Regulation update heralds wider spread of IoT in healthcare

While the EU’s updates to regulations around medical devices do not require providers to adopt any specific technological solution, healthcare teams should consider increasing their IoT adoption to make compliance easier.

The three year transition period of the former Medical Devices Directive (MDD) to the new European Medical Device Regulation (MDR) was expected to end in May 2020. However, postponed due to the coronavirus pandemic, it is now coming into full effect on 26th May 2021. On that date, the EU MDR’s implementation will require providers within the med-tech sector to ensure full compliance with each of its provisions, particularly the need to maintain an inventory of all medical devices. 

In light of the regulatory environment facing those who operate medical devices, now is a great time for wider adoption of IoT in healthcare. Integrating IoT not only provides the opportunity to streamline the collection of information, it also enables those in healthcare environments to better understand what is happening in their systems - which will yield even more benefits in time.

Moving from the EU MDD to MDR

The MDD, which was introduced in 1993, consists of three directives, which provide broad governance for medical devices in the EU plus Iceland, Liechtenstein, Norway, Switzerland, and Turkey. It has been the core regulatory framework governing medical devices; defining what constitutes a medical device, setting out standards relating to the conformity mark those devices had to bear, requiring medical devices are proven to be working and that the benefits of their operation outweighed any negatives they might also encompass.

The MDR is an expansion on that framework, imposing more demanding requirements on manufacturers to prove that their devices work as intended and that they have a system in place for surveillance to guarantee their product’s ongoing efficiency. The new framework imposes more onerous requirements on the 500,000 types of medical and in vitro diagnostic devices on the worldwide market too, including instituting heightened pre-market risk assessments and reinforcing a pan-European coordination mechanism for clinical investigation of high risk devices.

The updated MDR will also require that all medical devices have a unique device identification (UDI) code, which will be entered into the Eudamed database to ensure each is fully traceable, globally, back to their point of origin. This could, of course, prove to be very costly for those that need to implement the solutions.

Streamlining MDR required data collection

Achieving compliance with MDR dovetails perfectly with health system administrators’ current need to reduce contact between patients. IoT networks like Sigfox’s are the ideal technology solution here, as they help engineer this change in hospitals and other healthcare environments.

They can be easily integrated, and used in conjunction with local connectivity solutions such as WiFi or BLE to enable medical devices to achieve reliable network connectivity no matter where they are deployed in a healthcare setting and to connect multiple endpoints in a hospital network through one endpoint. IoT specific networks can also maintain contact with central inventory tracking systems irrespective of whether they are being used in patients’ homes, as telemedicine devices, or in hospitals.

For European healthcare systems, where there are a number of medical devices in active deployment, IoT can simplify inventory gathering and monitoring processes, and make it even easier to achieve MDR compliance requirements. By ensuring that each device is connected to a network, the process of keeping track of the devices in service can be carried out much more efficiently. Once the UDI code requirement is achieved in all medical devices, making an inventory of a healthcare system’s medical devices and uploading them to the central database can be carried out more efficiently in batches too.

Rather than viewing the updated MDR as yet another piece of regulation to deal with, administrators should consider its requirements as providing a perfect opportunity to implement better internal device tracking and data management systems. Given that the current pandemic itself has created a strong incentive for administrators to roll-out IoT use in their healthcare systems, MDR could be regarded as a positive catalyst for growth, encouraging those that have not yet considered or adopted IoT to do so.

Providing internal visibility and insights

In addition to assisting with compliance efforts, connecting medical devices to monitoring systems through IoT networks can help administrators gain great insights into device utilisation. One such example is the local authority Conseil Général du Loiret in France implementing a Sigfox-powered Lysbox system, which they used to track staff and contractors’ activity in a facility for the elderly.

After implementing the system, managers identified fraud, in the form of services billed by providers but not rendered, worth £3.14m. To avoid this happening again, those accessing the site are now required to carry a badge that is read by an IoT-connected sensor.

That same technology could be deployed in other healthcare settings to make sure that devices are not being stolen or misplaced, and a comprehensive cataloguing and inventorising process could easily yield similar cost savings while at the same time cutting down on fines for non-compliance with the incoming updated MDR.

Using IoT connected sensors to gather these sorts of insights could help healthcare workers to understand how and where tagged and connected devices were being used. They would also enable any inefficiencies to be easily detected so the overall efficiency of managing the facility itself could be improved.

The logistics sector is an industry outside the healthcare sector that has excelled in deploying IoT to both track resources in operation and pinpoint their whereabouts. Sigfox formed a partnership with Deutsche Post and ALPS Electric to heighten the freight companies’ ability to identify the location of rolling cages, with more than 250,000 cages to be tracked. This kind of implementation can also be used in healthcare systems to locate and keep an inventory of all medical devices currently being used - again to ease the process of achieving compliance with MDR.

Innovating for better healthcare

While the medical device industry may be used to dealing with regulations, the updated version of MDR calls for stronger controls over device surveillance. It places an increased burden on vendors and healthcare institutions to prove that the devices they utilise for patient care are safe and that each is logged in a centralised database.

An ongoing and robust data stream will assist with those goals being achieved much more effectively, and IoT is the perfect connectivity system to help the healthcare sector achieve them — and do a lot more. Beyond simply keeping an inventory of devices in use, healthcare operators can use IoT to achieve insights into how the devices are being utilized, so they can better manage these critical assets.