Unapproved medical devices:Submission of written requests concerning the unapproved medical devices
2010-04-05
We submitted written requests concerning the unapproved medical devices to the Ministry of Health, Labor and Welfare dated April 5, 2010, and also mailed them to The Japanese Ophthalmological Society and to the Japanese Ophthalmologist Association.
In the wake of reported articles regarding LASIK eye surgeries, we conducted research on Google and Yahoo, and found that a lot of medical institutes are conducting LASIK eye surgeries by using unapproved medical devices.
Doctors are not prohibited to import unapproved medical devices for treatment for specific patient.
However, when doctors import the devices for the purpose of using them for unspecified and many patients, it is against the spirit of the Pharmaceutical Affairs Law that prohibits production and sales of unapproved medical devises on a regular basis.
In addition,if the devices have any problems,because of repeated use, a lot of patients will be exposed to risks, damages, and may spread widely.
Moreover, it is doubtful whether patients are informed that they are receiving treatments by unapproved devices, and the risks.
Therefore, we requested the following:
The MHLW should:
(1) Reform The Pharmaceutical Affairs Law in order to regulate importing unapproved devices for the purpose of repeated use for unspecified patients.
(2) Conduct surveys on the actual status of importing, and usage.
(3) Set up the new registration system for individual cases.
(4) Provide strict guidance for informed consent about the unapproved devices.
The Japanese Ophthalmological Society and the Japanese ophthalmologist association should:
(1) Conduct surveys on the actual status of importing and usage
(2) Provide strict guidance for informed consent about the unapproved devices.
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