ARTD-002.731.

37E

SHS CS

Prophylactic measures against infectious

diseases in servicing and handling of
used equipment
Directive

Version 12

Hoxter, Philippe
SHS CS QT

Doc-Number Doc-Type Doc-Part Doc-Version

ARTD-002.731.37E AND 000 12

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 Prophylactic measures against infectious
diseases in servicing and handling of used ARTD-002.731.37E
equipment
Version 12 Directive

History
Document History

Version Date of Author Change Reason of Change /

Issue Change Request
12 2019-03-27 Hoxter, CHG00054111 Enhancement to integrate the handling of
Philippe used equipment
11 2018-05-25 Hoxter, CHG00042486 Enhancement of occupational safety handling
Philippe in Chapter 5.2
Note: due to new template format revision
history only contains information on current
version.
10 2016-02-29 Hoxter, Charm Chapter 4, Error! Reference source not
Philippe TD_00015955 [Link] 5.1 updated/enhanced to cover
the disinfection prior shipping in general
Attachment updated/enhanced

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 Prophylactic measures against infectious
diseases in servicing and handling of used ARTD-002.731.37E
equipment
Version 12 Directive

Table of Contents

1 Introduction............................................................................................................. 4

1.1 Purpose and Scope ....................................................................................................................4

1.1.1 In-vivo-business ....................................................................................................................4
1.1.2 In-vivo-business, used equipment.........................................................................................4
1.1.3 In-vitro-business ....................................................................................................................4
1.2 Transitional Arrangements .........................................................................................................4

1.3 Reference documents ................................................................................................................4

1.3.1 Process documents ...............................................................................................................4
1.3.2 Further informative references ..............................................................................................4
1.4 Definitions, Acronyms and Abbreviations ...................................................................................4
1.4.1 Acronyms and Abbreviations ................................................................................................4
1.4.2 Definitions ..............................................................................................................................5
2 General .................................................................................................................... 5

3 Important rules ....................................................................................................... 5

3.1 General .......................................................................................................................................5

4 Preventive measures .............................................................................................. 6

4.1 Specifics for used equipment .....................................................................................................6

5 Returned goods ...................................................................................................... 7

5.1 In vivo handling procedures .......................................................................................................7

5.2 In vitro handling procedures .......................................................................................................7

5.3 Used equipment or products processed in the countries ...........................................................7

6 Information on disinfectants ................................................................................. 8

6.1 In vivo information on disinfectants ............................................................................................8

6.1.1 Hand and skin disinfection ....................................................................................................8
6.1.2 Disinfection of equipment and instruments ...........................................................................8
6.1.3 Surface disinfection of equipment and instruments ..............................................................8
6.1.4 Surface disinfection of ultrasound heads and probes ...........................................................8
6.2 In vitro information on disinfectants ............................................................................................8

7 List of Attachments ................................................................................................ 9

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 Prophylactic measures against infectious
diseases in servicing and handling of used ARTD-002.731.37E
equipment
Version 12 Directive

1 Introduction

1.1 Purpose and Scope

1.1.1 In-vivo-business

Service activities may be necessary in rooms and on devices used to examine and treat patients with
infectious diseases. In isolated cases it may also be necessary to repair or service products
contaminated by residual blood or urine, etc., or to return these goods to CSML / the local depot after
disinfection.
Worldwide, infections possibly caused by such service calls have been very rare so far. In such cases
it has been impossible to prove their occupational nature with absolute certainty.
Nevertheless, strict adherence to the following safety guidelines and preventive measures are
required for all service activities involving possibly infected products, in order to minimize any possible
risks of infection.

1.1.2 In-vivo-business, used equipment

This directive applies to of Siemens Healthcare personnel and / or external business partner /
contracted service provider.

1.1.3 In-vitro-business

This procedure aims to define the process of decontamination of used analyzers and accessories
used by analytical laboratories or in a medical environment prior to dispatch or transportation to (from)
a client for the purposes of installation, storage, repair, verification, inspection or final utilisation.
The procedure covers all analyzers and accessories that can potentially be contaminated.

1.2 Transitional Arrangements

n.a.

1.3 Reference documents

1.3.1 Process documents

n.a.

1.3.2 Further informative references

[1] Decontamination procedures described in user manuals and service manuals of Siemens
Healthcare and as well analyzers

[2] Guidelines on biohazard and decontamination of devices or equivalent information obtained from
Siemens Healthcare

[3] Siemens Healthcare Guidelines on biohazard and decontamination concerning OEM products

1.4 Definitions, Acronyms and Abbreviations

1.4.1 Acronyms and Abbreviations

n.a.

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diseases in servicing and handling of used ARTD-002.731.37E
equipment
Version 12 Directive

1.4.2 Definitions
Term Definition
Analyzer The main device that performs analytical tests or prepares, transports and
sorts patient samples with all equipment.
Accessories Any peripheral element that is necessary for the analyzer to fulfill its function,
e.g.: external printers, computers, monitors, keyboards, indication devices
including computer mice, power adapters, air compressors, water
conditioning stations, electrical wiring, etc.
CSE Customer Service Engineer
IVK Installed Volume Component
Medical Dedicated personnel responsible for decontamination of medical equipment
Staff/customer/custo
mer
PM Project Manager
SP Service Provider, in this context a person or team trained to perform the
required tasks related to this document
used products Marketing and offering of used products that are returned back to the field
shall be strictly limited to products that have undergone processes to ensure
safety and effectiveness of the systems

2 General
This document applies to all service parts, components or complete equipment, in the countries.

3 Important rules

3.1 General

 Avoid all skin contact with potentially infectious material such as blood, body fluids or other
excreta.
 Prevent injuries – do not work with unprotected wounds in areas where there is danger of
infection.
 Protect all wounds, even the smallest, including scrapes, cuts and eczema, from contact with
potentially infectious material.
 Strictly observe the requirements of hygiene and body protection, e.g., protective clothing,
disinfection, proper hand disinfection, gloves etc.
 Eating, drinking and smoking at the workplace (located at customer sites) are prohibited.
 To minimize the risk of spreading possibly infectious, contaminated material within clinical
areas, only use an antistatic vacuum cleaner with plastic sealed cartridge HEPA filter (0.3
micron or better) e.g. Convac - 3000C or 3000CQ, Atrix International - Omega Supreme Plus
HEPA or 3M/SCS - 497ABF with SV-SPF1 filter. Also observe any country specific
regulations. For diagnostic systems in large laboratories or where track based systems are in
use it is recommended to leave a vacuum cleaner on each site to minimize the risks from
transporting possible infectious hazardous material between sites. Some laboratory sites
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 Prophylactic measures against infectious
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equipment
Version 12 Directive

already have a vacuum cleaner available for this purpose but please confirm it is anti-static
and has HEPA filtration. Ensure the filter cartridges are disposed of safely in line with local
regulations for bio-hazardous material
 Customer Service Engineer (CSE), Application Specialist (Apps/CES) or a designated person
are responsible for disinfection of devices prior to servicing and dispatch.

4 Preventive measures

 In the case of contaminated and/or possibly infectious products, the following principle applies:
"Clean first then disinfect; then perform service activities.”
 Before performing service or maintenance activities, please contact the responsible Medical
Staff/customer whether these activities have been performed. The Medical Staff/customer is
responsible for disinfecting and cleaning procedures.
 Disposable protection gloves (e.g. unpowdered Latex, Vinyl or Nitril) shall be worn during all
service and maintenance operations to prevent contact with blood, excretions, pus, infectious
materials etc. Apart from this regulation, however, we generally recommend that disposable
gloves be worn also during all other service work.
 After performing any service or maintenance operations, disinfect all potentially infected tools
as well as any service parts intended for return.
 Disinfectants must be effective against HIV and hepatitis B viruses. Usually, they are available
with the customer during disinfection and cleaning, the disposable protection gloves
mentioned should also be worn.
 After completion of service work, the worn gloves should be properly disposed or put into the
container labelled Biohazardous Waste provided for this purpose.
 Even if gloves have been worn, hand disinfection is required after service activities. Proper
hand washing should be completed, hand disinfectants shall be applied.
 Operations in areas where there is danger of infection or activities on potentially contaminated
products shall always be noted in the travel report or in an action report.
 When experiencing any inexplicable feelings of illness or any other impairment of health, or
suspecting a potential infectious disease, please contact your EHS department as soon as
possible.
If it is suspected that an illness can be traced back to service operations or to working with
possibly infectious products, superiors have to be informed immediately.
If an occupational injury or illness may be involved, the incident must be carefully
documented.

4.1 Specifics for used equipment

 The Medical Staff/customer is responsible for disinfecting and cleaning procedures of the
entire medical system. Before performing any activities, please contact the responsible
Medical Staff/customer whether these activities have been performed and documented. A
copy of this confirming document shall be accompanying the medical system as part of the
attached documentation.
 After performing any task, disinfect all potentially infected tools as well as any service tools
intended for return.
 Disinfectants must be effective against HIV and hepatitis B viruses. Usually, they are available
in the clinical environment, the disposable protection gloves mentioned should also be worn.
 After completion of all activities, the worn gloves should be properly disposed or put into the
container labelled Biohazardous Waste provided for this purpose.
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diseases in servicing and handling of used ARTD-002.731.37E
equipment
Version 12 Directive

5 Returned goods

5.1 In vivo handling procedures

The CSE is required to disinfect on-site any potentially infected service parts that are brought into the
returned parts cycle (CSML or local depot). Disinfection of the surface with an appropriate spray is
required before returning goods.
Disinfection of ultrasound heads or probes must be carried out by clinical staff, since only specific
disinfectants may be used with them (see paragraph 6.1.4 ).
After disinfection is complete, a certificate of decontamination containing date, name and signature,
shall be placed on the packaging of the service part in a noticeable place.

5.2 In vitro handling procedures

Parts for disinfection and dispatch should be stored in a defined place in a warehouse or workshop. If
local processes require specific documentation, it should be prepared.
Administration or Regional Service Manager designates an employee who prepares the device for
transportation and performs disinfection at the same time.
During disinfection, protective gloves shall be worn with the following labels:
standard protection against mechanical risks
standard BIOHAZARD sign, protection against biological factors/microorganisms
standard protection against chemical factors
Sample tubes, cuvettes, used reagents should be disposed of, other fluids should be pumped out of
the device, and all single-use elements (e.g. syringes, pipettes, needles, waste containers, etc.)
remaining in the device should be disposed of to labelled containers for infectious waste.
If the Hospital or Laboratory refuses to take care of/utilize waste, it shall be packed and secured, and
the Service Administrations should be contacted, as they will call a company specialized in infectious
waste management.
The analyzer/accessories, including multiple-use elements (e.g. tubes, needles, probes, wash
stations, etc.) shall be decontaminated (disinfected and cleaned) and secured against a potential
injury (for example by fixing a probe in the parking position or by applying a tubing on a needle) to
avoid hazards, while surfaces which may have had contact with infectious material must be disinfected
using disinfection agents as required by local law and/or local procedures.
After disinfection is complete, a certificate of disinfection containing company name, ID for
analyzer's/accessories' country of origin, date, name and signature, shall be placed on the packaging
of the analyzer and accessories in a noticeable place.
Analyzer/accessories prepared for dispatch, secured and appropriately labelled are transported by a
specialist shipping/courier company according to local working instructions or processes.

5.3 Used equipment or products processed in the countries

In close cooperation with the Medical Staff/customer the CSE or the SP shall make sure that any
surface that is accessible i.e. all covers or accessories are disinfected.
For removal of a complete system it may be necessary to disassemble the system to a certain extend
Example 1) A patient table separated from the Magnet of an MR system.
Example 2) Removal of covers to access connected cables, fixation screws etc.
Consequently the now accessible surfaces have to be cleaned and disinfected.
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 Prophylactic measures against infectious
diseases in servicing and handling of used ARTD-002.731.37E
equipment
Version 12 Directive

Disinfection of the surface with an appropriate agent is required before packing goods.
After Disinfection is complete, a certificate of disinfection containing date, name and signature, shall
be placed on the packaging of every Item in a noticeable place.

6 Information on disinfectants

6.1 In vivo information on disinfectants

The following section lists some disinfectants as well as their sources of supply if they are needed.
The materials listed are distributed in the Federal Republic of Germany. In regional subsidiaries,
disinfectants of equivalent effect should be used if they are needed.
The disinfectants are effective against hepatitis B and HIV and against different viruses and bacteria
listed in the disinfectant product description.
When using them, please note the time they require to take effect. (see product description)
All of the following products can be obtained from the listed distributor and manufacturer:
Pursept A EXPRESS: Microzit sensitive liquid/Gigasept:
Merz & Co KGaA. Schülke & Mayr GmbH
Eckenheimer Landstraße 100 Robert-Koch Str. 2,
D-60318 Frankfurt am Main D-22851 Norderstedt
It is important to note that customers typically have an approved disinfection product on site that may
be used.

6.1.1 Hand and skin disinfection

Recommendation: „Primasept M“- preparation for hand disinfection or adequate disinfectant.

However, good, proper hand washing shall not be disregarded for use of any skin disinfection.

6.1.2 Disinfection of equipment and instruments

(i.e., disinfection bath for instruments and small devices)

Recommendation: “Gigasept“ or adequate disinfectant.

6.1.3 Surface disinfection of equipment and instruments

Recommendation:
“Pursept A EXPRESS “ – disinfection towels & “Pursept A EXPRESS“ – pump spray or adequate
disinfectant.

6.1.4 Surface disinfection of ultrasound heads and probes

Recommendation: “Microzit-sensitive liquid” or adequate disinfectant.

6.2 In vitro information on disinfectants

Substances and fluids suggested for disinfection of external surfaces of analyzers/accessories that
may have had contact with infectious material are:
TERRALIN®protect or Incidur Spray

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 Prophylactic measures against infectious
diseases in servicing and handling of used ARTD-002.731.37E
equipment
Version 12 Directive

Substances and fluids suggested for disinfection of analyzers (you should study analyzer’s
documentation and use an appropriate product):
2-Propanol (Isopropanol) p.a. purity, FP reagent
Sodium hydroxide 0.1 mol/L (0.1 N) standard solution
Ethyl alcohol anhydrous, 99.8% p.a. purity, FP reagent
Selective MicroClean 2L50A
Prebe wash or other fluids listed in the manual
Product suggested for skin disinfection:
Skinsept Pur
Hydrogen peroxide
Other disinfection agents available in the laboratory
Please follow the safety instructions of the manufacturer of the disinfectants for application!

7 List of Attachments
ARTD-002.731.37E AND 001: “International certificate of disinfection/transportation/for utilization”

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diseases in servicing and handling of used ARTD-002.731.37E
equipment
Version 12 Directive

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SAP-EDM Signature Information Page 1 of 1
- generated automatically by SAP system P41 -

Appendix to Document: ARTD-002.731.37E AND 000 12

Sheet generated at : 2019-04-09T12:08:27 UTC
Originator : SIEMENS Healthcare, P41
Signatures related to this document and performed in SAP:

Meaning UTC date and time surname, given name of signee

AUTHOR 2019-04-01T11:27:43 Hoxter, Philippe

APPROVAL 2019-04-09T12:07:56 Debus, Frank

CHECKED 2019-04-01T11:51:53 Vedder, Meike
CHECKED 2019-04-01T15:04:49 Schmelzer, Alexander
CHECKED 2019-04-08T11:55:51 Schweigert, Michael