20 percent of X-ray machines in human medicine have defects

June 2, 2023

Interference and artefacts on X-ray images can lead to misdiagnoses. Deficiencies in the protective equipment for patients are widespread. Most X-ray machines are found in dental practices. TÜV Association publishes “TÜV X-ray Report 2023”.

In many hospitals, medical practices and other facilities that work with X-ray equipment, there is a need for improvement in radiation protection. As part of the legally required safety inspections, TÜV experts found defects in 2,386 X-ray machines out of 16,027 inspected in 2022. This corresponds to a defect rate of 14.9 percent. This is the result of the “TÜV Röntgenreport 2023”, which was published today in Berlin. “The defect rates vary depending on the area of application. A good one in five X-ray machines used in human medicine has defects, while the figure for technical applications is only 5 percent,” says Dr. Alexander Schröer, radiation protection expert of the TÜV Association. Only in the rarest cases is there a danger to patients or staff. Schröer: “The technical safety of X-ray equipment in Germany is very high. No one has to worry about excessive radiation exposure during an examination.” According to the Radiation Protection Act, the safety of the equipment must be checked by independent experts before it is put into operation, in the case of major modifications and recurrently every five years. “Many deficiencies could be avoided if clinics and medical practices always conscientiously complied with the radiation protection specifications,” Schröer emphasises. Typical deficiencies in X-ray equipment are a lack of protective equipment and defective image receiver technology.

The devices depicted in the X-ray report cover the application areas of human medicine, dental medicine and veterinary medicine as well as technical uses. The defects are categorised as “serious”, “significant” and “simple/formal”. According to the X-ray report, in 2022 the experts found defects in 22 per cent of the 2,858 human medical X-ray devices inspected. The majority of the defects, 74 percent, were classified as “significant”. Significant defects must be eliminated and the elimination confirmed by the experts without a new on-site inspection. After all, 20 percent of the deficiencies were “serious”. As a rule, further operation is then not possible. Serious deficiencies have to be remedied immediately and the units have to be tested again. 5 percent of the deficiencies were considered “simple or formal”.

The most widespread in human medicine are so-called inpatient reception units, which are permanently installed in hospitals and at radiologists’, orthopaedists’ or lung specialists’ practices. The rate of deficiencies among the 1,008 audited inpatient reception units is 29 percent. With a share of 7.8 percent, the digital imaging plate and analogue film-foil systems were the most frequently found to be defective. With both systems, the films age and scratches, bends or dirt deposits can occur during long-term use. Interference spots or so-called artefacts can then be seen on the images, which in the worst case can lead to a misdiagnosis. In as many as 5 percent of the systems, missing or defective patient protection devices were the cause of a complaint.

Mobile C-arms, which can be used in operating theatres or other rooms, are in particular use in hospitals. In these devices, the X-ray source and image receiver are attached to a movable C-shaped arm. During examinations, operations and other procedures with X-ray support, almost any part of the patient’s body can be reached. Unlike other devices, the X-ray images are not stored digitally or in analogue form and only “diagnosed” after the examination, but are displayed live on a monitor. “Since all therapy-relevant decisions are made live on the screen with C-arms, the monitor must meet the necessary quality requirements and function absolutely flawlessly,” says Schröer. Among the 766 C-arms tested, the TÜV experts found defects in 24 per cent of the devices. The most frequent defects concerned image reproduction (11.3 per cent) and protective equipment (5.2 per cent).

The experts also inspected 259 computer tomographs (CT) in 2022, which are considered high-dose devices with high radiation intensity. The defect rate for CT devices is 5.8 per cent. Three devices had “serious” defects because the specifications for structural radiation protection had not been met. “In new buildings, it happens that the shielding of the radiation to the outside was not sufficiently dimensioned with the help of lead or by a wide masonry,” says Schröer. Such deficiencies could only be detected by the experts during an inspection before commissioning with the help of on-site measurements.

The majority of X-ray machines are in dental practices

The majority of X-ray machines are in use in dental practices and oral surgery. Of the 9,738 dental X-ray machines inspected in 2022, 16 per cent had one or more defects. Dental tube devices, which can be used to image individual teeth, are the most common. The devices are usually mounted on ceilings and walls or directly on the dental chair. The TÜV experts found defects in 15 percent of the 6,318 dental tube devices tested. Defects in the protective equipment are also a common problem at 6.3 percent. Since 2020, lead protection, for example in the form of a shield or apron, has been required for the radiation-sensitive thyroid gland. “This rule change has apparently not yet reached all dental practices, but can be quickly remedied with little effort,” says Schröer.

In addition, 2,996 panoramic imaging devices were tested, with which X-ray images of the entire dentition are possible. Defects were found in 17 per cent of all devices in this category in 2022. In 5.6 per cent of the devices, defects were found in the digital imaging plates or in the analogue film-foil systems, which, as in the human medical devices, can lead to interference or artefacts on the X-ray images.

X-ray machines are also used in veterinary medicine, for example to diagnose bone fractures in pets and farm animals. Of 826 X-ray machines tested, 15 per cent were found to have defects. In technical applications in industry or for luggage inspections, 2,605 devices were tested. The defect rate here is only 4.7 per cent. The two categories of equipment are not treated separately in the X-ray report, since the majority of the defects were of a formal nature and would not have led to an immediate danger to people. However, the requirements of occupational safety and radiation protection must be complied with here as well.

The complete “TÜV X-ray Report 2023” is available here. https://www.tuev-verband.de/presse/publikationen/reporte/roentgenreport

Methodology note: The basis of the “TÜV X-ray Report 2023” are the results of the inspections of X-ray facilities carried out by the TÜV organisations in 2022, which are required by the Radiation Protection Act.

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