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Risk Management (ISO 14971)

Risk Management

Almost no business, whether it is a local grocer selling to a handful of customers or a multinational spread across the globe, is exempt from risk management. This should be one of the most used and most important terms in a business. There is every reason to believe that risk is as inherent to business as perhaps carbon dioxide is to the atmosphere. Carbon dioxide may not be required for us humans, but is an unavoidable byproduct of our bodies, just as risk may not be desirable, but is unavoidable. In simple terms, one could say that in a business, a risk is a necessary and inescapable offshoot.

Risk can be mitigated, not done away with

We have seen that risk is simply inseparable from a business. This means that risk is so closely related to business that the two can probably not exist in isolation of each other. Since it conceded that risk can only be controlled or managed and not eliminated; a business has to devise ways by which it can do this. This is what risk management essentially is about. The success of a business depends in large part on the way it carries out risk management.

Risk management and the medical devices industry

Any manufacturing process carries with a certain risk. It terms of gravity, this can vary in proportion to the task, but to reiterate what has been said till now; risk is inevitable. How does risk impact the medical devices industry, and what does risk management in the medical devices industry entail?

Any medical device is subject to a high degree of scientific processes and supervisions. They carry with them both uses and risks. When a medical device’s risk exceeds its intended benefits; it can mean great danger for the patient. Keeping in view the extreme importance of risk management in medical devices; the International Organization for Standardization (ISO) has enacteda number of regulations that are aimed at reducing risks and increasing the effectiveness of medical devices. These are spelt out in ISO 14971:2007, which is specifically about dealing with risk management in medical devices. This standard underwent a revision in 2009.

ISO 14971

The ISO 14971 is considered the benchmark for risk in the medical devices industry. It deals extensively with risk management. The most striking feature of this regulation is that it makes risk management obligatory and to be present and demonstrated right from the device manufacturing process and lasting the entire product lifecycle. The evaluation of risk of a medical device is mandatory for the manufacturer.

This standard also requires him to specify the risk in the medical device both in relation to the impact it makes on the patient and in its interaction with other medical devices. Concomitant to the second of these requirements; ISO 14971 requires the manufacturer to share the process of manufacturing with other healthcare providers whose products the patient may be using. If for instance, the patient is using a defibrillator, the manufacturer of this device has to allow the manufacturer of other devices the patient may be using, such as human tissue for example, to share the same information about its processes, and obtain certification of the same. This makes risk management very robust and comprehensive.

Role of top management

Another of the important highlights of ISO 14971 is that it requires top management of medical device manufacturing firms to demonstrate their commitment to risk management through the following ways; a)establish the process, b) set up the policy for acceptable risk, and c) review of the effectiveness of the process/processes at preset intervals. 

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