A shared "middle ground" for medical device management

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

One topic to which we have been paying close attention is medical device servicing. In the US, the FDA’s recent report on the subject has raised a host of questions - not only around the transparency, traceability, verifiability and auditability of serviced devices, but also around patient safety and outcomes.

In part one of this two-part series, ‘Stuck in the middle with you,’ I summarized the standoff between OEMs, independent service organizations (ISOs) and hospital systems about medical device servicing: 

  • Who should service devices and equipment?

  • By what standards should they abide?

  • How should regulatory guidance or oversight be designed and applied?

While they disagree on many points, both sides maintain that regulation would needlessly raise costs without improving patient safety.  

Notably, they also agree there’s a strong need for improved collaboration and data sharing among them.

Here in part two, I’ll look at how such data sharing might be enabled while still protecting the primary interests of the parties involved – OEMs, ISOs, hospital systems, clinicians, patients and regulators.  

Watch this short video to find out why medical device safety is a huge global problem.

Delivering the “middle ground” through selective data sharing

At a high-level, I propose an enterprise ecosystem of interested parties founded on a distributed ledger (DLT)/blockchain – a shared, permissioned registry on which relevant data would be recorded about the service history of specific assets.  

Importantly, a “rule of parsimony” would prevail about what data is recorded and shared.  This would mean that, by design, the choice of what’s recorded on the shared registry would protect proprietary interests yet also ensure that service actions taken by specific actors are performed timely and correctly.   

Only the information necessary to ensure a unique/discrete device or piece of equipment is safe and in good order at the point of care would be captured on the registry - cryptographically signed, traceable, verifiable and auditable by a defined set of ecosystem participants.

Over time, an asset’s service history would include artefacts and attestations of all service actions taken – from inspection, testing and certification activities during commissioning to routine maintenance and repair, reprocessing, and/or corrective and preventive actions during its operating life and, ultimately, through decommissioning, disposal and/or recycling for sale and re-use.

Other key design elements

Other key design elements of this ‘middle ground’ solution founded on DLT/blockchain include:   

  • Unique device identifiers (UDIs) in keeping with regulatory guidance

  • Product identifiers and product attributes such as parts, components, sub-assemblies and software ‘bill of materials’

  • RFID or other tags and scanner technologies paired with geo-location codes and services

  • Light-weight API integration to systems for asset management, field service, quality management, and governance, risk and compliance, as well as electronic patient records, incident management, infection control, and clinical workflow systems

  • Automated integration of recalls, field safety notices, safety alerts, and internal bulletins, cascaded downstream to equipment coordinators, engineers, clinicians, and/or social care staff

  • Robust analytics dashboards, including aging reports, availability status, and bench-marking among other metrics

It's worth noting that GS1's standards for unique identifiers, product identifiers and attributes, as well as location codes, provide a 'best in class' framework for OEMs and hospital systems and cornerstones of the proposed solution.

A solution that delivers for both sides of the debate

Establishing this shared registry that records each device's service history would bring benefits for both manufacturers and ISOs. 

OEMs will be better able to meet their post-market surveillance obligations in the case of adverse events. They will be able to see what repairs and corrective actions were performed by which third parties, and ensure that these activities are being carried out in ways that result in the safe and effective operation of devices. 

ISOs will benefit from improved access to the history of the specific device they are servicing. They will be able to see any failures that have occurred, parts that have been replaced, or upgrades that have been implemented. Information provided by the manufacturer, such as product specifications and training materials, can be appended to the record. All of this will help ISOs to reduce risk and determine the best course of action to take when servicing a device.

Evolving to include the Internet of Medical Things (IoMT) 

Once established in an acute care setting, the system could be extended to community facilities and home-based settings.  It could evolve to include the Internet of Medical Things (IoMT) - health and fitness wearables, sensor-enabled asthma inhalers, closed-loop glucometers and insulin pumps, frailty apps, and fall detectors.  In short, it could enable and support the future state of preventive care, self-management and ‘hospitals without walls’.  (For more on the IoMT market and connected medical devices, see Deloitte’s report).

Benefits of an enterprise-grade DLT/blockchain system

Whether in an acute care, community or home-based setting, software and systems must be enterprise-grade – scalability, performance and security go hand in hand with service delivery in a highly regulated operating environment where patient safety and privacy are on the line. (For more on enterprise-grade DLT/blockchain, see Hyperledger, EEA, R3 and Cambridge).

Enterprise-grade and secure by design, the  benefits to be derived from greater traceability, verifiability and auditability of an asset’s condition and conformity include:

  • Reduced patient safety risks

  • Improved clinical outcomes

  • Gains in operational efficiency and staff productivity

  • Greater insights for evidence-based care

  • Lower legal, audit and compliance costs

Raising the bar for medical device safety

At Spiritus, we believe there’s a promising ‘middle ground’ at hand for forward-thinking organizations when it comes to medical device servicing.  OEMs, ISOs and hospital systems open to joining an enterprise ecosystem and adopting new business and operating models enabled by enterprise-grade DLT/blockchain and analytics can raise the bar together.  Collectively, their collaboration could deliver meaningful returns measured in terms of improved quality, safety, security and clinical outcomes.

For more information about this “middle ground” and how we’re translating this vision into reality at Spiritus, send us a note at learnmore@spirituspartners.com.  

You can also sign up to the Spiritus newsletter to receive our latest updates.

Susan Ramonat