Human factors as a factor in medical devices 2017

The ANSI/AAMI HE75:2009 document describes human factors as the way in which the elements of human knowledge, such as emotional, intellectual, and physical and the sensory are used to optimize the production of devices, systems, and many others concerned with them. Human factors take not only the ways in which these human elements are used to raise productions, but also the way in which the limitations of these factors come into play. It is a field that is essentially concerned about the interaction between humans and devices or machines.

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Given the nature of this description, it is not surprising that human factors are important to areas such as design and aesthetics. It is an important aspect of user interface. User interface has gained a lot of acceptability and popularity following the emergence of the field of IT, but it can be used in a number of other areas. Since there is almost no area of production or science in which the user does not come into the picture; human factors can be a major factor in creating and shaping user interface for a number of products.

A major factor in medical devices

In the area of medical devices, human factors come into play in a prominent way. Although, strictly speaking, medical devices are not products into which the aesthetics is considered critical in determining consumer behavior in the way it is for say, clothing; design is an indispensable factor. Design plays a very major role in the user interface of medical devices, because these products have to be designed to absolutely precise specifications. A small deviation or variation can cause harm to humans, given the nature of the uses of medical devices. Errors can result in major consequences for patients, and subsequently, to the organization manufacturing the devices.

When it comes to medical devices, the FDA has the primary responsibility of regulating them with the intention of ensuring their safety and effectiveness. Incorporating the principles of human factors into medical devices ensures that the product meets specification, design and quality standards and thus becomes faster and less expensive to market. On account of this, human factors are becoming part of the design and development, as well as of the supplementary aspects of medical devices, such as Instructions for Use, labeling and even training.

FDA’s regulations talk about human factors in medical devices

21 CFR 820.30 emphasizes that human factors need to be taken into consideration for the following:

–       Design input: Ensuring that the needs of the patient and any others who may use the product are taken into consideration

–       Design verification: Making sure that the criteria for performance set for the medical are being consistently met, and

–       Design validation: Ensuring that the device conform to predefined user needs as well as intended uses, as also making sure that testing is carried out to ensure this function. Software validation and risk analysis are part of this testing.

In addition, the FDA has also emphasized the area of human factors in medical devices in many guidance documents and a number of upcoming Draft Guidance documents.

Explore the area of human factors in medical devices

Curious about how human factors play a role in medical devices? Want to explore the area in-depth and stretch your knowledge and imagination of human factors in medical devices? A seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance will offer this learning.

The Director of this seminar is Virginia A. Lang, Principal and Founder HirLan, Inc. and HirLan International SA. Over the course of these two days, Virginia will cover all the important areas relating to human factors in medical devices. To enroll for this important learning session, just log on to

Human Factors and Predicate Combination Products. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

A complete explanation of regulations and uses of human factors in medical devices

The core aim of this seminar is to familiarize participants with the way in which human factors can be applied into medical devices. Towards covering this, she will explain all the current and upcoming human factors requirements, using which, participants will learn how to keep costs under control and reduce the time for the manufacture and marketing of their products. Those in charge of crucial functions in medical devices, such as Quality Assurance, Regulatory Affairs, Device Engineering, Device Manufacturing and Pharma/Medical Devices will gain a great deal of learning from this seminar.

Virginia will cover the following areas at this seminar:

o  Overview of Human Factors and the FDA perspective

o  Human Factors Methods and Device Product Life Cycle

o  Human Factors and Risk Analysis & Management

o  Human Factors: What Devices Require Human Factors Evaluation and Validation?

 Human Factors and Combination Products

o  Human Factors and Combination Products Submitted in an ANDA.

Applying ISO 14971 and IEC 62304 to medical device software

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Risk management of software used in medical devices has to be implemented diligently, completely and correctly, scrutinizing the gaps thoroughly and correcting them right from the very start of product development. This is critical because of the following reasons:

  1. Medical products that have gaps or are implemented incorrectly or incompletely suffer serious ailments such as impediments or delays in production. Further, such products fail to get the required certification and/or approval;
  2. Given the close linkage between most activities and the development lifecycle; almost no activity can be isolated and performed with retrospective effect after detection of a gap. As a result, all the activities performed till the identification of gaps become unproductive and redundant. When this happens, the company has to start from the beginning, irrespective of the stage at which an anomaly gets detected, incurring huge delays and cost overruns.

The solution to these problems is to embed software risk management into the bigger scope of overall risk management. This is the only real solution to problems associated with faulty product development. Globally applicable standard requirements such as ISO14971 and IEC62304 are major guidelines that help medical device companies get the risk management of software used in medical devices right. These standards have made risk management central to and a mandatory component of almost any activity in the medical device industry.

Getting it right from start till finish

Regulatory requirements set out in ISO14971 and IEC62304 standards that deal with risk management of software used in medical devices need to be implemented in the right manner, if medical device companies have to clear regulatory hurdles and meet quality standards. Expert professional trainings that help them do this will give them an understanding of how to design, implement and test critical medical device software in a regulatory compliant environment.

All these will be part of a learning session that is being organized by GlobalCompliancePanel, a very well-known provider of professional trainings for the regulatory compliance areas. This two-day, live seminar will have Markus Weber, Principal Consultant with System Safety, Inc., who specializes in safety engineering and risk management for critical medical devices, as the course Director.

To gain the benefit of expert training from the Director of this seminar; please visit http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900750?wordpress_SEO  to register.

Globally applicable standard requirements

Markus will explain the requirements set out by international consensus, reflected in globally applicable standard requirements such as ISO14971 and IEC62304, which has led to risk management being a mandatory component of almost any activity in the medical device industry.

Since the need to embed software risk management into the bigger scope of overall risk management is a critical aspect; Markus will introduce all the steps needed for designing, implementing and testing core medical device software in a regulatory compliant environment, even as they adhere to the principles of risk management. Another important learning Markus will impart is system level risk management and the resulting interfaces to software.

The safety case method

A well-established method for collecting and consolidating all safety related information together in one location, so that all risk related activities are comprehensively summarized, and the safe properties of a device demonstrated, is what is called the ‘Safety Case’ or ‘Assurance Case’ document.

Although as of now, the FDA requires this method for only infusion pump submissions; this system of documentation is almost certain to become standard practice in the future across all devices that come up for approval. At this course, Markus Weber will introduce the basic concepts and content of safety assurance cases. He will also explain and illustrate their utility for internal and external review of safety related information.

Tips for practical application of risk management principles

Real-life examples and proven tips and tricks that make the application of risk management practical and beneficial will be offered at this webinar. The Director will describe the system level issues of risk management as well as the increasingly important software related issues of critical systems.

He will introduce the concept of an assurance case to make the combined effort needed to design, implement and verify a safe device transparent. An important outcome of this learning is that it will help participants to meet and comply with regulatory requirements with highly lessened overheads and resource burdens.

Quality audits for the medical device industry

Quality management systems of medical devices have to go through well-defined quality audits. Medical device companies need to implement these in order to show compliance with quality.

ISO 13485 is the quality management standard for medical devices. Based on the process approach of this document and that of 21 CFR part 820 the Global Harmonization Task Force (GHTF) has set out processes for audits relating to the quality management systems of medical devices. The GHTF believes that insertion of quality management system requirements based on ISO 13485 is a first step towards global harmonization of medical devices. These guidelines are meant to lead regulators into articulating regulatory systems for medical devices.

Purpose of quality audits according to GHTF

The GHTF spells out the rationale for carrying out quality audits for the medical device industry. The benefits of carrying these out can be seen in the following:

  • Assurance that a high quality medical device will be made available
  • Quality audits for the medical device industry make available a harmonized, consistent standard that can be used by future generations
  • These audits are independent, verifiable and objective assessment of the manufacturer’s compliance with regulatory requirements
  • The results of these audits can serve as an important guide for marketing medical devices.

Definition of quality audit

GHTF describes the quality audit as the organizational responsibilities, processes, structure, resources and procedures taken to implement a quality management system.

What should the quality management system cover?

The QMS in a medical device organization should cover the following:

  • Control of documents
  • Control of records
  • Management review
  • Internal audits
  • Corrective and preventive action

General requirements for organizations that audit

GHTF lists a few general requirements from auditing organizations. These include:

Audit types

Apart from describing the audit scope and methodology in detail; the GHTF also has a description of the types of quality audits for the medical device industry. They are:

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