The Company’s integrity and culture imposes upon each employee and on our business partners the obligation to comply with all laws, rules and regulations that govern multiple aspects of our business. The Company allocates significant resources in the form of a dedicated compliance team, employee and business partner training, systems development and written policies and procedures to ensure each employee and business partner has a clear expectation as to his or her role in enabling DJO to remain in compliance.
Compliance Hotline
As part of DJO’s commitment to transparency regarding laws and regulations and to maintain a safe and secure workplace, the Company has established a hotline for employees to report illegal, unethical or unsafe situations. The hotline provides an anonymous method, if the employee so chooses, to report any instances of misconduct regarding the Company’s finances or other business situations. Furthermore, the Company prohibits retaliation against any employee who, in good faith, reports a violation.
Patient Privacy Compliance
DJO complies with Federal laws regarding the privacy of health information that identifies or that could be used to identify patients. We understand the importance of safeguarding all medical information and are firmly committed to protecting the privacy of the patients we serve. Towards that end, DJO employees are carefully trained to protect patient privacy and promote a corporate culture of respect for the confidential patient information in our possession.
Click here to view the DJO Notice of Privacy Practices.
Health Care Compliance
The DJO Health Care Compliance Program is designed to specifically address the portion of the Company that functions as a Durable Medical Equipment, Prosthetics and Orthotics (“DMEPOS”) Supplier, and incorporates the seven elements recommended by the Department of Health and Human Services Office of the Inspector General. The program serves to promote effective internal controls and adherence to applicable federal and state laws, as well as the requirements of private payors. The program is also intended to help promote the provision of quality products, services, and care to DJO patients.
Click here for an overview of the elements of the DJO Health Care Compliance & Ethics Program .
Product Compliance
As a world-wide provider of medical devices based in the United States, DJO designs, manufactures and distributes our products in accordance with Title 21 of the Code of Federal Regulations, Subpart 820, Quality System Regulation of the U.S. Food and Drug Administration. DJO’s Quality Management System is also harmonized with global medical device regulations and internationally recognized quality standards in order to meet or exceed the expectations of our customers and maintain compliance with all applicable regulatory requirements. Accordingly, our Quality Management System is certified for compliance to ISO 13485:2003, the European Council (EC) Directive 93/42/EEC and the Canadian Medical Device Regulations. In order to ensure continued compliance, our design and manufacturing facilities are subject to audit once every two years by the US Food and Drug Administration, annually by an independent third-party quality system Registrar and periodically by trained, internal DJO auditors.
Accounting & Finance Compliance
The senior Accounting and Finance leadership team oversees the application of critical accounting policies and analyzes financial metrics to monitor the strategic direction of the Company. The team regularly discusses the application of controllership metrics as well as new or upcoming accounting policies. DJO adheres to a rigorous set of accounting policies and devotes significant resources to ensuring that those policies are applied properly and consistently throughout the organization.
DJO management reviews the financial operating results and associated metrics with the Audit Committee of the Board of Directors. In addition, the Audit Committee reviews the outcome of internal audits and the Sarbanes-Oxley 404 certification.
The Company maintains a dynamic system of internal control designed to ensure reliable financial reporting and the safeguarding of assets. The Company’s continued commitment to internal control enabled the Company to complete the evaluation of internal controls over financial reporting that is required by Section 404 of the Sarbanes-Oxley Act.
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Last Updated: 12/9/2008
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