Team diversity helps boost competence in risk management

Insights from a Let's Talk Risk! conversation with Rene Drost

Note: this article highlights key insights gained from a conversation with Rene Drost as part of the Let’s Talk Risk! with Dr. Naveen Agarwal series on LinkedIn. Listen to the full recording of the discussion below.

One of the most challenging aspects of risk analysis is identification of reasonably foreseeable misuse¹. We struggle to figure out what type of misuse might be reasonable, and what might be foreseeable, because human behavior often is neither reasonable nor predictable!

That is where team diversity can be very powerful. When we include diverse viewpoints and life experiences in our analysis, we benefit from our collective insights. A diverse team helps us consider a much broader range of foreseeable circumstances than a team of individuals with very similar background.

This insight emerged from our discussion in the context of a recent Class I recall² of readers used with a very popular brand of continuous glucose monitors (CGM). These readers use rechargeable lithium-ion batteries that can overheat and catch fire if not properly stored or charged with a different USB cable or power adapter than that provided by the manufacturer.

On the surface, this seems both reasonable and foreseeable. After all, we use many electronic devices in our daily lives that can be charged using a USB port and any standard cable/adapter. We don’t have specially designed cables and adapters for each device.

In hindsight, it is very easy to say that the engineers should have anticipated this situation and designed safeguards in the reader. But engineers don’t always have a full understanding of consumer behavior. They design a product for optimum performance against requirements, which almost always require many trade-offs.

The gap is in the process of establishing requirements, not in the design and development process. Risks related to all potential hazards, including those arising from reasonably foreseeable misuse, should be considered prior to establishing design requirement. That is where team diversity can help.

Here are a few key points that emerged from our discussion:

1. We can learn from case studies of recalls and warning letters linked to other medical devices to broaden our understanding of reasonably foreseeable misuse. We should also use information gathered from post-market surveillance and feed it back into the design process.

2. Rechargeable lithium-ion batteries are now routinely used in medical devices, including high-risk implantable devices. Battery safety is an important topic for risk management.

3. Battery safety regulations are still evolving. FDA has recognized IEC 62133³ as a voluntary consensus standard for battery safety in medical devices. A new battery regulation in the European Union is now in effect⁴. However, there is no standalone battery safety standard applicable to medical devices at the current time.

4. A culture of collaboration helps us by including diverse viewpoints in the decision making process. By empowering everyone on the team to contribute their unique perspective, we can be more robust in our risk analysis and risk controls. Understanding and communicating risks, especially early in the design and development process before design requirements are finalized is very important.

5. We should keep the end user in mind when sending out safety communications following a recall. Patients and doctors are not legal professionals. If we use a lot of legal language in our communications, they may not fully understand the actions we want them to take for safe use of our devices. This is even more important when the patient is in the home environment where complex and confusing language may cause them to stop using a device or continue using it in an unsafe way.

About Rene Drost

Rene Drost is currently the senior executive at NAMCO Healthcare Technology, a globally operating knowledge company specialized in maintenance and operations in the healthcare sector. He started his career as a technical officer in the Netherlands AirForce, and later moved to KLM as the head of their maintenance unit. He also manages FSCA.com for vigilance and post market surveillance activities and serves as the PRRC and ISO 13485/27001 lead auditor.

About Let’s Talk Risk! with Dr. Naveen Agarwal

Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.

Disclaimer

Information and insights presented in this article are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.

1. Clause 5.2 of ISO 14971:2019 requires medical device manufacturers to document reasonably foreseeable misuse. Reasonably foreseeable misuse is defined in item 3.15 as use of a product or system in a way not intended by the manufacturer, but which can result from readily predictable human behavior.

2. FDA: Class I recall of readers used with FreeStyle Libre, FreeStyle Libre 14 day and FreeStyle Libre 2 Flash glucose monitoring systems for risk of extreme heat and fire

3. See FDA recognized consensus standards database entry, recognition number 19-33

4. See EU regulation 2023/1542 concerning batteries and waste batteries.