This is an anonymous entry in our RBA document
Since this is for regulatory review, it's incumbent on you the manufacturer to convince the reviewer that the device is safe and effective. That the device is medically relevant to the current Standard of Care. Unless a new type of glove technology arrives that is MUCH SAFER AND EFFECTIVE I wouldn't worry. To do that lift you need to review and report on relevant literature
| HA NN.YY | Patient accidentally swallows device | Choking | Patient inserts device into mouth | The nature of the risk is choking. XXX has designed the XXX DEVICE to be larger than the dimensions of the Choke Test Cylinder used by the Consumer Product Safety Commission (CPSC)[1] which has a maximum diameter of 1.25 and depth of 2.25 inches. The XXX DEVICE is ZZZ long and OOO high and does not fit in the test cylinder. Based on the XXX DEVICE dimensions, it is highly unlikely that the device will create a choking hazard. In the event that the device is rolled into a smaller size and inserted into a child’s mouth, XXX has performed additional testing for small parts per 16 CFR part 1501 to confirm that the device does not create a risk of choking when rolled into a smaller size. Additionally, XXX has outsourced testing to an external lab per 16 CFR 1500.48 Sharp Point, 16 CFR 1500.49 Sharp Edges, 16 CFR 1501 Small Parts, 16 CFR 1500.51, 16 CFR 1500.52, 16 CFR 1500.53 and EN71-1:2014 Safety of Toys. XXX PRODUCT provides the user with the ability to (Insert what is the essential performance of the device) This benefit is greater than the residual risk remaining. No additional controls are considered necessary and this risk is considered Acceptable. |
