3 Tips To Ensure The Functional Safety Of Medical Devices


In the medical field, professionals use technology to aid in the delivery of complex operations. With the wide range of medical needs patients have, healthcare professionals need to adopt using a diverse set of tools.


Owing to the complexity of treatment procedures, patients have to rely on both you and these medical devices, hoping that you can use them to conduct the operation without any issue. So, to avoid medical mishaps and alleviate your patients’ worries, you must ensure your medical devices’ functional safety.

What Is Functional Safety?

The International Electrotechnical Commission (IEC) and Food and Drug Association (FDA)define functional safety as the safety standard guaranteed by all medical device manufacturers over their medical device’s ability to resolve any hazard that can potentially come up during (or before) an operation.

The Importance Of Functional Safety

Health professionals are entrusted with their patients’ lives. Therefore, patients expect medical workers to engage with manufacturers such as medical contract manufacturer RBC that remain faithful in staying up-to-date with the IEC and FDA medical device standards for both the safety of the professional and the patients. Specifically, the ‘functional’ aspect of safety involves the following:

  • Lessening risks to patient health and safety mid-operation, and
  • Remaining functional despite the occurrence of the risks

Tips To Secure Functional Safety

Many medical professionals already receive a bad reputation for being ‘too intimidating.’For instance, patients of all ages are still influenced by the many childhood horror stories their parents made up about dentists. Therefore, you should look for ways to assure your patients of their safety. To help you out, here are some ways you can ensure the functional safety of the medical devices you use and guarantee your patients that they’re in good hands:


1. Plan A Fail-Safe

Before treating a patient, it’s crucial that you gain a sense of familiarity withthe medical devices you use. For instance, by studying its design and function, you’ll be confident in using the tool during a high-stakes operation. Moreover, with greater familiarity, you can easily identify whether some of its parts are defective, which might jeopardize the operation.

Also, since you’re more familiar with the design of the medical device, you can create a risk management plan ahead of the procedure. Putting into consideration anything that might be a risk, you can already plot out damage control initiatives to maintain ahold of the situation regardless of what happens. Having a fail-safe in place to manage contingencies with ease also ascertains your professionalism, therefore giving credibility to your position as a medical practitioner.

2. Conduct Self-Tests

When handling medical devices, you should take the time to give them a test run before using them in actual medical procedures. Make it a habit to study the purpose and function of the equipment you’ll need in your practice.

Since most medical devices are specialized for certain procedures and aren’t meant for universal use, you must take into account their design. Depending on its function and design, the device may have many protective systems are already built-in that can do the work of monitoring and safeguarding the device for you. In this case, a self-test won’t be needed as much.

As for those with only one control and protective system, you should never fail to conduct a self-test. This way, you can recognize any potential or issue early on.


If you’re not sure how to identify your device’s systems, you can consult with its manufacturer or check the FDA classification database.

3. Take Note Of The Details

During the self-test, you must record everything that happens because, ideally, there should be no issues. Realistically, however, errors are bound to occur, whether it’s due to wear and tear or other technical flaws. Therefore, in case of errors in the device, you must take note of the following:

  • The Multiple Fault Occurrence Time (MFOT)
  • The Mean Time Between Failure (MTBF), and
  • The Fault Tolerance Time (FTT)

The MFOT is the length of time between two potential failures wherein the device can still be considered manageable. When the MFOT is significantly short, it might be time to replace some of the device’s components that are meant to be disposable after a specified period.

On the other hand, MTBFrefers to the span between two failures that happened consecutively. Lastly, the FTT plays an important role in identifying how long a device will remain functional until those aforementioned failures worsen to a degree where the device is already too hazardous for further use.

The Bottom Line

As efficient technology may be, you should also learn how to deal with the amount of complexity it’s associated with. And in the medical field, you should be ready to navigate through unexpected circumstances to reassure your patients of your practice and guarantee a positive experience for them. To accomplish that, ensuring your medical device is within functional safety standards is a must.


Sarah Williams

Sarah Williams is a blogger and writer who expresses her ideas and thoughts through her writings. She loves to get engaged with the readers who are seeking for informative contents on various niches over the internet. She is a featured blogger at various high authority blogs and magazines in which she shared her research and experience with the vast online community.

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