The use of medical devices in the province's medical equipment quality inspection news briefing stressed:
December 28th morning, the Guangdong provincial food and Drug Administration held in Guangzhou in 2016 the province's medical institutions medical equipment quality inspection briefing. Zhang Feng, director of the Guangdong provincial food and Drug Administration Safety Supervision Department of medical devices at the meeting informed the inspection of 100 hospitals, summed up the problems found in the examination. Provincial Food and Drug Administration spokesman Guo Yuhua presided over the meeting.
The meeting pointed out that in May this year, Guangdong province food and Drug Administration organized the province's "medical devices Quality Supervision and management measures" to evaluate the effect of the work, in accordance with the working mechanism of the Provincial Bureau of "double random open", were randomly selected from 100 hospitals (including three grade 30 hospitals, two hospitals were 30) the flight check". In order to ensure they will check full coverage, 183 experts in the expert database, expert medical equipment management organization of Zhongshan medical system, Nanfang Hospital, provincial people's Hospital, Guangzhou City People's Hospital and other 12 large general hospitals, discussion and research carried out from the aspects of medical examination content, examination method, examination standard, accident prone key management and use of risks in the process, from the three aspects of daily management, equipment management, material management, formulate scientific, professional and easy to operate, "Guangdong Province medical devices quality inspection plan". In order to improve the management level and quality of medical institutions in the province the use of medical devices, training them in check before the organization of the province's medical institutions engaged in medical equipment management personnel, teaching contents and methods of medical equipment management, and key requirements, carry out the management of the exchange of experience, discuss problems and solutions. On the day of the inspection group (for the first time in July 18th, second in October 19th), by the Guangdong provincial food and drug administration were randomly selected in 50 (two of 100) of medical institutions, were informed the 21 inspection team leader and local food and drug administration, inspection by experts and local food and drug administration staff together, "flight check on the selected hospital". Two after the completion of a comprehensive inspection, by the Guangdong Provincial Medical Consumables Management Institute to the Provincial Bureau of the province's medical institutions submitted to the use of medical devices quality management overall assessment report.
Inspection found that some units there is a temperature and humidity does not comply with the hygiene requirements, material storage for storing no logo or illegible, no warehouse area, cleaning status is not ideal; the two is the existence of the equipment maintenance personnel allocation, equipment operating personnel training for operation evaluation are not conventional and standardization, carry out the training records are missing or no documented phenomenon; the three is the information system of management is relatively backward, the information management of medical devices are mostly stuck in the financial management level, failed to achieve system certificate expires warning device management function, not even the way of information management; four is the number of grass-roots hospitals for medical use quality management is not enough attention, or because of the limited conditions, in the procurement, storage, use, maintenance and other aspects of management does not meet the Requirements and other phenomena.
The meeting stressed that the use of the quality of medical devices to ensure the safety and effectiveness of mechanical equipment is essential. In the past, the hospital procurement of medical equipment channels are not standardized, the cable card ticket work is not rigorous problems still exist; some hospitals, especially the grassroots hospitals ignore the maintenance of medical devices, the implementation of the security system is not in place.
In view of how to promote the implementation of the regulations on the supervision and management of medical devices, and improve the management ability and level of medical consumables, the Guangdong provincial food and drug administration requires the implementation of the "six strict". Is a strict management system, to further clarify, perfect, perfect the relevant management system, strictly grasp the implementation of the system, prevent the implementation of the system construction of light weight system; two is the strict approval management, to do a good job of purchase acceptance, the implementation of accountability, ensure the implementation of the system; three is the strict storage management, clear division of functional area, attention control temperature and humidity, prevent damage, and further improve the system, strengthen the implementation of strict management; four is used to regulate the orderly use, establish a feedback mechanism; five is the strict management of medical consumables management professional, to increase training, more learning, more improvement, enhancement of management responsibility; six is the strict information management and improve the management level and efficiency by informatization.
On this basis, the Guangdong provincial food and Drug Administration for the hospital how to regulate the management of large medical equipment, but also stressed the six strict requirements. One is the strict implementation of the system, particularly the strengthening of the new law and policy learning, constantly revised and improved hospital system, meet the requirements of the new policy, strengthen the implementation of the system; two is the strict inspection, in the equipment before entering the good relations, strengthen inspection and acceptance; three is the strict pre job training, through training to avoid problems in the use of the process, and constantly improve the training system, make training records, training and assessment, to ensure the standardized use of; four is to strictly regulate the use, avoid overload; five is the strict maintenance, to implement the usual small maintenance and regular maintenance of large, reaching certain service life to regular inspection, to strengthen the maintenance; six is the strict management of archives, to improve and perfect the archives management equipment, information management as a core, relying on information technology to improve management level.