| Summary: | 碩士 === 國立陽明大學 === 醫務管理研究所 === 94 === Summary
In the medical treatment process, besides skillful treatment technique, comfortable environment, helpful psychological advices, well-informed patient communication, medical device quality is one of the important factors to directly influence medical treatments and obtain precise diagnoses. Meanwhile, it also indirectly affects the results of a patient from receiving treatments.
This research is based on medical device data from a medical center in Taiwan during five-year period (2001-2005 years).The data is to analyze the causes of faulty medical devices.
This database contains of medical devices (643 items) and its notification cases of faulty items are totally 1666 ones and exchange quantity is up to 379,099 pcs. This is equivalent to NT$5,180,337. The faulty items/events still occur even though there are twice-check procedures - quality inspection before reception and warehouse check afterwards. The faulty medical devices can be categorized into 16 types. Break, deformation, discoloration and leakage takes 34%. The second large type is tightness. Unacceptable cases take 12.73%. Transfusion difficulties and bad hydrophile cases are 8.34% and 8.22% respectively. From various data and purchase procedure, it can be learned that the medical center is low-price oriented. At the same time, this medical center also puts much effort on patient safety issues and actions.
Thus, to comply with medical device quality and lower its cost, TOC is applied. After this study, it is suggested the medical center can take the following plans:
1. Strengthen the standardization of trial system.
2. Rationalize purchase strategy
3. Administer discreet quality inspection
Concerning the Health authorities’work:
1. Implement the medical device inspection system
2. Reinforce the notification system of faulty medical devices In terms of suppliers:
1. Refer to the data with cause analysis which the medical center provides, then improve the faulty parts.
2. Strengthen the communication with management unit of medical devices and end-use unit respectively
3. Keep informed with latest information to further improve medical device quality.
The above actions must be repeatedly considered and eliminate obstacles and solve conflicts in order to find the best formula - medical procedure can work smoothly and further reduce the medical treatment disputes, enhance patient satisfaction and lower cost to obtain win-win results for everyone.
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