Product Health, Safety
Edwards Lifesciences’ work to maintain Product Health, Safety and Quality supports our Aspiration to Excel as a Trusted Partner and Global Leader Through the Quality of Our Work.
High quality products are a core part of Edwards Lifesciences’ commitment to be a trusted partner to our patients. We hold ourselves accountable for developing products that enable patients to enjoy a long, healthy and happy life.
Regulatory Compliance for Quality
As a medical technology company, Edwards must comply with strict regulations regarding the design, development, manufacture and distribution of our products and services. These include U.S. Food and Drug Administration (FDA) regulations as well as those set by international regulatory bodies. We undergo frequent audits by these agencies to confirm compliance with all applicable standards.
Edwards has established a Quality System as defined in our Corporate Quality Manual. This ensures Edwards’ products and services satisfy customer requirements while complying with regulatory requirements. Our Quality System ensures we meet the regulatory requirements of the countries in which Edwards products are sold. These include, but are not limited to, the following:
- ISO 13485:2003 Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes
- ISO 14971:2007 Application of Risk Management to Medical Devices
- US Food, Drug and Cosmetic Act:
- 21 CFR part 11 – Electronic Records; Electronic Signatures
- 21 CFR part 820 – Quality System Regulations
- 21 CFR part 210/211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
- 93/42/EEC, 2003/32/EC European Medical Device Directive (MDD)
- Canadian Medical Device Regulations (CMDR)
- Japan Pharmaceutical Affairs Law, 2005 (PAL)
- Australian Therapeutic Goods Act 1989 and associated regulations
Not all requirements of the regulations are explicitly stated in Edwards’ Corporate Quality Manual. However, the intent of our Quality System is to ensure all requirements of these regulations are met where applicable.
Internal Quality Controls
An Edwards Management Representative with executive responsibility is responsible for the development, implementation and maintenance of our Quality System. The system is integral to how we operate and is implemented and maintained at all levels of our organization.
The Management Representative conducts quarterly reviews with the Executive Leadership Team to apprise them of significant quality issues, and periodically reports on quality to the Board of Directors. The reviews address opportunities to improve Edwards’ Quality System, policy and objectives. These ongoing assessment activities empower Edwards’ Quality Leadership Team to implement changes and mandate corrective action.
Quality and Supply Chain Management
Edwards insists on quality and safety at every stage of the supply chain. We align our supply chain and product quality departments, creating an open channel for partnership with suppliers in managing risk and improving controls.
Our supplier partnerships are essential in delivering the quality products that drive Edwards’ success. We evaluate and select suppliers based on their ability to meet our quality requirements. We ensure that purchased raw materials, components and products conform to our specifications and monitor key supplier performance. When needed, we take appropriate corrective action to resolve supplier-related issues. Edwards also proactively engages with suppliers to establish and execute against appropriate qualification requirements for all purchased components.
Our global product complaint handling system collects, analyzes and manages customer feedback regarding Edwards products. All Edwards’ employees must report complaints within 48 hours of receipt and receive ongoing education about their reporting responsibilities. We assess all feedback with the aim of continually improving our products to meet customer and patient needs.
Managing Product Recalls
Edwards’ Quality System is based on the transfer of strong design and development work into manufacturing. We monitor post-market product performance and manage a feedback loop to continually make product improvements. If one of our products fails to meet safety or regulatory requirements, a cross-functional team performs an in-depth assessment to determine the need for a Field Corrective Action. This team includes the Corporate Vice President of Quality, Regulatory and Clinical, the Vice President of Product Safety (a former Cardio-thoracic Surgeon), our head of Compliance and the Quality Management Representative of the affected business unit.
If a Field Corrective Action is deemed necessary, the Vice President of Quality for the impacted unit is responsible for promptly executing this action to ensure all affected products are remediated appropriately. In addition, we have systems in place to ensure that all necessary actions are taken to correct and prevent the reoccurrence of the issue.
In the U.S., the FDA categorizes recalls into three classes.
- Class I: Reasonable probability that the use of the product will cause severe adverse health consequences or death
- Class II: Use of the product may cause temporary or medically reversible adverse health consequences
- Class III: Use of the product is not likely to cause adverse health consequences
Within the European Union, manufacturers must inform the National Competent Authoriti(es) of any action taken to reduce risk of death or serious deterioration in health associated with the use of a medical device already on the market. This takes place through a Field Safety Notice.
Edwards is committed to resolving any recall issues by following regulations of the markets/countries impacted and using our expertise in quality management to implement required actions.
Edwards Lifesciences’ performance highlights our relentless focus on managing and improving our quality control systems. In 2015, we reported no Class I recalls in the United States. We provide complete information on recalls through the Food and Drug Administration’s publicly available database for medical device recalls.
Improving Patient Safety Through Device Tracking
The U.S. Food and Drug Administration (FDA) has established a unique device identification (UDI) system that will enable better tracking of medical devices. Using UDI numbers reduces the chance of patient impacts that can occur when a customer misidentifies a product. Edwards is implementing this system within our processes and our timeline is aligned with the FDA’s schedule for implementation.
In 2015, Edwards Lifesciences received FDA approval for use of our SAPIEN 3 heart valve in the United States. We designed the SAPIEN 3 for transcatheter aortic valve replacement (TAVR), an innovative and minimally invasive procedure. Clinical trials have shown that TAVR reduces patient risk of mortality and other post-operation complications.1