Pharmaceutical & medical
A RELIABLE EYE ON HEALTH
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igid endoscopes are used in medical diagnostics and therapy to examine body cavities and hollow organs and to perform minimally invasive procedures. In order to avoid risks for patients and medical
staff, it is essential that the devices function perfectly. Reliable quality testing is intended above all to exclude risks from infections and injuries, but also misdiagnoses. In many countries, hospitals are required by law to regularly check and maintain their endoscopes to ensure that they function properly and do not contain any germs that are harmful to health. In addition, there are European guidelines and standards that regulate the quality assurance of rigid endoscopes. These checks are carried out by specially trained staff and include endoscopy tests and sterilisation tests as well as extensive visual inspections.
The Dutch company Dovideq Medical Systems specialises in measuring instruments for minimally invasive surgery. The current product range is aimed at central sterilisation departments in hospitals, endoscope manufacturers and endoscope repair companies. For the inspection of rigid endoscopes, Dovideq Medical Systems has developed various automated and networked systems. Particularly handy, small, light, cost effective and fast is the automatic endoscope tester LightControl. Using six test and measurement parameters, detailed data on the condition of the endoscope is recorded and evaluated. This ensures that only flawless endoscopes reach the operating theatre. The LightControl system ensures a high degree of efficiency and reliability with the help of IDS cameras from the LE camera family. For the safety of all, for the well-being of the patients and ultimately also for the benefit of the hospital balance sheet. The COVID-19 pandemic has brought the importance of hygiene and sterility of endoscopes and other medical devices even more to the fore,
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leading to a greater awareness of the need for automated inspection procedures. An endoscope that has not been properly cleaned and disinfected can cause the transmission of infection, and a defective endoscope can lead to injury during patient examination or treatment. No less serious are the consequences of a misdiagnosis or incorrect treatment if an endoscope does not function properly or is damaged, resulting in incorrect images.
Quality defects and the associated impaired functioning of an endoscope can have various origins. In addition to incorrect handling and lack of maintenance, these include factors such as material fatigue and contamination. Improper transport or unsuitable storage can also lead to damage, as can the simple ageing of the medical device. Lenses and other optical components can wear out over time, resulting in blurred or distorted images. To prevent bacteria or other pathogens from settling on the endoscope and thus not only impairing the quality of the images but, in the worst case, also harming the person being treated, they are regularly sterilised. However, the sterilisation process can also affect the quality and accuracy of medical devices, as the high temperatures and chemical substances used in the process can be potentially harmful to the sensitive components of the endoscope. In particular, heat and steam can trap moisture in the lenses and cause damage. In addition, some sterilising substances, such as formaldehyde, can have a corrosive effect on metal parts.
As complex as the possible causes are, as versatile are the possible damages of an endoscope. In order to efficiently deal with the complexity of the required inspection criteria, Dovideq Medical Systems has developed the patended LightControl visual inspection system. “With the help of the camera, it sees far more than the human eye of a surgeon, for example dirt particles, lens fractures, impurities or colour deviations,” explains Chielant de Wit, managing director of Dovideq Medical Systems.
LightControl runs the automated visual inspection with the aid of a uEye LE camera from IDS. Price, sensor and size were decisive factors in the choice of model. The built-in USB3 Vision industrial camera U3-3860LE Rev.1.2 is reduced to essential functions and has a light-sensitive Sony sensor. The integrated IMX290 with BSI technology (“back-side-illumination”) ensures excellent image quality with clean colour separation and enables true-to-life reproduction of the subject, which is so important here - even under poor or fluctuating lighting conditions. The camera is small and versatile; the lightweight, coated plastic housing is nevertheless robust. This makes it ideal for integration into small devices and embedded systems and predestines it for use in medical technology. For the automated quality inspection of endoscopes, Dovideq has identified six test and measurement parameters that the camera examines and about whose status the system provides detailed feedback in real time:
The “Lens Fracture” algorithm measures whether one or more internal lenses have a fracture. The “Particle Detection” algorithm finds out whether fine dirt particles, moist or other contaminations have entered the internal areas of the endoscope. For both measurements, the camera takes several pictures and makes a histogram from them. The system references the images in relation to previous images and feeds this data into a neural network.
“Light fibres” are measured in lux and are based on light emission. The light fibre measurement uses reference values to ensure that the fibres or fibre bundles of the endoscope allow enough light to pass through. This prevents the endoscope from providing unclear images.
June 2023 Instrumentation Monthly
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