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? Here are my Top 5.

1.      Sheer numbers – Whether measured by revenues or volume, the numbers are staggering.  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 – The handmaiden of innovation is risk.  Notwithstanding rigorous clinical trials and pre-market regulatory requirements, unexpected problems arise when new technologies are introduced.

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 - both known unknowns and unknown unknowns.

On the information technology side, for instance, connectivity, interoperability, software and algorithms could introduce unrecognized and/or unfixable bugs and faults.  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.

3.     Volume and complexity – Overwhelmed and underfunded, clinical engineers, medical technology technicians, sterile services professionals, and home care specialists 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.

Turning back to software and connectivity as sources of risk, 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.  To his lament, each device is a ‘snowflake’, greatly complicating routine patches and upgrades, not to mention urgent vulnerability mitigation.

He’s not alone in facing this challenge.  According to industry reports, roughly 15% of medical devices and equipment in hospitals are connected, and the numbers are growing sharply. (For recent regulatory guidance, see US, UK and Canada).

4.     Standoff over medical device servicing – An old adage says, ‘Too many cooks in the kitchen spoil the broth’.  When it comes to medical device servicing, there’s a hot-blooded standoff between manufacturers/OEMs, hospital systems and independent service organisations (ISOs). 

Sharp disagreements exist about who’s qualified, competent, accountable and liable for maintenance and repair (M&R) and corrective and preventive actions (CAPA).  On a day to day basis, this standoff complicates an exceedingly complex operating environment. 

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

5.     Lack of transparency and siloed information – Fragmentation of servicing across many parties also contributes to data and information siloes. These siloes make it difficult for hospital staff to assure that medical devices and equipment are safe and in good order. 

Making things worse, extended supply chains and under reporting of incidents contribute to long cycle times before manufacturers recognise and are able to attribute adverse events to their devices.  Even then, root cause investigations (e.g. design, production, component failure, training protocols) may take months.  As a result, recalls, field notices and safety alerts are delayed, 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.

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Susan Ramonat