Monday, December 6, 2010

Medical devices should be tagged " undesirable incident "


Book list! (And medical school advice)

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What company of production of some medical devices produces is medical sticking plaster, complete 2009 province receives his inside limits undesirable incident reports 7, this year first half of the year 5. The report points out, the person that use appears after using this product the skin is red bilge, difficulties, bubbly wait for a symptom. For this, undertook investigating, undertook examining to the product, did not discover quality problem, dividing separate out to show the account of undesirable incident is this product form by the chemical product such as benzine, balata, colophony, zinc oxide, because of individual difference, after individual person is used, to the skin generation spurs action, the symptom such as occurrence rash. The operation instruction handbook that regretful is this product, undesirable incident that registers registration form to be caused to the likelihood the word was not carried, consumer not be in a position knows the use risk of the product.

Manual of product of medical devices does not indicate undesirable incident information is one is short of regret. Its reason is to concern code to be short of break, not mandatory requirement. " medical devices registers administrative measure " of the regulation " medical devices registers registration form " in expressing type, not " undesirable incident " column, " manual of medical devices, label and regulation of government of the label that pack " the manual points out generally " the content that ought to include no-no card, note and other need caution to perhaps hint commonly " , the information of undesirable without specific requirement designation incident.

Manual of product of medical devices tags undesirable incident information very be necessary, be helpful for be on guard the happening of undesirable incident. Wait for the one-time use infusion that form by PVC, plasticizer like what use extensively implement, because have adsorption or chemistry to some medicaments, together with infusion implement the aperture of medical fluid filter is controlled in 15 μ M commonly, the corporeal Yi Jin under 15 μ M enters human body blood-vessel, use the sensitivity crowd such as pair of infants for a long time to be able to produce undesirable event. If these are tagged on product manual, clinical and OK infusion of use blame PVC implement or the change gives medicine the way, can keep away from to atomic sensitivity crowd Chinese traditional medicine infusion or with accurate infusion implement, in order to ensure safe.

According to " consumer rights and interests protects a law " , consumer enjoys know its are bought, the right of the true condition of the service that use commodity perhaps accepts, safe to may endangering person, property commodity and service, ought to make true specification and clear caution to consumer, explain and indicate to use commodity correctly to perhaps accept the method of the service and the method that prevent harm happening. This shows, consumer has right of sufficient know the inside story to buying use medical devices, ought to obtain product of medical devices to may create the news of undesirable incident, this is a kind of protection to consumer, also be the legal obligation of generator. In the meantime, information of indicative and undesirable incident is helpful for protecting production to run a company, reduce legal risk.

The author thinks, it is mature with each passing day that requirement of undesirable incident information is tagged on manual of product of medical devices. In recent years, national bureau takes medical devices seriously very undesirable incident monitors the work, came on stage 2008 " undesirable incident monitors medical devices to run way with reappraisal (try out) " , each district built medical devices in succession undesirable incident monitors a network, increased medical devices the monitoring strength of undesirable incident, report quality had undesirable incident to rise apparently, the data of undesirable incident is progressively and perfect, accordingly, information of indicative on product manual undesirable incident can come true stage by stage.

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