PRE-PURCHASE DECONTAMINATION QUESTIONNAIRE
Decontamination instruction review is required before the acquisition of all new or loan medical devices including
Reusable Invasive Medical Devices (RIMD) that may require some form of decontamination. No purchases or loans
should be accepted without the approval of the organizations nominated person for this purpose e.g. Sterile Services
Manager.
On rare occasions emergency procedures may require a swift decision relating to processing devices with no /
inadequate decontamination instructions. In these cases a procedure should be in place to quickly assess the risks
against clinical needs (e.g. infection, incompatibility, damage versus loss of limb/death), the decision should include
the clinician, DIPC, decontamination expert e.g. Sterile Services Manager and a member of senior management team
e.g. DIPC. A risk assessment should be completed and signed by those involved in making the decision. A local
procedure should be developed to reflect this process. See Annex A.
PART 1
This form is intended to supply our organization with information about your devices prior to purchase. It is to be used as a tool to determine whether our
organization can process your devices safely. Answer all sections, if a section is not appropriate indicate with “N/A”. Failure to do so may lead to your product
not being purchased.
A. Product Details
1
2
3
4
5
6
7
8
9
Supplier Name
Supplier reference No
Tel No
Fax No
E-mail
Generic Device Type
Device Model
Country of Origin
Manufacturer
B. CE Marking
(Tick or Circle as appropriate)
10
11
12
13
14
Does the product carry the CE mark?
Which Directive(s) does your device comply too?
Is the product a ‘custom-made device’ (93/42/EEC)?
Is the product intended for ‘clinical investigation’ (93/42/EEC) or ‘performance evaluation’
(98/79/EC)?
If intended for clinical investigation provide evidence of risk assessment eg ISO 14971.
Yes
No
Yes
Yes
No
No
Yes
No
Yes
No
C. Management System Standards
15
16
17
18
19
20
Is the manufacturer currently registered to any management system standards (eg ISO 9001, ISO
14001, ISO 13485)?
If YES, please state the standard(s) and certification body:
If NO, further investigation is required.
Is the supplier's “service / repair” organisation currently registered to any management system
standards?
If YES, please state the standard(s) and certification body:
If NO, further investigation is required.
D. Other Standards
21
Other than management system standards which standard(s) does the product comply?
If equivalency is claimed please supply appropriate evidence.
Standard
Test House
Certificate Number
Page 1 of 4
Date
E. Hazards
22
23
24
Does the product contain a source of ionising radiation or is it capable of emitting ionising
radiation?
Are there any specific hazards linked with the device?
If YES, describe:
Yes
No
Yes
No
Yes
Yes
No
Yes
No
No
Yes
Yes
Yes
Yes
Yes
Yes
Yes
No
No
No
No
No
No
No
F. Decontamination / Reprocessing
25
26
27
28
29
30
31
32
33
34
35
36
37
Is the item intended to be processed / reprocessed? If NO, do not reprocess.
What designation is the device Clean
Yes Disinfected
Yes Sterile
intended to be prior to use?
No
No
Is there a recommended maximum number of uses / reprocesses?
If YES, describe:
Are decontamination/reprocessing instructions supplied?
If YES, do manufacturer’s instructions meet ISO 17664?
Is the device uniquely marked to allow tracking?
Are there any contra indications when used with other materials?
Are instructions available for safe disposal?
Is manual cleaning the ONLY cleaning method specified before disinfection or sterilization?
If YES, has this validation been carried out in operational use? Evidence will be required
If YES, how is the device disinfected to allow safe handling prior to sterilization? Describe:
During the manual and /or automatic cleaning process what are the
minimum and maximum temperature and time that can be used for
washing/cleaning, thermal disinfection, rinsing and drying?
Minimum
Maximum
Time (Minutes)
Temp (0C)
38
39
40
41
42
43
44
45
46
Are there any restrictions on chemistries e.g. detergents, disinfectants and sterilants?
If YES, describe:
Yes
No
Temp (0C)
Where chemical disinfection is to be used Time (minutes)
Dosage (mls)
give the minimum/maximum time / temp / Min:
Min:
Min:
dosage parameters.
Max:
Max:
Max:
Can the device withstand autoclaving at 134 - 137 oC for 3 – 3.5 mins?
Yes
No
Has validation been carried out for UK routine steam under pressure sterilization parameters 134
Yes
No
- 137 oC for 3 – 3.5 mins?
Is the item compatible with other sterilization methods?
Yes
No
If YES, describe:
Yes
No
Does reprocessing require the use of specified equipment?
Yes
No
If YES, please state equipment type (e.g. containers, processors, etc) and, where appropriate, parameters of
operation (e.g. temp, pressure, etc):
47
48
49
50
Are tools required to aid dismantling/reassembly?
If YES, are they supplied with the device, describe :
Are lubricants required?
If Yes, describe:
Yes
No
Yes
No
51
52
53
Will lubricants affect the cleaning, disinfection or sterilization of the product
Yes
Yes
No
No
54
55
Are the trainers you provide appropriately qualified and hold evidence of this?
If YES, describe:
Yes
No
56
57
Are reprocessing instructions available on the Web?
If Yes, give web address:
Yes
No
Do you provide decontamination / reprocessing training for your device?
If YES, is this free of charge? Describe:
Page 2 of 4
58
59
Is the item single use but can be processed multiple times within a pack/tray until used? E.g
orthopaedic implants
If YES, how many times can it be reprocessed and how was this validated? Describe:
60
61
62
63
What is the total weight of the product including any containers that are supplied?
Are there any specific storage conditions before and after processing?
Has the device been involved in any “adverse incidents”?
If YES, describe:
Yes
No
Kg
Yes
Yes
No
No
G. Warranty
64
Please confirm that a copy of the warranty is provided on a separate sheet.
Yes
H. Declaration
When reference is made to this form and its attachments within the process of obtaining the item, we agree that the
purchaser will be entitled to rely upon the contents and subsequent non-compliance with the statements contained
herein will entitle the purchaser to seek redress.
Name:
Position:
Date:
Company / Address:
Decontamination instruction review is required for any new purchase or loan devices that require decontamination. No
purchases or loans should be accepted without the approval of the Trust nominated person for this purpose e.g.
Sterile Services Manager.
Page 3 of 4
PART 2
I. Other Information
SERVICE / SPARES / INSTALLATION
5.
Is service/repair information
available?
(Please state
YES, NO or N/A)
YES
Full circuit diagrams
Fault finding procedure
Repair information
Spare parts listing
If YES, please state whether also available
Disk
on:
6.
a)
If NOT f.o.c. please state current
price
NO
Indicate contents
below:
Preventative maintenance
Are special tools/test equipment/etc
required. If so supply separate list
If Web, please state
address
Website
In addition to the service/repair information/manual, will training be required before competent technical personnel can provide:
(Please state YES, NO or
N/A)
First-line maintenance
Calibration
Planned preventative
maintenance
Repair
Is the supplier able to provide this training for the purchaser’s or a third party’s technical personnel?
b)
If YES, will this be free of charge?
Or chargeable?
Indicate cost
If NO, please indicate if details of an organisation that is able to provide this training are available on
request?
YES
NO
YES
NO
Supplier's
Reference:
7.
c)
Is the provision of service/repair information conditional upon completion of training?
YES
NO
d)
In order to undertake maintenance/repair/calibration, is any special software/test equipment/tooling
required?
YES
NO
If YES, please indicate that details of special software/test equipment/tooling are provided on a separate
sheet:
YES
a)
Is the supplier able to provide an 'as required' repair/maintenance service in the UK?
YES
NO
b)
Is the supplier able to provide a contract repair/maintenance service?
YES
NO
If YES, please confirm that details of repair/maintenance contracts are provided on a separate sheet.
YES
c)
i)
If repairs are normally performed by the supplier on the purchaser's site, please state typical response
time:
ii)
If repairs are performed off-site, where will these be carried out?
Company:
iii)
8.
Typical turnaround
time:
YES
Location:
Is free of charge loan equipment normally available?
Please state if repair parts will be available to the purchaser’s or a third party’s suitably trained and equipped
YES
personnel:
If YES, is the supply of repair parts conditional upon acquisition of repair
YES
Or training? YES
information?
9.
Please indicate when this model was first placed on the market:
10.
a) For how many years from the date of last manufacture is the supply of spare parts guaranteed?
b)
11.
12.
Is the product still in current
production?
YES
NO
YES
If YES, please confirm that details of all services required are provided on a separate sheet:
YES
Page 4 of 4
NO
NO
If NO, indicate year of last manufacture:
Is installation necessary?
Will software upgrades be notified?
Will this be supplied FOC?
NO
N/A
YES
NO
NO