Use Instructions

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MasterScope - Instructions for Use
Version 03.00 • Date 19FEB2020
Products which are potentially contaminated by biological working substances
of risk group 4 according to the regulation on biological substances as well
as products which are potentially contaminated by pharmaceuticals posing a
serious risk to health (e.g. X-ray contrast agents and cytostatics) must not be
returned to the producer.
Due to infectious agents, pathogens or pharmaceuticals, contaminated goods
pose a potential hygienic risk for all persons having contact with the returns.
Return of Goods in Medical Institutions
Recommendations for action -
for all staff members having contact with potentially contaminated returns.
Returns or returned goods are all products returned to the producer or the
supplier, irrespective of whether or not they have been used, e.g. due to
complaints, repair or maintenance. Those products might have had contact with
biological substances or highly active pharmaceuticals (e.g. cytostatics, radioactive
medicines) and could be contaminated by them. If in doubt, the goods to be
returned should be treated as contaminated products.
This leaflet provides guidance on minimizing the potential hygienic risk when
handling returned goods. Among other things, this information is based on the
legal standards of the Biostoff-Verordnung (= Biological Substances Regulation)
and the Employment Protection Act (both valid in Germany). A more detailed
reference list of applicable rules and regulations can be obtained from the BVMed
([e-mail]).
In order to protect your and our employees who handle contaminated parts and to
optimally examine such parts, you should consider the following:
1. Assessment of returns before reshipment
Irrespective of whether or not a contamination risk is known, products which had
direct or indirect contact with biological working substances (e.g. blood, secre-
tions or other body fluids) or with highly active pharmaceuticals (e.g. gloves of the
clinical or surgical staff) should be regarded as potentially dangerous to health.
According to the regulation on biological substances, substances of risk group 3
can cause severe illness in humans and pose a serious risk to staff members (e.g.
tuberculosis or hepatitis). Substances of risk group 4 cause severe illness in
humans and pose a serious risk to staff members (e.g. Ebola or smallpox).
Regarding national and international regulations for the transport of potentially
infectious substances (ADR, IATA-DGR), the risk groups 2 (e.g. staphylococcus
aureus) and 3 defined by the Biological Substances Regulation are classified as
Transport Category B.