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Health Care

Why ISO 13485:2003 Is Important

Thoughts from the chair of the ISO technical committee for medical device quality management

Published: Tuesday, March 22, 2016 - 13:31

With medical devices ranging from simple needles to life-saving high-tech implants, ensuring the highest possible level of safety is one of the industry’s greatest priorities. Here, as the chair of the ISO technical committee for quality management and related general aspects for medical devices, Eamonn Hoxey, Ph.D., shares his thoughts about the industry, its exponential growth, and why uniform and consistent standards are important.

Many medical devices are invasive by nature—they probe in and around the human body. While some explore the anatomy, cut away disease, and repair damage, others remain inside the body, such as a prosthetic hip, an artery stent, a new valve, or a pacemaker.

Combining the highest-of-standard design and performance characteristics for medical devices with the complicated business model of healthcare itself—and the field’s stiff regulatory requirements—makes for one of the most complex and demanding industry sectors known for any manufactured product.

Eamonn Hoxey, Ph.D., chair of ISO technical committee ISO/TC 210, concerning quality management and corresponding general aspects for medical devices

To manage this complexity, says Hoxey, who serves as Johnson & Johnson’s vice president for medical devices strategic quality and compliance programs, ISO standards are essential. They bring quality medical devices to market and sustain them throughout their life cycles.

As chair of the ISO technical committee for ISO/TC 210, Hoxey also argues that ISO standards can support the regulatory requirements that oversee their safety and performance. In this ISOfocus interview, Hoxey talks about the latest trends in medical devices standardization, which he believes are shaping the dynamic change that is taking place in the industry.

ISOfocus: How do you determine when a medical device is safe for patient care?

Eamonn Hoxey, Ph.D.: A systematic approach to risk management is applied throughout the life cycle of a medical device. Initially, during design and development, risks to safety and performance are identified and measures are devised to eliminate or mitigate them. The design then undergoes stringent verification and validation to demonstrate the effectiveness of the risk controls that have been introduced, and to confirm that any remaining risk is acceptable when weighed against the clinical benefits. Throughout the use phase, the medical device is further monitored to determine any unidentified risks and the effectiveness of the risk controls in place, so that action can be taken if there are any unexpected events.

ISO/TC 210 has developed standards to support the regulatory requirements that oversee the safety and performance of medical devices. The design and development of these devices is part of the manufacturer’s quality management system (QMS) and ISO 13485:2003—“Medical devices—Quality management systems—Requirements for regulatory purposes” provides requirements for the design and development process, including the incorporation of risk management. In addition, the standard covers the analysis of feedback from experience during the use phase and the conducting of post-market surveillance. As an effective complement, ISO 14971 describes a systematic approach to risk management that can be applied throughout the medical deviceʼs life cycle.

ISO: To what extent do ISO standards affect the safety, quality, and reliability of our health services?

Hoxey: “Health services” is a broad term that encompasses all aspects of the delivery of healthcare to patients in a wide variety of settings—from hospital wards to laboratories, from hospital outpatients to general-practice surgeries, from home healthcare to first aid. One particular area in which ISO standards play a significant role is the life cycle of healthcare technology, from design and development through the supply chain to the point of use.

Healthcare technology is used throughout the delivery of health services in a variety of settings. Its scope is enormous and includes sophisticated diagnostic imaging and laboratory equipment, devices used in surgical procedures, aids to daily living, and equipment sold over the counter in a variety of retail settings. Healthcare technology is vital to the efficient and effective operation of healthcare delivery and contributes to changing the lives of patients and caregivers on a daily basis.

There is a wide range of ISO standards used in the life cycle of healthcare technology. ISO/TC 210 is involved in a number of general areas that span the full range of products. Examples are standards for a QMS used for regulatory purposes, risk management processes used in the life cycle of medical devices, symbols used to convey information on labels and to avoid the need for translation of critical information into multiple languages, and small-bore connectors used in combining devices to provide therapy to patients.

Knee replacement surgery, also known as knee arthroplasty, can help relieve pain and restore function in severely diseased knee joints.

ISO: Medical devices play an ever-increasing role in transforming healthcare delivery, but there is a dramatic “risk to life” angle in lack of interoperability or misconnection. Could you please elaborate?

Hoxey: Medical devices are a critical element in the safe delivery of healthcare and command a high degree of safety and performance. As the clinical environment becomes more complex and the technology more sophisticated, particularly with the interaction of multiple medical devices used on a single patient, the need to consider the total system rather than the individual components also increases.

The growing application of a systems approach and consideration of issues, such as human factors and usability, during the design and development of medical devices are accordingly becoming more important. ISO/TC 210, in conjunction with IEC/TC 62 on electrical equipment used in medical practice, has developed a number of standards that apply systematic approaches to quality management, risk management, and usability, and has in preparation a series of standards on small-bore connectors intended to reduce the risk of misconnection of devices at the patient interface.

ISO: How important is a QMS to medical devices? Why was it necessary to update ISO 13485? What will be the additional benefits of the revised version?

Hoxey: A QMS is a critical element for medical devices, required by the regulations in most jurisdictions to integrate the control of a product’s life cycle. Hence, it was necessary to update ISO 13485 to reflect the latest developments in technology as well as the expectations of manufacturers and regulators.

The main benefit of the revision will be greater transparency of the requirements and alignment between the regulators, auditing bodies, and manufacturers of medical devices. Areas that have been strengthened include the interaction between the QMS and regulatory requirements; the applicability of the standard throughout the medical device’s life cycle, for example, across distributors and importers; and the wider incorporation of risk management principles throughout the QMS.

ISO: Why is Johnson & Johnson participating in ISO standards work, and what kind of benefits does the company stand to gain?

Hoxey: Johnson & Johnson welcomes the chance to participate in standards development. It provides an opportunity to address common challenges for manufacturers, regulators, and users, and helps develop solutions that benefit all parties, ultimately for the good of the patient. In addition, there is great scope for professional development for our staff as they acquire both technical knowledge and interpersonal skills.


About The Author

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The International Organization for Standardization (ISO) is the world’s largest developer and publisher of international standards. ISO is a network of the national standards institutes of 162 countries, one member per country, with a Central Secretariat in Geneva, Switzerland, that coordinates the system. ISO is a nongovernmental organization that forms a bridge between the public and private sectors. ISO enables a consensus to be reached on solutions that meet both the requirements of business and the broader needs of society. View the ISO Standards list.