Quality and Safety: Holding Ourselves to the Highest Standards
We take quality and safety seriously, knowing that patients’ lives depend on our products. This principle guides every process we undertake, and shapes everything we build and create. This is how we meet and exceed customers’, patients’ and regulators’ expectations of quality and safety.
We continually assess the safety and performance of our products. In this rapidly changing health care environment, we also look to design processes, process controls and customer feedback so we are sure we always meet the needs of our customers and their patients.
Our quality policy
Abbott is committed to providing our patients, customers and regulators with products and services that meet or exceed their expectations of safety, high-quality performance, reliability and service.
Our commitment to quality drives every aspect of our business processes and decision-making. We foster a culture of quality everywhere we do business. This means communicating our expectations to all employees and partners, leading by example and providing formal employee training on requirements for our approach to quality management.
Abbott monitors all product life-cycle stages to assess opportunities for improvement, including: device feasibility studies, product development, clinical trials, manufacturing, marketing and promotion, storage, handling, distribution, use and service. As a medical device manufacturer, our company is subject to a variety of regulations and standards for products and quality management systems and we work to ensure that continuous improvement is built into our processes and procedures.
Product and service labeling
We are also subject to a variety of regulations and standards for products and quality management systems that ensure product labeling information, including marketing materials, is accurate and controlled. For all of our products, we employ robust labeling design processes directed at creation, review and approval of device labeling that is consistent with the applicable laws and regulations of all countries where we sell products. We strive to adhere to all applicable labeling standards and where necessary, include information regarding the sourcing of components for the safe and effective use of our products.
In support of our commitment to developing medical technology and services that contribute to successful outcomes for every patient, we have established global processes and procedures that allow customers to provide feedback. Information regarding device performance or services rendered is routinely reviewed so that customer feedback is a primary input to our continuous improvement mechanisms and to ensure that Abbott supports global regulatory medical device vigilance systems.
We take a responsible stance and seek rigorous compliance with the variety of applicable regulations and standards for products and quality management systems in an effort to ensure our marketing materials including labeling, marketing communications, advertising and promotional materials are accurate and controlled. For all of our medical technologies, we employ robust design-control processes for proper review and approval of these materials that is consistent with the laws and regulations of the countries where Abbott sells products.
Our quality performance
Abbott has a strong history of product 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.
We follow industry best practices in product failure analysis and regularly report on the performance of our products. Our bi-annual product performance report details product performance and reliability and significant physician advisories to notify physicians of new information about the safety and performance of select products.
Privacy and information security
Abbott takes the security of devices and their data very seriously. Protection of confidential patient and consumer information is a high priority for us, and we will remain vigilant to the ever-increasing sophistication of those seeking unlawful access to such data. Abbott has an ongoing program to perform security testing on our medical devices and networked equipment.
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. We continually assess our advanced processes and technology to protect patient data, our medical devices and the company’s intellectual property and business information.
Our work with a variety of firms that are experts in this area helps 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.
Inquiries about the security of our medical devices or confidential patient data can be directed to Abbott Customer Service.
Abbott Cyber Security Medical Advisory Board
On October 17, 2016, Abbott announced
the formation of the industry’s first Cyber Security Medical Advisory Board (CSMAB). The CSMAB is made up of leading physicians who are caring for patients with implanted devices. These physicians will provide direct feedback on patient management considerations.
Enhancing technology to address cyber security risks must be balanced with how to best care for patients who benefit from medical devices. The CSMAB will work with internal and external technology experts to provide their perspective on this balance between cyber security and medical device innovation.
The current CSMAB board members are:
- Leslie A. Saxon, M.D., University of Southern California (Chair)
- Kenneth A. Ellenbogen, M.D., Virginia Commonwealth University
- Andrew Epstein, M.D., University of Pennsylvania
- Laurence M. Epstein, M.D., Brigham and Women's Hospital
- Leonard I. Ganz, M.D., Heritage Valley Health
- Niraj Varma, M.D., Ph.D., FRCP, Cleveland Clinic
The CSMAB will help Abbott adapt to evolving issues over time. We anticipate that the CSMAB will assist Abbott by:
- Providing advice and counsel to Abbott concerning patient care and management and physician needs in connection with cyber security topics;
- Assisting Abbott in ensuring that the evaluation of cyber security is integrated with a holistic assessment of potential impacts on patient health, safety, and security of patient data and health information;
- Balancing patient and physician needs and clinical perspectives with cyber security throughout the product lifecycle; and
- Making recommendations to Abbott with respect to any aspects of the governing Charter as the CSMAB may deem necessary or appropriate.
We look forward to working closely with the physicians on the CSMAB to assess cyber security risks and to better understand how they may impact patient care. The CSMAB will complement other cyber security efforts at Abbott and further builds on our robust history and continued foresight in addressing cyber concerns and opportunities.