Medical Device Material Compatibility – What is the impact of failure?

Why is infection prevention and control (IPC) important?

Even before Covid, the UK was seeing over 650,000 yearly cases of hospital-acquired infections, with around 5% of infected patients dying as a result. The survivors require extended hospital care, causing bottlenecks in hospital admissions and waiting lists, putting additional pressure on the healthcare system and reducing the success of patient outcomes. Recent data shows that a record of over 7 million people are currently waiting for treatment – It will take years to clear this NHS backlog. This adds pressure to the ongoing need for stringent infection prevention control measures.

Infection prevention practices are the strategies that a healthcare organisation uses to prevent and control the spread of hospital-acquired infections. These, among many other measures, include the regular, thorough sterilisation of reusable surgical instruments and cleaning & disinfection of medical devices.

What makes medical devices incompatible with IPC?

While healthcare organisations around the world are being advised to ‘do more cleaning’, there’s a case to be made to the manufacturers to say ‘do more research; listen to the problems’ and ensure that the products manufactured are truly fit for purpose in the healthcare environments for which they’re intended. There’s a worthwhile discussion to be had between the two parties to bring a better understanding of cleaning processes and compatibility to the table so that medical devices are designed to stand the test of time.

The range of metals and polymers used in medical devices includes many high-performance materials that contribute towards their durability and effectiveness. At the same time, not all of these materials are capable of withstanding repeated exposure to the chemicals, processes and technologies used in cleaning and disinfection.

Manual action, chemicals and disinfection technologies such as UV light sources can all cause deterioration of the surface and structure of many materials. As a result, medical devices are breaking, malfunctioning or failing prematurely when they are manufactured out of incompatible materials.

At the same time, the demands of complying with ISO 14001/13485 management systems are putting pressure on MedTech manufacturers towards greater sustainability through extended product life, so the choice of materials is becoming increasingly critical.

How can medical devices be made compatible with IPC?

The choice of cleaning and disinfection processes used for IPC strategies varies little between healthcare organisations, so if medical device design, manufacturing and instructions for use align with IPC strategies we can expect a higher degree of product performance and longevity.

However, as most materials offer a level of resistance to these processes rather than full proofness against them, it is important to establish whether the material complies with expected standards of resistance within an acceptable range.

While technical data sheets may give broad indications on the mechanical, chemical and UV resistance of materials in their raw state, the only definitive means of establishing real-world compatibility is to test the finished product under simulated conditions in a laboratory.

The increased use of disinfection and cleaning products on medical devices (especially the ones made from plastic) has already been linked with unexpected incidents where these devices failed or became damaged – making an existing problem even bigger and presenting a higher risk to the safety of patients and healthcare staff. These cleaning products are made to remove, kill or inactivate bacteria and viruses. However, they are not necessarily formulated to be compatible with plastics, and many medical devices are made of different types of plastics.

Where can medical devices be tested for IPC compatibility?

Rigorous, independent testing and validation of medical devices, carried out in controlled laboratory conditions, will ensure the results are consistent and reliable and streamline the certification process.

While there are many internationally recognised materials testing and certification organisations, Test Labs is a specialised medical device contract research organisation that, by listening to the experiences of infection prevention and control professionals, uniquely understands the challenges they face.

Through our Material Compatibility Testing and Assessment services, we provide expertise in simulated use studies and reprocessing validation to deliver tailored, highly customised solutions to clients in the MedTech sector. Our ISO 17025 accreditation gives our customers confidence in our ability to produce repeatable, accurate and reliable results.

What are the benefits of Test Labs TL Mark framework?

As a medical device manufacturer, you ‘own’ the surface area of your products that are deployed in hospitals and must ensure that all reasonable steps are taken to minimise the risk of those surfaces becoming a vector of transmission.

The TL Mark is a framework of IFU validation tests developed by and unique to Test Labs that enables products achieving TL Mark status to demonstrate compatibility with universally applied cleaning and disinfection processes.

The TL Mark framework will also demonstrate that you are committed to reducing the incidence of healthcare-acquired infection (HCAI) and can be relied on by healthcare organisations as a supplier of compliant, sustainable medical devices.