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Medical Electronics is becoming increasingly smarter. So why we still have to care about the incident management?

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Posted March 27, 2018

The latest trend in the field of medical electronics is defined very concisely: the smarter, the better. Built on the basis of highly-reliable electronics components and run by sophisticated algorithms, modern medical equipment has extremely low failure rates and also leaves little room for human error. At first glance and to a person who is not involved directly, everything could seem ‘just fine’.

Image credit: U.S. Air Force photo by Airman 1st Class Nicole Sikorski, Public Domain

But electronics still have a possibility to fail, no matter how reliable it is. There are also other factors that have to be considered when evaluating the need for well-coordinated incident control, such as the growth of medical electronics market, possibility of human error, and the latest cyber-safety trends.

Let’s look into each of these areas in more detail.

Numbers of medical devices increase rapidly

The global medical electronics market is projected to increase in size by 5% to 8% annually over the period of next five years, depending on the forecast methodology. In simple terms, this means more devices and more users using them.

The most of this growth will result as a consequence of miniaturization of medical devices. But even with the patient-friendly interfaces and relatively safe design of such handheld or wearable equipment the likelihood of incidents of different kinds could increase, because using personal medical devices in homecare settings usually presents more risk when performing the same procedures in clinical environment.

This issue becomes even more apparent when considering the growing popularity of wearable medical and wellness-related electronics. This is why legislators in many countries are pushing for new and stricter regulatory changes for medical electronics. These regulations are planned to cover more demanding risk management processes, and therefore the demand for specialized incident management systems should also increase substantially.

Human errors still happen, and quite often

When accounting for human error, the level of ‘smartness’ of medical devices becomes much less relevant. For example, in the U.S. medical errors are the third-leading cause of death. In this country alone, more than 250,000 people die each year because of clinical errors, while some other sources claim this number to be no less than 440,000.

Of course, smart devices partly compensate for the human factor, and error-preventing algorithms coupled with artificial intelligence already participate in different medical procedures, including diagnostics, development and selection of treatment regimens, research of new medications, patient monitoring and care, and also are used in personalized medicine. Application of artificial intelligence has the potential to decrease the number of clinical errors and related incidents by 30-40%, while in some specific areas this rate potentially can be reduced by as much as 85%.

However, reaching these goals will not happen in the nearest future. A complete elimination of medical incidents also does not seem to be a realistic goal – especially in surgical procedures, where errors represent 40%-45% of all in-hospital adverse events. Some experts also note that there is a real risk that human may put too much trust in the smart systems that we are using in medical processes.

Cybersecurity is the new ‘Wild West’

A recent publication in the Financial Times highlighted a rapidly increasing cyber security threat faced by basically all medical device makers. The risk comes not just from stealing the patient data: hackers may target medical devices, or even attack individual people who use internet-enabled medical equipment. The risk for these types of incidents increases rapidly, as the Internet of Things (IoT) healthcare market keeps growing by about 43% each year.

It is clear that cybersecurity measures must be incorporated into medical device architecture. But even then it will be very difficult to ensure a completely fail-safe security environment in hospitals, let alone private care settings.

Conclusion

The fact is that the growth of the digital health market isn’t going to slow down over the next few years. Current innovations in medical error and medical incident reduction area will undoubtedly provide a certain increase over the current safety levels. However, future medical device developments will also introduce new threats, and from the incident management perspective we must be prepared to deal with them.

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