improper conduct by employees. However, Arthrex expects all of its employees to fully comply with its Compliance Program, and Arthrex takes all reasonably necessary steps to detect, prevent, investigate, and properly address violations of its program.
You may access a written copy of this declaration in our Comprehensive Healthcare Regulatory Compliance Plan or call 1-800-933-7001.