As a test laboratory for medical devices, our purpose is to help device manufacturers along their journey toward regulatory compliance. Due to the all-consuming nature of designing a brand new product, developers are frequently more focused on functionality than risk.

This is perfectly normal considering the long process between conception and clinical trial. However, safety is the dominant priority of medical device regulations and compliance, and therefore should not be understated. In fact, overlooked risks can turn into compliance roadblocks, so prudent developers should embrace risk early and often.

An important early step in understanding your testing needs and preparing for compliance is a thorough risk assessment of your developmental medical device.

Like many challenges common throughout the med-tech sector, there are recognized standards to rely on. For risk management, the universal standard is ISO 14971:2007 (medical devices – application of risk management to medical devices).

One convenience of embracing risk is that it stems directly from the functional aspects of the device. One of the first steps in a risk assessment is defining the intended use of the product. This is generally quite simple because the intended use has been visualized in the mind’s eye long before it is formally documented. The next step is to take the intended use and extract the potential hazards. Each hazard is to be analyzed according to its risk.

Hazardous risk has two main components:

  • The probability that the medical device will cause harm
  • The severity of that potential harm

Determining these two components—probability and severity—will produce an estimate for the overall risk of each hazard. Grading systems vary but one common example is the three-tiered LOW RISK—MEDIUM RISK—HIGH RISK. The level of risk will determine the type and rigor of response to that hazard.

Risk also needs to be factored into product packaging. A medical device may carry a risk to the patient if it arrives to the physician in a damaged condition. Moreover, even aesthetic damage to packaging can be enough to induce doubt about a product’s safety and efficacy. This is not only a safety risk but a business risk as well. Therefore, a risk management approach should be applied to all areas of a device’s development, including the box (or pouch) it’s housed in.

Where does testing fit in?

Fortunately, because many hazards are common across medical devices, there are a multitude of internationally recognized standards that delineate the best test methods for demonstrating that a product is safe for use. Each test corresponds to a hazard, frequently a hazard that has been identified as a particular issue for that type of device. Product recalls are major examples of how hazards are identified in the industry.

From a safety and compliance point of view, if a manufacturer thinks of its product’s various hazards as a list, then much of the test plan will be a documented list of tests for proving that those hazardous risks have been properly mitigated. In cases where there is no corresponding standard, risks should be controlled through other means. The end product is a coherent and navigable blueprint for the potential dangers posed by the product, and a responsive plan for managing risk. Developing this plan will undoubtedly help identify testing needs and facilitate the journey toward regulatory compliance.

At STERIS, our testing and advisory support services are informed by fundamental engineering practices, including risk management. We understand that a risk assessment is a critical component of your technical file, and view them with an eye for quality, compliance, and completeness.

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