In 2019, BeFitLab Testing Technology (Shanghai) Co., Ltd. collaborated with the local government to establish a medical device multi-testing centre. As a partner of BeFitLab, Auxergo also joined this collaboration to establish and operate the human factors and usability laboratory. The human factors laboratory includes a basic usability testing lab, surgery simulation lab, and ICU simulation lab.
The building work has progressed well, with the exterior completed at the end of November 2020. The internal construction phase is now underway, and is expected to be completed in March 2021.
The multi-testing centre basic information:
The centre is situated in Nantong (near Shanghai), China, is more than 8,000 square meters, and has had a total investment of 80 million RMB. It is equipped with a multi-axis fatigue testing machine, vascular stent fatigue machine, electromagnetic vibration table, scanning electron microscope, scratch tester, electrochemical workstation, chromatograph, nano pressure equipment, X-ray machine, and more than 500 other pieces of equipment. The centre implements energy saving, environmental protection, fire safety protection, occupational hazard prevention measures and complies fully with domestic and international standards.
The multi-testing centre includes:
Usability testing lab, surgery simulation lab, ICU simulation lab, static mechanics lab, fatigue mechanics lab, abrasion lab, chemical lab, optical lab, non-destructive testing lab, comprehensive lab, measurement lab, scanning electron microscope lab, cell lab, microbiology lab, electrical safety lab, transportation verification lab, environmental reliability lab, and vibration lab.
Human factors and usability lab:
The human factors laboratory includes basic usability testing lab, surgery simulation lab, and ICU simulation lab. The laboratory will carry out all the human factors work to help EU, American, Chinese or international companies to comply with FDA, IEC, MHRA, and NMPA human factors standards and enter their desired markets. The laboratory will be equipped with comprehensive human factors testing equipment such as an eye tracker, Vicon motion capture system, mechanical testing system, virtual simulation system, communication system, video monitoring system, surgical manikin, experimental bench, surgical equipment, and ICU equipment.
Medical equipment physical and chemical testing process:
The physical and chemical testing of medical devices mainly includes physical testing and chemical testing.
Among them, physical testing mainly involves physical testing of customer samples such as bending, stretching, torsion, impact, hardness, fatigue, abrasion, and aging; chemical testing mainly involves oil contamination testing, microbial residue testing, and testing of equipment samples provided by customers, chemical residue detection, chemical composition, etc.
Medical device biological testing process:
Biological testing of medical devices and drugs is mainly to implant medical devices or drug products sampled by customers into experimental animals (rats, rabbits, pigs, dogs, etc.) through surgery or intravenous injection to determine changes in related biochemical indicators, and observe the animal's adaptation and rejection of medical device product or drug, as well as monitoring histomorphological changes.
SPF animals are animals without specific pathogens and have special living environment requirements. The SPF animal room is a closed environment, and all objects and personnel must strictly follow the standard operating procedures for disinfection and sterilization. Food, rooms, and corridors are sterilized by ultraviolet irradiation; cages, drinking bottles, bedding, and staff clothing are sterilized by high-pressure steam sterilizers. The animal room uses a closed independent ventilation isolation cage (IVC) to house the animals.
The IVC consists of 4 parts: air supply system, exhaust system, frame, and cages. The air supply system is equipped with a purifying air conditioner, which can filter and remove bacteria in the air, and uses static pressure breeze technology to independently supply air to each cage. The bottom of the cage is covered with a material with good water absorption as bedding, which mainly absorbs animal faeces and urine, and is replaced twice a week, and the cage is washed twice a week with tap water.
Representative photo of the IVC:
Source and transportation of animals:
The animals come from qualified manufacturers with SPF laboratory animal production certificates. Each batch of animals has a quality certificate. The animals are transported in closed packaging cages, which are ventilated through high-efficiency filtration and breathable membranes. The manufacturers provide professional dedicated transportation vehicles for the animal transportation. Isolation and quarantine of purchased animals: an IVC is installed in the isolation room to isolate newly purchased animals. The newly purchased animals are kept in the IVC for 3 to 5 days to quarantine and undergo clinical observation. Animals that are in a poor condition are returned to the manufacturer and the manufacturer is responsible for transportation in accordance with the requirements of "Regulations on the Administration of Laboratory Animals" (revised in 2011).
Animal euthanasia is carried out with the carbon dioxide inhalation method to induce sleep and avoid unnecessary pain. This process does not produce waste that affects the environment. Finally, the carcass of the animal is place in a special plastic bag and temporarily store in a freezer at -20°C.
Some site construction photos: