Based on experience in emergency/intensive care and equally within the medical device industry, we have learned that some companies have difficulties to clearly define the circumstances where the devices are intended to be used. It is common that same type of device can be used in a multitude of different environments.

So why does this matter? And how can you design the sound level in a device that is used in an X-ray lab, ambulance or in a helicopter? Well, two very simple examples are the type and level of the alarm sound.

The standard IEC 60601-1-8:2006 specifies basic safety and essential performance requirements for alarm systems in medical devices. However, the level of the sound is not defined except for that the high priority alarms shall be louder than the medium priority alarms which shall be louder than the low priority alarms. Interestingly there is no requirement that the sound must be at the same frequency note beeping repeatedly. Yet, that is how most of the medical devices alarm sounds.

We have had requirements for usability testing since 2007 when the first IEC 62366 was released. In February 2016, the FDA also released the guidance, Applying Human Factors and Usability Engineering to Medical Devices. Together with ISO 14971 on risk this has meant a great step forward to avoid use errors.
But still, manufacturers have difficulties taking into consideration the ecosystem of the environment of use.
Here is an example of the sound chaos a regular day at ICU.
Firstly, you have patient monitors where around six different parameters with alarms can be monitored. A patient that are ventilated through a respirator generate further 3-5 different alarm issues. Added to this, it can be around eight to ten active infusion pumps in the room. All the devices have at least low and high priority alarms. That means that at any given time you can have up to 1-20 alarm sounds to react to, and all the alarms go beep beep beep. This may actually lead to alarm fatigue for health staff and induces unnecessary stress for both the patient and the staff. What may happen is that some of the alarms are just silenced repeatedly because the staff has other priority tasks to perform. The alarm may therefore not mitigate risks as it was intended by the manufacturer from the beginning.

A study conducted in Hamilton, Ontario Canada, published in the British Journal of Anesthesia, has showed that musical notes are less stressful than standard flat notes but equally informative. One could even imagine that each type of medical device has its own melody thereby allowing the staff to immediately hear and identify which device needs immediate attention, or not. But also, to better adapt the sufficient sound level, depending on the environment where the device is used. Despite this, manufacturers continue to use flat tone beeps. The reason for this is probably economics. The time and cost to design a system that could produce melodies would probably be higher. But maybe it is time for manufacturers and regulators alike to take the next step in alarm sound design and use sound researcher expertise to find the BEST sounds, not just the most common ones, and sometimes also the most annoying ones.

Want to come in contact with us at QAdvis, just send an email to info@qadvis.com

Having dual sourcing of important components causes additional work, takes more time and negotiation price could be less successful with half the volumes.

If you add this to the fact that you also double your suppliers with additional supplier control, validations and possible Notified Body involvement, the natural question would be: Why on earth would I do this?

The simple answer to this question is risk management.

With the situation in the world right now, procuring components, especially electronic components could be difficult. And as a medical device manufacturer you cannot change components at a whim.

Change control and verifications demand time as well as resources. Also, the fact that everything is “just in time” these days means that if your single supplier runs into problems, delays can quickly become severe problems. Another scenario would be that the supplier ceases operations entirely for some reason. What do you do then? How much of the components do you have in stock before you run out? This is especially a problem if you outsource parts of the manufacturing itself or buy finished parts to be included in your device.

A real-life scenario was when a critical supplier who manufactured complicated parts to the legal manufacturer suffered a major natural disaster causing the entire production to be halted for more than a year. That caused a huge setback when all shipment of devices was halted once the stock ran out.

So, for components or details that cannot be easily replaced, a second supplier can be a good idea. Also, for price negotiations it can be a good thing to be able to match the prices between two suppliers. If delays or if serious problems occur at one manufacturer, this could be more efficiently handled if you already have a replacement.

The most difficult part is probably to sell in the idea to the management team since it will add costs. Especially if you haven’t had any problems so far. But even though you never had a fire at home, you still continue to pay your home insurance.

So, plan ahead and make your disaster management process include the risk of catastrophic events not only on your site, but also at critical suppliers.

What will you do? What level of safety do you need? It all depends on the criticality of the components you require, and the risks associated with it.

If you would like to know more or if you need guidance, contact us at info@qadvis.com or annelie.hagstrom@qadvis.com