A number of German TV stations and newspapers have recently revealed that accidents caused by implant surgery in Germany have occurred frequently. In 2017, there were 14034 cases of disability caused by implanted artificial medical materials and micro-instruments in the body, including implanted artificial hip joints, knee joints, breast fillings, insulin pumps, and pacemakers.
The Federal Ministry of Health has also confirmed the authenticity of this data, indicating that the number of related cases registered with the Federal Institute of Medicine and Medical Products is indeed increasing, but not all implants that cause disability and death are registered. For example, in 2017, as many as 3,170 cases had to be removed due to the failure of breast augmentation surgery, only 141 cases were actually registered in the relevant departments.
German media also revealed that almost all medical products implantable in Germany are not strictly tested, and only one in ten of high-risk implantable medical products have clinical data. Relevant German authorities generally require medical implant product manufacturers to recall defective products themselves or to provide safety warnings. From 2010 to now, manufacturers have issued thousands of recall statements or safety warnings every year, but the relevant departments have only disclosed six times at the same time, and patients and their families are basically unaware of them. Although the Federal Institute of Medicine and Medical Products has a lot of medical accident data in recent years, it is not disclosed to the outside world.
The International Journalism Survey Association’s survey shows that similar problems in other countries are also very serious. Defective medical devices in the United States in the past 10 years have caused 83,000 deaths and 1.7 million health injuries. According to the Federal Ministry of Health, the annual trade volume of artificial joints, pacemakers, hearing aids and other medical devices is as high as 282 billion euros per year, and Germany alone accounts for 30 billion euros. In vivo implant surgery has become a business opportunity. An industry that is risky for patients.
Urinalysis test strips refer to test strips that test for bilirubin, urobilinogen, ketone bodies, ascorbic acid, glucose, protein (albumin), blood cells, PH, etc. in urine.
Detection principle
1. pH: The pH value in the range of 5-9 is measured by the pH indicator, and the pH value of the fresh urine of a normal person is between 5-7.
2. Nitrite: The reaction is based on the reduction of nitrate to nitrite by Gram-positive bacteria in the urine. The nitrite reacts with p-aminobenzenesulfonic acid to form diazonium compounds, which are then combined with N-(1-naphthalene) )-3 aminopropanesulfonate combined with a pink color.
3. Glucose: According to the reaction principle of glucose oxidase, glucose oxidase specifically oxidizes glucose to generate glucuronic acid and hydrogen peroxide. Under the action of hydrogen peroxide, hydrogen peroxide oxidizes the indicator and turns color. .
Classification
Urinalysis test strips are divided into visual series and machine series. The visual inspection series is divided into several models according to different inspection items; the machine inspection series is divided into several models according to different applicable instruments.
1. Classification by measurement method
1) Visual inspection series
When observing the result, compare the color with the standard color code within the time specified on the color code, judge and read the result.
2) Machine test series.
For instrument operation, refer to the instruction manual of the Urine Analyzer used.
2. According to the number of measurement items
There are single-item, 2-item, 4-item and multiple test strips. Currently, 10-item or 11-item multiple test strips are most commonly used in hospitals.
3. Classification by structure
Urinalysis test strips with single-layer membrane structure and multi-layer membrane structure.
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