IEC 80001-1 PDF

IEC was published in and is now undergoing revision. Feedback gathered on the adoption of the standard has revealed a number of barriers that. recognizes that medical devices are incorporated into IT-networks to achieve desirable benefits (for example, interoperability), defines the roles. This standard was approved by the Association for the Advancement of Medical Instrumentation (AAMI) in as ANSI/AAMI/IEC and is titled.

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While the first day of the U. Published on January 14, Roles, Responsibilities, and Activities. As with any standard, much is lost to the reader of the final document who was not involved in the development process. Although the standard itself is one of the shorter consensus standards at only 42 pages, we can still only discuss highlights in a magazine article.

As such, this article will discuss the major points intheir importance to the reader, and, as much as practical, explain some of the intent behind them. To all of us, will mean some amount of confusion; about the best way to implement it, learning how to achieve goals with your co-workers that may appear at first glance to be both counterintuitive and counterproductive, and all those other things you expect from a new initiative. Since confusion typically decreases efficiency, it is reasonable to expect that institutions that embrace the risk management process will see the benefits of implementation far faster than those institutions that struggle with the new process.

We have all seen to some degree all the elements of We work with them every day. The difference now is in the context. In the past, the old context, we would connect medical systems to the IT network and transport data as part of an ancillary function, such as sending it to a database external to the medical system. If the IT network failed, the medical system continued to function properly and there was no harm.

From now on, in the new context, we integrate the medical system with the IT network and expect the IT network to support some primary function of the medical system, such as delivering medical data to a caregiver in a timely and accurate fashion, to an arrhythmia analysis computer, central nursing station, or even a wireless device carried by the clinician. In other words, the IT network becomes an integral part of the medical system and is no longer a desirable, nice-to-have feature, but a required, critical component.

First, however, it establishes a common framework by defining several terms and roles. The responsible organization is, quite simply, the entity accountable for the use and maintenance of a medical IT network. The responsible organization is, therefore, responsible for ensuring the key properties of the medical IT network are achieved and maintained. The key properties are, as mentioned earlier, the three risk components to be managed: According to the standard, there are only two types of networks: The definition of a medical device is nearly identical to that used by the FDA, which is particularly important since virtually all health care institutions already have medical devices connected to their networks in the form of PACS, imaging systems, blood bank equipment, clinical laboratory devices, and clinical monitoring devices, to name a few.

In other words, it is almost certain your facility already has a medical IT network as defined by While some might despair this puts them behind on the learning curve, in reality it provides you with a known example of a medical IT network with relatively low risk. As you begin implementation of in your facility, you can use these devices to establish a working model and gauge the effectiveness of the risk management methodologies of It is highly likely those methods found effective for these simple, legacy systems will also work on more complicated implementations or, at the very least, indicate the proper direction to take in managing newly identified risks and more complicated medical IT network combinations.


For to be successful, the responsible organization must allocate proper resources to the task. These policies help determine acceptable risks, ensure provision of resources, and identify qualified individuals required to fulfill risk management activities. Top management is also responsible for periodically reviewing the results of risk management activities and ensuring continued suitability and effectiveness of the risk management process toward achieving the key kec.

The risk management process requires a great deal of information from a variety of sources. Top management is also charged with identifying the appropriate people responsible for various tasks and ensuring their cooperation with the 800001-1 IT network risk manager MITN risk manager. These tasks are 880001-1, but include the following themes:. This includes adequately 800011-1 these individuals about their responsibility according toincluding their responsibility for maintaining the effectiveness of all risk management activities.

From the list of ice for top management to accomplish, it becomes readily apparent that of the many resources needed in managing risks for a medical IT network, the most important is the MITN risk manager.

We will return to these last two shortly. Top management appoints the MITN risk manager, based on qualifications, knowledge, and competence for risk management, and can be either an internal or external resource. We have identified the stakeholders, if not explicitly by title, at least by the various required functions and expertise needed to perform the proper management of risks. Let us now turn to the work at hand to be performed by this 800001-1 group. There are three primary sources for this information: The types of information required begin to inform the reader of the task at hand.

Medical device manufacturers have long been solely responsible for risks associated with the design and production of their devices. Consequent to their required regulatory review by the FDA, they must fully document their activities, design choices, and reasoning, then store this information in a medical device history file.

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The responsible organization must now replicate for lec medical IT network much of the activity previously performed by the medical device manufacturer—that being the risk management process concerning documenting activities, design choices, and reasoning used to create and operate the medical IT network.

For the responsible organization, this information is stored in the medical Kec risk management file. Other providers of information technology must also now accept some of the risks 80001-1 they market their equipment, software, or services as suitable for supporting a medical IT network and are likewise expected to provide pertinent information to the responsible organization.

Although provides separate lists of information considered to be accompanying documents for both medical device manufacturers and other providers of information technology, there are common themes. The general purpose of the lists is for all vendors to provide instructions and information necessary to ensure the safe and effective use of the medical device.

This includes, but is not limited to:. Once the appropriate information is gathered from the vendors and internal staff, the risk management process can truly begin. The responsible organization begins by documenting its knowledge of the devices and systems to be used in constructing the medical IT network.

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Risk-relevant asset descriptions are produced to identify hardware, software, data, and other assets, as well as their characteristics deemed to be essential to the intended use of the medical device and medical IT network. All this information is then used in the risk management process, which generates further information used to validate, support, and document decisions during the risk analysis, risk evaluation, risk control, residual risk evaluation, and change-release management processes.


For each of these risk management activities, all decisions and their rationale are 800001-1 in the medical IT network risk management file.

During risk analysis, available information and data are used to identify hazards to the key properties and estimate associated risks and probability of occurrence of harm. For any instance where the probability of occurrence of harm cannot be determined, the possible consequences shall be considered for risk evaluation and risk control.

Risk evaluation is performed to determine if risks are so low that further reduction in the risk is not needed, or if the risks are not acceptable.

If the risks are deemed not kec, risk control measures must be applied. Risk control measures are applied using any or all of three options. They are, in the priority order listed: Changes must frequently be made to systems in order to manage risks associated with new functionality.

Any changes made to the medical IT network, whether for normal support of the network or to meet risk control criteria, must be accomplished via a change management and configuration management process. These management processes themselves must include risk management. Risk management of the live medical IT network must be performed throughout its life cycle by monitoring and event management activities.

Monitoring consists of observing the medical IT network for emerging risks, effectiveness of risk control measures, and accuracy of original estimations of risk. Event management is used to capture and document negative events, propose changes, track corrective and preventive measures, and report significant findings to the MITN risk manager. During the entire life cycle of the medical IT network, 800001-1 medical IT network risk management file is used to contain all documentation pertinent to the medical IT network and decisions regarding it.

This file does not necessarily represent a single physical location where all information is stored. The file may contain physical information or pointers to the locations of other information stores. We hope this high-level overview of IEC 80001-1 helpful.

As mentioned earlier, detailed coverage is near impossible in a single magazine article. Also, remember that was designed to allow the responsible organization some flexibility to meet needs that are unique to it. Further guidance will come from a set of technical reports iiec under development. Rick Hampton is the wireless communications manager, Partners HealthCare System, Boston; and Rick Schrenker ifc a systems engineering manager, department of biomedical engineering, Massachusetts General Hospital, Boston.

For more information, contact. Please provide your name and email to continue. By using this site, iiec are accepting our terms and conditions. Ultrasound Systems and Probes If the buzz at the recent RSNA annual meeting is iev indication of market trends, the ultrasound sector is hotter…. The three risk iwc to be ieec, in order of priority, are safety, effectiveness, and security. Responsible organization includes health delivery organizations of all sizes and eic just hospitals.

The responsible organization will need to work closely with medical device manufacturers and providers of other information technology. Establishing a Framework describes the functions a responsible organization must accomplish to identify, mitigate, and manage the risks associated with putting medical devices and systems on the IT network. Ensuring Risk Management Processes Top management is also responsible for periodically reviewing the results of risk management activities and ensuring continued suitability and effectiveness of the risk management process toward achieving the key properties.

800001-1 tasks are many, but include the following themes: Gathering, analysis, assessment, and storage of information needed for risk management; Choice of, procurement, maintenance, technical support, life-cycle management, and use of medical devices; Maintenance of medical IT networks; Reviewing and accepting residual risk on behalf of top management; and, Management responsibilities for medical IT networks and general IT activities.

This includes, but is not limited to: