Disposable baby delivery pack are mainly composed of surgical drapes, surgical gowns, surgical caps, gloves, umbilical clips, placenta, masks and other configurations for clinical use in obstetrics.
According to the adverse event report, the national adverse drug reaction monitoring center divides the adverse event performance into two categories: patient injury and device failure: ① patient injury is mainly manifested as: the user or the patient's contact with the product is swollen and painful, the baby's umbilical cord is infected, the baby's umbilical cord knot is bleeding, and the serious may cause shock; ② device failure is mainly manifested as: pad sheet, disposable surgical gown leakage, foreign matter or visible bacterial contamination in the maternity delivery pack, cord rubber band fracture.
The above analysis of adverse events leading to or possibly leading to serious injury shows that: the symptoms of redness, swelling and pain at the user's or patient's contact site are similar to the symptoms of skin damage caused by ethylene oxide (sterilization residue); the occurrence of infection is related to the degree of sterility of the delivery package or the operating environment; the hemorrhage at the infant's navel is related to the rupture of the cord rubber band of the component of cord ligation, which may be related to ligation operation. The quality problem of the product is not excluded; the leakage of pad and disposable surgical gown does not exclude the quality factor of the product, and may also be related to the improper operation of the user.
Based on the above product risks, Hefei C&P Nonwoven Products Co.,Ltd. adopted management and risk control measures such as strengthening product quality control, strict sterilization management, and strengthening user training. We strictly comply with ISO 13485 quality management system and EN 13795 standard. We have passed CE certification of TUV and obtained FDA registration.