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and are subject to technical safety checks in accord-
ance with the Medical Device Directive and Medical
Device Operator Ordinance Section 6. These regular
safety checks must be carried out at least once a year.
This must involve carrying out a visual and opera-
tional inspection of functional and electrical safety in
accordance with VDE0751.
F
Furthermore, electrically operated care beds are
electrical appliances and their safety is the respon-
sibility of the employer. The supervisory function of
this obligation is the responsibility of the Berufsgenos-
senschaft für Gesundheitsdienst und Wohlfahrtsp-
flege (Employers’ Liability Insurance Association for
Health Service and Welfare Work – BGW) and the
Gewerbeaufsichtsamt (Trade Supervisory Board). The
regulations of the Employers’ Liability Insurance As-
sociation for Health Service and Welfare Work apply
in the place of work (abbreviated to BGV, formerly
VBG). In particular, BGV A2 (formerly VBG “Electri-
cal Units and Equipment”) applies, which requires
regular inspection of movable electrical equipment
with a guideline of six months, but at least once a
year. These inspections may only be carried out by
an electrical specialist or someone with electrical
training using a special measurement and inspec-
tion device. Inspections in accordance with BGV A2
can be carried out by specialist staff trained by the
manufacturer as part of the technical safety checks
for medical products, as these BGV inspections are
included in the technical safety checks.
Electrically operated care beds are active medical
products and must be listed in an inventory for each
site in accordance with the Medizinprodukte Betrei-
berverordnung (MedProd-BetrV), the Medical Prod-
ucts Operation Regulations. We recommend you
also document the proper implementation of the
required technical safety checks in this inventory and
note the date of the next inspection. The required
notes on technical safety checks already carried out
should be appended to the inventory.
Proper execution and traceable documentation of
the technical checks, maintenance and commission-
ing work prescribed by the manufacturer, as well as
the technical safety checks, are required in order to
preserve the warranty rights of the purchaser. If the
operator of a medical product does not meet their
obligations, this could lead to the risk of damage and
accidents for which the manufacturer is explicitly not
liable.
Any maintenance work is to be carried out in accord-
ance with VDE0751-1 and the subsequent technical
safety check is to be documented.
