Predictability in challenging times within the MedDev industry
The current global situation with the novel Coronavirus, COVID-19, is a fitting example of residual risk, also called unmitigated risk. This is the risk that remains after appropriate risk management measures have been put into place.
The world has suffered viruses before, the SARS pandemic in 2003 and the Ebola spread in 2015 being recent examples, and as such one would think that the medical industry in 2020 would be adequately prepared. However COVID-19 has still swept the world, despite the medical industry's prowess and attempted risk management, in an unpredictable way. We have witnessed the medical industry struggle to operate at maximum capacity as it attempts to tame the virus that has shown unpredictable levels of growth and infection.
The power of predictability
In challenging and unpredictable circumstances, the world relies on as much predictability as it can. Being able to rely on safe, standardised, and predictable devices that can be deployed quickly shortens reaction time and allows for swift solutions.
If a device, like disinfectant solution for example, has consistently met the regulations necessary, this could potentially reduce the time taken to address problems that arise in the testing phase.
The Standard ISO 13485 specifies requirements for a quality management system within the medical device industry. It supports manufacturers within the industry to design quality management systems to establish and then continue to maintain the effectiveness and safety of their processes and products. Using a Standard like ISO 13485 increases a device's predictability, making it a valuable and safe contribution to the public's health, especially in challenging times.
Medical Device production in challenging times
Due to strict Standards and regulations, medical devices are usually seen to be dependable and predictable. Devices are rarely released on the market without being proven as such. Keeping devices safe, reliable, and predictable when producing in a crisis is just as important. If a manufacturer has implemented a risk management strategy that is 'always-on', then staying compliant despite external pressures is more easily achieved.
Constant compliance leads to predictability
ISO 14971 is a Standard that helps manufacturers within the medical device industry execute a risk management system at every stage. From design to production, this Standard helps manufacturers manage and lower the residual risk in their products at every point. The measures put in place are flexible and are able to remain in place regardless of challenging and changing circumstances.
For example, with sky-rocketing demand for PPE (personal protective equipment) manufacturers are working to produce more devices than normal. This added pressure on the system could result in managers or manufacturers cutting corners and decreasing the quality of the product. The ISO 14971 Standard can help to ensure manufacturers remain compliant despite pressures and time restrictions.
Manufacturers in the medical device industry producing reliable and predictable devices in challenging times, such as the COVID-19 pandemic, means lowering the risk of the public's health.
Compliant now, compliant always
With urgent demands and a growing divide between the supply and the demand for safe and reliable medical devices, those in the medical devices industry are urged to refer to their Standards and meet their regulatory obligations to work towards keeping the public safe.
Understanding ISO 14971:2019
The medical device risk management Standard
The third edition of ISO 14971:2019 was published in December 2019 and provides a thorough process for manufacturers within the medical device industry to assess, monitor, and control risks in the creation and use of a medical device.
Medical Industry and Device Standards
Medical device quality management systems
Medical devices are created and used to provide care and services to those who require it. Their role is to assist with the health, wellbeing and safety of everyone involved. Standards are essential to ensure products and services meet benchmarks.
Quality Management Systems in Medical Devices
ISO 13485 specifies requirements for a comprehensive QMS
ISO 13485 is the internationally recognised Standard to assist those specifically in the Medical Devices industry to create a quality management system (QMS) that helps ensure safe and high-quality products are delivered.