eResearchTechnology GmbH AM3G01 User Manual
Page 35/42
Peak Flow Meter AM3 - Instructions for Use for Trial xxx
Version 00.03 • Date 04NOV2013
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, for repair, or for 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.
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, for repair, or for 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.
Due to infectious agents, pathogens or pharmaceuticals contaminated goods
pose a potential hygienic risk to all persons having contact with the returns.
pose a potential hygienic risk to all persons having contact with the returns.
This leaflet shall minimize 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 (info@bvmed.de).
In order to protect your and our employees who handle contaminated parts and to
optimally examine such parts, you should consider the following:
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 (info@bvmed.de).
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
Irrespectively of whether or not a contamination risk is known, products which had
direct or indirect contact with biological working substances (e.g. blood,
secretions or other body fluids) or with highly active pharmaceuticals (e.g. gloves
of the clinical or surgical staff) should be considered 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.
Irrespectively of whether or not a contamination risk is known, products which had
direct or indirect contact with biological working substances (e.g. blood,
secretions or other body fluids) or with highly active pharmaceuticals (e.g. gloves
of the clinical or surgical staff) should be considered 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.
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.
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.