Sterling Medical Devices & RBC Medical Innovations are combining to create Vantage MedTech! Meet RBC
Contact Us
Close Form

Interested in learning more about how we can work together in your current or next medical device design project?

Just fill out this form and we’ll be in touch!

  • This field is for validation purposes and should be left unchanged.

Wherever you are in your product development lifecycle,
Sterling can help.

P: 201-877-5682
F: 201-301-9169
info@sterlingmedicaldevices.com

Hazard Analysis

Author: Dan Sterling | Date: February 7, 2018 | Updated on December 1, 2022

What is a Hazard Analysis for a Medical Device?

Medical device hazard analysis is a fundamental requirement of ISO 14971 risk management. The steps in conducting a hazard analysis entail identifying hazards from possible occurrences or “hazardous effects.” These hazardous events could stem from the environment or usability of the device from human factors. After an assessment of the possible failures in the product or “causes” included on your hazard analysis checklist, you should take steps to do a comparison of the risks’ costs to their benefits. This is known as a “top-down” approach that reviews the component of the product at the end.

In the case the cost is greater than maintaining a residual risk— you must take actions to mitigate or eliminate this risk. In the case the benefit is greater than perceived cost— you should take actions to ensure that stakeholders are aware of the residual risks that they are being exposed to during use, why they are necessary to the medical device, and how they should be handled. There are two major co-dependent factors used in determining whether the risks the medical device poses are acceptable. On one axis, there is the probability of the hazardous event’s occurrence, or the likelihood of this event happening. On the other axis, there is the evaluation of the severity of the event, or how risky the consequences are.

What is the Hazard Analysis Method in Medical Device Development?

There are different types of hazard analysis in medical device development. The most common approaches to top-down hazard analysis include Fault Tree Analysis (FTA) and Hazard Analysis and Critical Control Point (HACCP). The two are similar in approach, but visually FTA is seen as a convenient way to estimate probabilities of frequency. At the top of the tree lies the hazardous event that poses a risk, which then branches down to various levels of factors that cause this event to happen that need to be addressed. This method is based on creating logic gates for each causation event or gates to see which are necessary to make the top-level event occur.

In the initial steps of development, it can be difficult to know specific hazardous events that might occur, but there are still high-cost baseline hazardous events that could pose risk during development that must be considered. This is useful for determining the best course of action when selecting materials, developing monitors, controls, and other design features for the product. FTA is primarily risks of various alternatives.

HACCP has a specific seven step process in structuring the hazard analysis. In addition to identification, HACCP targets critical points and limits. Once done, a specific system is established to monitor these critical control points and verify that the HACCP system is working effectively while establishing a record-keeping system.

The same perspective is applied throughout the intricacies of production to post-production of medical devices to ensure there are considerations for life threatening risks from malfunctions and misinformation. Often a risk matrix will be created with the probability of occurrence, set in relativity to severity based on the company’s risk-acceptability criteria. The result is a constantly improving and low-cost product.

At Sterling Medical Devices, we know what should be included in a hazard analysis and embed it with our human factors engineering process. To learn more about our human factors engineering, visit here.

Share this!

Contact Us

  • This field is for validation purposes and should be left unchanged.

Resources

Doctors hands showed FDA approval sign

February 9, 2023

Unlocking the Mystery of Premarket Approvals (PMAs) and 510(k)s

Are you a medical device developer with questions about when and how to file for regulatory approval? Navigating the complexities of the FDA premarket approval process can be daunting. But it...
Read More >
View More Blogs

February 18, 2021

5 Mistakes Medical Device Startups Make

Startups are the lifeblood of medical device innovation. Without universities researching ways to solve pressing healthcare problems or doctors with experience in a particular field who have an idea to develop a prototype medical device that could help patients, the future technologies needed to help save lives wouldn't happen. But the long, arduous road through the FDA submission process to get market approval can take a long time and cost a lot of money without help. Sterling Medical Devices has been helping startups through the FDA approval process since 1998 without ever having a submission rejected.
Read More >
View More Videos

July 12, 2022

Scalp Cooling System

Overview Paxman has been pioneering scalp cooling technology for over a quarter of a century. Paxman’s clinically proven cold cap technology has helped over 100,000 cancer patients in more than 60...
Read More >
View More Case Studies

Need help with your medical device?

Let Sterling Medical Devices show how to bring your idea from concept to prototype to
FDA/CE approval with a free custom project analysis.
Request Free Analysis