Artificial lenses that have not yet been approved by the Health Ministry were implanted into the eyes of five cataract patients this June.
The operations are at the center of a dispute between the management of Kibbutz Hanita, which makes the lenses, and senior workers at the factory. Management claims that the implanted lenses had been altered only very slightly from a previous, approved version, and therefore, according to American regulations that are also valid in Israel, a new permit was not required. The workers, however, say the altered lenses should not have been implanted without ministry approval, except as part of an experimental procedure.
For the time being, the ministry is siding with the workers: After a worker reported the five operations, the ministry forbade the factory to make any additional changes in the lenses without prior approval from the ministry, and also ruled that the current, slightly modified version of the lenses can be implanted only as part of a clinical trial.
So far, the ministry says, all the implants have been successful and no damage was done to the patients. However, by the operating doctors' own admission, patients were informed that the lenses were experimental only after the operation.
Some of the operations were performed by Prof. Ehud Asia of Meir Hospital in Kfar Sava, a paid consultant for the factory; the others were done by Dr. Yisrael Leshem of the Maccabi health maintenance organization's eye clinic in Ramat Aviv. Maccabi claims it used the lenses because it was misled by a factory representative; the factory denies this.
Ha'aretz has discovered that a similar incident occurred two years ago: A senior Hanita employee informed the ministry that lenses had been removed from the factory without his knowledge or consent and implanted in a patient at a local hospital. In this case, the lenses had already been approved in Europe, and a European license is valid in Israel, but the worker thought the ministry should have been consulted as well. A senior ministry official said the ministry did not handle the earlier case aggressively enough.
The official, who works in the ministry's department for supervising medical equipment, complained that the minister, the director-general and the ministry's legal department often fail to pursue investigations of complaints in this area. The supervision of medical equipment in Israel, he charged, is below even Third world standards.
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