Medical devices are often at the pinnacle of cutting-edge technology and hence require a high level of inspection. This ensures that the equipment is performing like it should, sometimes in life threatening situations; and that there is a constant assurance of safety to both the user and patient. From the simple plaster to MRI machines, medical technologies are saving countless lives across the globe; estimates put the value of the medical device industry to be US$612bn by 2025.
The International Organization for Standards (ISO) has recently released a new standard its ISO 20417 – Medical Devices, in an aim to yet again improve the quality of inspections and keep the bar set high. For equipment and assets that quite literally save human lives, is there any debate as to whether there should be adequate inspections? Both ISO 20417 and its counterpart ISO 20416 version are aimed at “helping manufacturers meet regulations in the medical domain”, says Will Vargas, committee manager of the ISO technical committee. Luckily with the new standards and paperless inspections, medical device inspection within your organisation or business can be kept in top shape.
Medical device inspection is best conducted with paperless inspection solutions. Not only do these provide a quicker and more accurate inspection data, but they are more adaptable to new standards or regulations that may come out such as ISO 20417. By having all the checklists digital, small alterations to existing checklists to make them standard-compliant becomes an easy process. Equally as simple is adding an entirely new checklist to the daily reporting schedule. There are a host of other benefits for the user such as taking pictures with the device camera and annotating the picture to show compliance with a check. Scanning barcodes and using RFID is also possible, as is conducting any inspection using purely speech-to-text services. For inspection around sensitive medical devices that can otherwise be damaged or interfere with microwave signals, intrinsically safe mobile devices can be used to conduct inspections. Likewise for less hazardous environments, the regular smartphones and tablets can simply be used in offline mode to conduct an inspection. What is evident is that even in strict environments with delicate medical devices, paperless inspection solutions have a method to ensure a detailed and efficient inspection report is created.
