2015 Corporate Sustainability Report: Principles

Principles

Health care professionals review patient results on a clipboard

At St. Jude Medical, we believe in partnering with health care providers, patients and our communities to create medical solutions that save and improve millions of lives worldwide—while reducing health care costs for all.

Our Commitments

  • We are committed to meeting and exceeding the highest quality expectations.
  • We are committed to pursuing new treatments, efficiencies and ideas that improve the lives of people affected by costly diseases.
  • We are committed to maintaining the highest ethical standards in all business practices and are dedicated to doing what is right.
  • We are committed to continually adapting to the rapidly changing health care environment.
  • We are committed to partnering with physicians, health care administrators and payers to find answers to the challenges they face.

Product Quality and Safety

St. Jude Medical has a strong history of product quality, safety and reliability, and we remain dedicated to developing technologies and products that save and improve the lives of patients. Our goal as a global medical device manufacturer is to produce devices of industry-leading quality that function safely and properly every time. Learn more about our commitment to quality

Product Lifecycle

St. Jude Medical strives to produce the highest-quality products in an efficient and cost-effective way. This is how we deliver the most value to our business and ensure our customers and patients have what they need, when they need it.

Our integrated end-to-end supply chain structure allows us to leverage global economies of scale and standardize best processes across all operations at every facility. Our work over the last year has created more efficient and effective processes to strengthen our U.S. distribution and logistics, sourcing/purchasing and supplier engagement, and product inventory and flow.

Global Standards

We take responsibility for understanding and managing the environmental risks of our products and work to meet the continually increasing demands of the environmental regulatory landscape. Through a balanced approach of systematically tracking information and the involvement of senior management, we comply with applicable legislation around the world (e.g., EU REACH, Waste streams, Battery, RoHS in EEE, packaging).

RoHS Compliance

All St. Jude Medical™ products placed on the market comply with the provisions of the European Union’s 2015/863/EU Restriction of Hazardous Substances (RoHS) Directive.

Waste Management

St. Jude Medical is dedicated to addressing local, state, national and international legislation for the management of electronic waste, including the European Union’s Waste Electrical and Electronic Equipment (WEEE) Directive 2002/96/EC which regulates the collection, treatment and recycling of electronic products. Our devices, cables and accessories, which depend on electrical current to operate properly, are appropriately labeled with the WEEE symbol indicating that they should be collected separately to a designated recycling service. Additionally, St. Jude Medical ensures that battery suppliers comply with labeling requirements of Directive 2006/66/EC of the European Parliament and of the Council of September 6, 2006.

Packaging Waste Reduction and Electronic Labeling

St. Jude Medical is dedicated to reducing the amount and toxicity of its packaging waste. Our engineers strive to decrease environmental impact through packaging reduction and use of environmentally friendly materials. Our current work is to eliminate paper IFU manuals and use electronic manuals, resulting in considerable paper waste reduction. Additionally, projects are ongoing to eliminate DEHP (Bis(2-ethylhexyl) phthalate) from St. Jude Medical products.

REACH compliance

At the direction of senior leadership, specific resources have been assigned to meet the requirements of the Regulation 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). While maintaining the high quality of our products, we work closely with our suppliers, where possible, to eliminate the use of substances of very high concern (SVHCs) in the production of our devices. However, in the cases where no suitable alternative exists, we have put into place a process to address any safety concerns that may be raised by our customers. In addition, St. Jude Medical products are assessed for biocompatibility.

Conflict Minerals

St. Jude Medical is actively complying with its obligations under the conflict minerals legislation and aims to build transparency in its supply chains by identifying vendors who may use conflict minerals in the products they supply to us. Read our policy

California Transparency in Supply Chain Act

Since our company’s start, St. Jude Medical has always led its business with integrity, focused on complying with applicable laws and regulations. We are committed to conducting business with suppliers who support St. Jude Medical’s high standards of ethical conduct. We support the humanitarian goal of eliminating slavery and human trafficking in supply chains. Read our policy.

Ethical Business Conduct

We believe that ethical business behavior is paramount to a business’s success, integrity and sustainability. The St. Jude Medical Code of Business Conduct not only serves as the framework for upholding responsible actions and beliefs, but also helps demonstrate our commitment to complying with applicable laws and regulations.

The Code of Business Conduct applies globally to all St. Jude Medical employees and has been translated into several languages. In addition to conducting our business with integrity, we are committed to complying with laws around the world that apply to our business and working with integrity when dealing with fellow employees, customers, patients, vendors, shareholders, securities analysts, the media or regulators.

Each new employee receives a copy of the St. Jude Medical Code of Business Conduct and can also access it on our web and intranet sites and through annual training. St. Jude Medical has made a concerted effort to promote the Code of Business Conduct internally, including electronic training on relevant topics and cross-referencing in other policies and procedures. All St. Jude Medical employees are expected to be familiar with and adhere to the Code.

Our Code of Business Conduct obligates each employee to do the right thing and report an actual or apparent violation of the law or company policy. Employees and representatives are also encouraged to raise questions pertaining to business integrity, including conduct of a St. Jude Medical employee or anyone else representing the company. Issues should be raised by all St. Jude Medical personnel, regardless of whether they are employees and no matter their job or location. The company strictly prohibits retaliation against anyone who, in good faith, reports possible misconduct, asks a legitimate question or cooperates in an investigation.

In addition to support from in-person resources such as department managers, supervisors or legal and human resource representatives, St. Jude Medical has established a Business Integrity HelpCenter. The HelpCenter includes telephone and online options for reporting potential misconduct or asking questions and is available 24 hours a day, with access to translators who can collectively communicate in over 150 languages. The Business Integrity HelpCenter is also available to contractors, distributors, independent sales representatives and other external stakeholders.

View the St. Jude Medical Code of Business Conduct or visit the St. Jude Medical Business Integrity HelpCenter.

AdvaMed Code of Ethics Supporter badge and MedTech Europe logo

AdvaMed and MedTech Europe

St. Jude Medical is a member of the Advanced Medical Technology Association (AdvaMed), the world’s largest medical technology association. AdvaMed advocates for a legal, regulatory and economic climate that advances global health care by assuring that patients have access to the benefits of medical technology. In the U.S., St. Jude Medical supports the AdvaMed Code of Ethics. Outside the U.S., the company supports numerous industry codes of ethics, including MedTech Europe. As a supporter of the AdvaMed Code of Ethics, St. Jude Medical is certified to follow the AdvaMed Code of Ethics on interactions with health care professionals to ensure a high standard of ethical conduct.

Relationships with Health Care Professionals

Given the innovative nature of medical devices, it is essential that St. Jude Medical, like other medical technology companies, collaborate with health care professionals. Our work together draws from their experience, expertise and feedback to improve products, develop new therapies, provide training and education, and continue to advance technology and the practice of medicine.

We support transparency in financial relationships among manufacturers, health care providers and teaching hospitals. Adhering to applicable policies and maintaining high ethical standards are critical elements of these relationships. Accordingly, St. Jude Medical has adopted policies and procedures to ensure that we collaborate appropriately.

To further guide behavior regarding daily interactions with health care professionals, St. Jude Medical has implemented a health care compliance program that includes the following:

  • Dedicated health care compliance personnel at a senior level to provide program structure and oversight and at the business level to ensure day-to-day implementation and program management.
  • Policies and procedures that define appropriate relationships with health care professionals, which range from business meals to consulting relationships to educational outreach programs.
  • Education and training for employees who interact with health care professionals.
  • An established Global St. Jude Medical Compliance Committee with membership including internal compliance professionals that convenes regularly to address compliance issues and drive compliance initiatives.
  • Access to the Business Integrity HelpCenter so employees, associates and stakeholders can ask questions, submit data and report actual or perceived misconduct.
  • Continued efforts to monitor, enforce and audit the compliance program; taking corrective action as appropriate.
  • Full compliance with the Centers for Medicare & Medicaid Services (CMS) reporting requirements for physician open payments.

Training Initiatives

St. Jude Medical educates and trains health care professionals committed to specialties that align with our company’s key disease state areas. We do this by creating the premier program for future generations to define how to optimize outcomes for patients with current, evolutionary and revolutionary technologies. With physicians, health care administrators and payers we collaborate to establish new standards of care and find cost-effective solutions to today’s health care challenges.

Advanced Technology Centers

St. Jude Medical Advanced Technology Center for physician training

St. Jude Medical's unique Advanced Technology Centers (ATCs) have been vital as we pursue new ideas in treatments that improve the lives of patients. These centers are designed to provide customized and true-to-life training experiences for physicians as we work together to improve patient outcomes through the adoption of innovative and cost-effective technologies. Customer engagement at the ATCs includes didactic lectures, peer-to-peer education and hands-on simulation for clinicians.

At the ATCs, hospital administrators have the opportunity to learn about improving clinical and business efficiencies across the cardiovascular and neuromodulation care specialties. Our own employees also benefit from clinical and technical training within the ATC environment, preparing them to be a clinically competent resource for physicians and associated health care professionals.

Simulator Training

St. Jude Medical values the benefit of simulation to reinforce skill-based education on the safe and effective use of our technologies. The simulator mirrors much of what a physician would encounter during a typical procedure, such as the need to use X-ray or mapping technology, and helps train physicians to support various procedures that treat expensive epidemic diseases such as heart failure, abnormal heart rhythms or coronary artery disease. This simulation-based training is available both via a stationary model in our ATCs as well as with mobile units that are portable and can be used onsite at hospitals throughout the world. This saves physicians from traveling and allows them to focus their time on what matters most—patient care.

Privacy and Information Security

St. Jude Medical takes a proactive approach to protecting the security of our devices and privacy of confidential personal data.

We will remain vigilant to potential security vulnerabilities of our products and data in light of ever-increasing technological sophistication. St. Jude Medical performs security testing on our medical devices and networked equipment. We continually assess our investments in people, process and technology to protect patient data, our medical devices and the company’s intellectual property and business information.

Given the dynamic and changing nature of cybersecurity, we also partner with experts, others in the industry and regulators, to develop appropriate safeguards for our data and devices. These alliances with security specialists help to make medical devices safe and serve the intended purpose of saving lives.

In our commitment to secure data, our Merlin.net™ Patient Care Network (PCN) is certified globally to meet security standards. This technology gives medical professionals access to cardiac information for patients with St. Jude Medical™ implanted devices. While device information is mainly uploaded via our wireless transmitters, the system also allows patient device data to be uploaded and viewed by clinicians via a web interface accessed securely through the Internet and a compatible browser.

We respect and protect personally identifiable information that we collect and maintain. As part of our commitment, our company works to ensure that all data transfers to the U.S. from the European Union and Switzerland are appropriate and allowed under applicable laws, regulations, certifications, contractual agreements and consent forms. This policy describes the principles we follow with respect to transfers of personal information of our employees, customers and patients. Learn more about the European Union Data Processing and Transfer Policy.

St. Jude Medical is certified by the U.S.-European Union Framework and U.S.-Swiss Safe Harbor Framework agreements for Merlin.net personal patient information. This certification demonstrates St. Jude Medical’s ongoing commitment to satisfying the EU and Swiss law requirements for adequate protection of personal information transferred from the EU and Switzerland to the U.S. The certification includes yearly audits and an annual renewal. St. Jude Medical continues to work with the Department of Commerce, Federal Trade Commission and the European Directive 95/46/EC frameworks for adherence for onward transfer of sensitive personal employee information and clinical trial data.

In addition, Merlin.net PCN has an ISO/IEC 27001:2013 certification, a stringent worldwide information security standard. Merlin.net PCN is also the only telemedicine device located outside of France to be granted approval by the French governing body of ASIP Santé/CNIL.

Inquiries about the security of our medical devices or confidential patient data can be directed to St. Jude Medical Product Security