DECONTAMINATION
to 99.33 million units recalled per quarter, or 595.98 million in just 18 months. That represents a staggering 70.69% increase in the average number of units recalled per quarter. From 2005 through 2009, the FDA2
from 2006
received approximately 56,000 reports of adverse events associated with the use of infusion pumps, including numerous injuries and death. In the UK,3
to 2010, there was a significant increase in the number of device recalls and safety alerts – 2124 field safety notices were issued over the five-year period, showing a significant rise of 1220% (62 in 2006 to 757 in 2010).
In addition, 447 medical device issues
were reported in the same period, of which 44% of these devices were assessed and evaluated as having a potential probability of causing harm and adverse health consequences. More recent investigations in the UK are yet to be released. These were
the figures before the COVID-19 pandemic. We can assume that following advice to increase manual cleaning, in the last 18 months, there will have been an increased likelihood of medical device failures, with associated consequences. It is important to discuss the impact of environmental stress cracking in medical devices and how this ongoing issue can be tackled through collaborative measures.
What is Environmental Stress Cracking?
ESC is considered to be one of the biggest causes of plastics and polymers failure4
in
healthcare-related medical devices. It starts with the formation of crazes and brittles which can progress to aggressive cracking that eventually could break and damage the device integrity and function. This can arise as a result of repeated stress on the materials due to constant contact with secondary
chemical agents. A primary chemical agent is what the device is designed for and is rarely associated with causing failures – this is because the chemical compatibility is well understood during the design phase. A secondary chemical agent is often not expected to contact the plastic part during its lifecycle (e.g., chemicals in cleaning solutions). Cracks4
usually form at areas
where stress concentration is high, such as a notch, defect, surface scratch or a crack. This can be observed by noticing crazes or very fine voids which eventually start to form a crack. Cracks can grow and severely weaken the device or eventually create a full device failure.
Examples of ESC can be seen in components that are subjected to regular and constant exposure to cleaning agents that contain a variable profile of chemicals. Hospital medical and clinical equipment, which will often be exposed to alcohols, surfactants, and disinfectants during reprocessing, often experience ESC after multiple cleaning cycles. Issues rising as a result of ESC have always been reported, more specifically with electronic coatings and housings. For example, in 2013,5 a conference was held at the National Teaching Institute & Critical Care Exposition in Boston, US where twenty-seven medical equipment manufacturers were interviewed and reported experiencing cracking problems with polymer coatings – five of these reported the issue as “severe”. Such ESC issues could arise as a result of having chemical and mechanical stresses at the same time and could be as a result of material incompatibility. Device manufacturers and healthcare institutions need a very good awareness of exactly how the materials will be used and what type of chemical, thermal and mechanical stress that the device would encounter during its lifecycle. A device might function perfectly when exposed to one chemical, and easily crack in the presence of another. Given the nature for which medical devices are used, it is mind-boggling that other items contain more care and handling instructions – for example, laundry instructions on items of clothing. Therefore, there is an urgent need to call for better and clearer labelling either as a result of discussions and practical testing earlier in the product development stages or as part of ongoing development following field research and user feedback. Damages have been reported6
to tympanic
thermometers, patient monitors, infusion pumps and other devices, and it was stated that both detergent and disinfectant wipes can damage equipment if incompatible with the device components that are made of plastics. Damaged surfaces can harbour pathogenic microorganisms and impact adequate cleaning
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