Subject: MDR and risk-based approach

We internally evaluate that action’s benefit versus the risks (or cost) for almost every action that we take. If we believe the benefits outweigh the risks, we undertake that action. Else, we don’t.
Risk management’s fundamental reason is the progressive shift in the industry where more and more decisions are risk-based. Risk-based choices are rational and defensible. In many aspects of product development, e.g., design choices or sample size determination, the risk is a good discriminator and basis for decision making. Moreover, the European Medical Device Regulation (EU MDR) prefers a risk-based approach to evaluating the manufacturer’s technical documentation and the manufacturers’ oversight and monitoring.

How can one make risk-based decisions if one doesn’t know the risks?

Risk management offers the answer.
“Risk” can mean many things. Risk implies an absence of safety and the possibility of suffering a loss. In healthcare, patient safety efforts concentrate on risks such as the risk of falling or the performance of “risky” procedures. We use timeouts to minimize the risk of wrong-side surgery. Risk is associated with potential financial loss, legal liability, or both. Yet, we also talk about risk being related to opportunity, as when we decide that something is “worth the risk.” In decision making, we frequently “weigh the risks,” including the risk of doing nothing, before choosing a course of action.

The corporate world defines risk as any factor that can jeopardize its ability to achieve its business objectives.

In practice, risk management typically involves identifying risks and minimizing them by eliminating the risks, implementing procedures to reduce the risks, educating personnel on avoiding the risks, or buying insurance to outsource the risks’ financial impact. Risk management is typically performed within a given service’s span of responsibility, at the department, unit, or division level. A threshold issue is whether such a balkanized approach to risk management is maximally practical or whether it might be preferable to address risks at the organizational level, taking advantage of economies of scale. One may counter that a local approach to risk management effectively brings risks to the attention of those with the most expertise and experience regarding risks in their spheres of activity. Also, human nature being what it is, managing risk across departmental domains may give rise to feelings that one group is criticizing another or otherwise overstepping its bounds.

The involvement of the Risk Management reviewers and stakeholders in the preparation of the Risk Analysis is essential. The collective participation enriches the analysis, but the participants’ familiarity will make the review of the Risk Management Report easier.

Risk management is a truly interdisciplinary endeavor.
The medical industry is required to evaluate the potential risks due to the use of a medical device against that device’s potential benefits. Regulatory approval of a medical device requires demonstrating that its advantages prevail over the risks of the device. Rather than making a subjective judgment, formal and systematic methods are used to make this determination.

Manufacturers are not expected to be error-free, flawless, or perfect. They are expected to use sound processes and good judgment to reduce the probability of harm to people.
A sound and properly executed risk management process does not render a risk-free medical device. It implies that the best efforts were made to produce an adequately safe device that benefits outweigh its risks. Human beings are prone to errors and poor judgment. It is called misfeasance in legal terms. It is different from malfeasance, which is deliberate or deceptive actions intended to release a not adequately safe device.
Safety risk management applies to medical devices’ entire lifecycle, including design, production, distribution, installation, use, service, maintenance, obsolescence, decommissioning, and even destruction or disposal.

Why do Risk Management?
There are many good reasons to do risk management. In addition to making safer products, risk management can help reduce design and development costs by identifying the design’s safety-critical aspects early in the product life cycle. Risk management is a legal requirement in most countries, without which it would not be possible to obtain approval for the commercialization of medical devices. In unfortunate situations when medical devices injure people, the first place that lawyers would look at is the device’s risk management file.

Cost efficiency
One of the main benefits of risk management is gaining knowledge of a medical device are; where they are, and how big they are. With this knowledge, the product development group can focus their engineering resources on the highest-risk areas. Furthermore, sound risk management practices can help detect design flaws that have a safety impact early in the product development process. The sooner a design flaw is corrected, the less expensive it is to fix it.
Another factor that medical device manufacturers face is the concept of ALAP/AFAP, or reduction of risks to as low/far as possible. Without knowing the risks of the design’s various aspects, manufacturers may go overboard and overengineer the product, particularly in the design’s low/no risk areas.

Avoiding recalls and field corrective actions
Safety violations are the main reason for product recalls and Field Corrective Actions. Product recalls are costly and expose manufacturers to lawsuits and potentially large fines, settlement costs, and legal fees. Moreover, the reputation of a manufacturer may become tarnished, and future sales hampered.
Acceptable risk management practices can reduce the probability of harming people or the environment, thus avoiding recalls.
One of the essential benefits of risk management is that it provides leading indicators for potential future problems. In many cases, a manufacturer realizes only after an adverse event that they are in trouble and facing a lawsuit or punishment by Regulatory bodies. Risk management enables manufacturers to identify the highest risks associated with their products and forecast the probability of serious adverse events.

Better communications
An unexpected side benefit of risk management is improved communication. In most companies, the product development teams become siloed, which means poor communication among the various disciplines, such as clinical engineering, mechanical engineering, sterilization, etc. Because risk management is a team effort, it tends to bring the multiple fields to the table to work together toward safer products.
One of the factors that should be kept in mind in analyzing risks is that the risk is not a deterministic outcome but rather a probabilistic phenomenon. The same therapy from a device could have different consequences for different patients. Variations in patient physiology and environmental conditions can contribute to vastly different harm severities, from patient to patient.
Before a product is launched, risk management is about predictive engineering— to forecast risks and attempt to reduce and control the risks to acceptable levels. The former contrasts with postmarket risk management, which takes the reactionary approach of root cause analysis, and Corrective and Preventive Actions after an adverse event has happened in the field.
Regardless of the product development stages and life cycle, the risk management process can be broken down into a few critical steps, with each part of the process building upon the earlier features. As with the risk management plan, the risk analysis is expected to change throughout the product development and may be updated due to postproduction feedback, changes in the regulatory requirement, or new information on the product’s hazards and risks.
Inspired by Elahi, Bijan. Safety Risk Management for Medical Devices, Elsevier Science & Technology, 2018

This newsletter is part of our campaign to increase the sensitivity and the awareness of all our business partners, to bring more clarity around the MDR journey and challenges and opportunities around the MDR Art.22 “Systems and Procedure Packs.”
We are already today all dependent on efficient cooperation. For the MDR implementation, we require even closer collaboration to ensure we all can deliver safe supply to hospitals and patients in the future.

We are confident we’ll continue to supply health care competently on customized surgical procedure sets and small kits.
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The next MDR Newsletter will be issued in March. We wish everybody pleasant days.

Augusto Orsini
CEO STS Medical Group

Katarzyna Zofia Chrusciel
Corporate Technical Director
Quality Management and Regulatory Affairs