Medical network - February 7, recently, the provincial food drug administration issued by the "hebei province drugs and medical devices safety emergency plan (try out)". The emergency plan, will guide and standardize the drugs and medical devices in our province safety incident emergency disposal work, effective prevention and control in a timely manner all kinds of drugs and medical devices safety incidents, minimize incidents of damage to public health and life safety.
Based on the endangering degree from the event and the influence factors such as the scope, drugs and medical devices in our province safety incidents from high to low is divided into levels Ⅰ (especially serious), Ⅱ (major), Ⅲ (larger) and Ⅳ (in general).
Emergency plan request, the food and drug supervision and administration departments at various levels shall set up a monitoring system for drugs and medical devices safety incidents, strengthen the key varieties, key link, especially in high-risk varieties of quality and safety of the daily regulation. By adverse drug reactions or medical device adverse event monitoring system, drug abuse monitoring system, the complaint reporting system and the examination mechanism to collect summary of drugs and medical equipment safety and emergency information, monitoring of potential drugs and medical devices safety event information.
Pharmaceutical production and management enterprises find or learn drug safety emergency happens, shall be immediately to the local food and drug administration, adverse drug reactions or medical device adverse event monitoring agency's report, the medical institutions in discovery or learn drugs and medical devices safety incident happens, it shall immediately report to the local health administrative departments of family planning, report to the local food and drug supervision and administration department at the same time. The latest time report shall not be more than 2 hours.
In the food and drug supervision and administration department after receiving reports, the local government should be in 2 hours and the food and drug supervision and administration department report, and immediately went to the scene of incident investigation to verify.
The food and drug supervision and administration departments at all levels according to the monitoring information, drugs and medical devices within the administrative area safety emergencies related risk factors were analyzed, and the possible risk factors for a public health hazard, risk level, influence range and degree of emergency and possible hazards evaluation opinions, report to the level of the food and drug supervision and administration department in a timely manner.
Corresponding emergency medicine and medical instrument classification, medicines and medical apparatus and instruments of emergency response from low to high levels in turn divided into Ⅳ, Ⅲ, Ⅱ, Ⅰ four level of response.
Verification for generic drugs and medical devices sudden emergencies, the accident occurred in the county (city) the food and drug supervision and administration department to start the Ⅳ magnitude response, and to the districts municipal food and drug supervision and administration department and county (city) government reports, notices health associated with events such as family planning administration.
Approved for emergency medicine and medical instrument, the larger by accident districts and municipal food and drug administration started Ⅲ magnitude response, to the provincial food and drug administration, divided into districts and municipal government, notice health associated with events such as family planning administration.
For approval to a major sudden emergencies, medicine and medical instrument by the provincial food and drug administration started Ⅱ magnitude response, and to the provincial government, the administration of state food and drug supervision and administration, notice health administrative related to events such as family planning department.
Approval as special major sudden emergencies, medicine and medical instrument by the provincial emergency headquarters suggest start Ⅰ magnitude response, with the approval of the state food and drug supervision and management of administration after startup.
After the occurrence of emergency medicine and medical instrument, county (city) the food and drug supervision and administration department should immediately together with the relevant departments, in a timely manner to carry out early treatment work of the crash. Through the analysis of the accident assessment, check and ratify special major drugs and medical devices for emergency, by the state food and drug administration bureau unified leadership and command accident emergency disposal work; At the beginning of the sentence to major emergency medicine and medical instrument, by the provincial food and drug supervision and administration department of emergency work leading group is responsible for organizing the command event emergency management work; At the beginning of the sentence to larger emergency medicine and medical instrument, the districts and municipal food and drug supervision and administration department is responsible for the organization command accident emergency disposal work; At the beginning of the sentence to general emergency medicine and medical instrument, the county (city) the food and drug supervision and administration department shall be responsible for the organization of the command of the accident emergency work. Food and drug supervision and administration departments at all levels should be taken to start the response, hazard control, medical treatment, inspection, expert analysis, information summary some emergency measures, such as maximum limit to reduce accident harm. |
