Bill seeks to limit faulty medical equipment

Legislation requiring Health Ministry to supervise medical equipment presented for the first time.

MK Arye Eldad 521 (photo credit: Marc Israel Sellem)
MK Arye Eldad 521
(photo credit: Marc Israel Sellem)
For the first time, legislation has been proposed to grant the Health Ministry responsibility for supervising the quality of medical equipment. A bill prepared by the Knesset Labor, Welfare and Health Committee, which will be read for the second and third time at a special session on Thursday, also sets a maximum NIS 3 million fine and three years imprisonment for manufacturers, importers and marketers who do not report problems with medical equipment.
The bill, which the committee revised many times, implements limitations and sanctions against those who did not report issues with the equipment, which ranges from small objects to MRI scanners.
Rules will be set down for registration and supervision of all medical equipment, and all equipment will have to be given special Health Ministry approval.
Only a few products – such as non-sterile bandages, dental floss, medical examination gloves, cotton wool and feminine hygiene products – will be exempt from registration.
According to the bill, the ministry director-general is entitled to provide exemptions from registration in cases that pose no risk to public health, such as equipment for research and export.
The ministry is also entitled to order restrictions on the use of certain medical equipment if it believes that its use may harm the public.
For the first time, there will be rules for reuse of equipment designated as disposable by manufacturers for profit purposes – such as catheters, which can be sterilized and reused rather than thrown away to save money.
Failure to register equipment as required may result in a fine of NIS 450,000 shekels. Anyone who makes use of medical equipment in contravention of limitations set by the ministry or fails to report product failures will face stiff fines and imprisonment, the bill says.
Hospital directors must ensure that employees use registered medical equipment and do so according to instructions.
Those who do not follow the rules will be liable for fines of NIS 226,000.
MK Arye Eldad (National Union), head of the subcommittee on medical equipment, welcomed the committee approval. “We succeeded in completing the preparation of the bill after years of work,” said Eldad, who is a trained physician specializing in maxillofacial and burns surgery. “Now, the Health Ministry will have to supervise and prevent dangerous equipment from being used. In addition, registration deadlines will be set down to prevent delays.”
MK Rachel Adatto (Kadima), a gynecologist by profession, congratulated the committee for finishing its preparations but added: “Even though it is a good bill, I am worried about the amount of work placed on the ministry’s shoulders.
There is a need for additional ministry manpower so the law does not fail.”
The Health Ministry commented that it was pleased by the legislation, which would position Israel “at the forefront of Western countries in the field and make it possible for Israeli medical industries to continue to flourish while protecting public health. The ministry intends to expand manpower in its units dealing with medical equipment as the law goes into effect so we can meet the law’s requirements.”