Top 5 reasons medical device safety is a huge global problem

What are the top reasons why medical device safety is a huge global problem? Watch this short video or read my thoughts in more detail.

1.      Sheer numbers – Medical device volumes are exploding globally.  According to KPMG, the global medical device market will grow from $483 billion in 2020 to $795 billion in 2030, a 5.2% CAGR.  The major growth drivers are healthcare spending, ageing populations, chronic disease and technological development. More devices and more patients in developed and developing countries mean increased numbers of adverse events - more injuries, more complications and more deaths. 

For medical device manufacturers, the costs of quality events are sizeable. According to McKinsey, as much as 7% of revenues annually, or over $35 billion globally.

2.     Double-edged sword of innovation – Technology advances also introduce risks.

The pace of innovation in medical devices is breath-taking: novel in-vitro diagnostics, drug-device combinations, next generation materials such as graphene and bio-substrates, 3D and 4D printed instruments and implants, nano-scale robotics, IOT sensors and software as a medical device.  With such dramatic innovation in diagnostics and therapeutics comes uncertainty and risk.

Industry sources estimate 15% of devices are connected. These devices are also increasingly interoperable, software-enabled and algorithmically controlled. The result is a huge jump in cybersecurity risks.

Last year the chief information security officer of a leading US research hospital told regulators his organisation has 25,000 connected devices in its facilities.  These comprise 6,000 makes, models and versions with over 15 operating systems.  Many of these devices operate as families or clusters of inter-operable devices and equipment.  Every device is a snowflake. Keeping up with routine patches and upgrades is tough,not to mention urgent vulnerability mitigation.

Worryingly, some white hat hackers have observed that device-specific cyber-vulnerabilities could provide an entry point for lateral movement into a hospital’s IT systems, making real the possibility that a trauma centre could become a centre of trauma.

Regulators are keenly aware of the trade-off between these emerging technologies and the risks they present.  For its part, the FDA now insists that medical device manufacturers step up their games when it comes to post-market surveillance and adverse event management.  Under the EU MDR, heightened vigilance will be demanded from device manufacturers and distributors.

For more recent regulatory guidance, see US, UK and Canada.

3.     Overwhelmed and underfunded – Clinical engineers and medical technology specialists face huge challenges. They must track, monitor, and maintain growing volumes of increasingly complex medical devices and equipment across multiple delivery locations (e.g. acute care, community facilities and outpatient clinics, and home-based settings).

From beds, hoists and mattresses, infusion pumps, ventilators, flexible endoscopes, surgical instruments, radiation therapy and imaging equipment in an acute care setting to implants, closed-loop diabetes management systems and sensor-enabled asthma inhalers, the challenges in ensuring devices are safe and in good order at the point of care are huge.

4.     Standoff over servicing – OEMs, hospital systems and 3rd party service firms disagree about who’s accountable. On a day to day basis, this standoff about qualifications, competence and contractual obligations for medical device servicing further complicates an exceedingly difficult operating environment. 

(For more on this topic, including a recently issued FDA report on prospective regulation of ISOs, see my two blog posts).

5.     Data, system and organizational silos – Silos reduce transparency and delay action when it matters most. Without necessary visibility and traceability, it’s difficult for hospital staff to assure that medical devices and equipment are safe and in good order. 

Under-reporting of incidents and long supply chains delay action. It can take months or years for manufacturers to recognize and attribute adverse events to their devices.  Even then, root cause investigations (e.g. design, production, component failure, training protocols) crate further delays, leaving patients vulnerable to preventable injuries, complications and deaths.

At Spiritus, we keep a close eye on developments related to medical device safety, security and compliance.

Find out more and sign up to the Spiritus newsletter.