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.
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.
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
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
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
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
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.”