From: "Gibson, Malcolm" <[EMAIL PROTECTED]>
John,
Reading through the other documentation would indicate to me that the
responsibility for conformation with the Act lies with the manufacturer.
They should supply the customer with a Conformity Assessment Certificate
for all devices that are used for:
" * diagnosis, prevention, monitoring, treatment or
alleviation of disease
* diagnosis, monitoring, treatment, alleviation of or
compensation for an injury or handicap
* investigation, replacement or modification of the
anatomy or of a physiological process"
Any circumstances related to the failure of the device or recommended
use of the device that:
" led to the death of a patient or user of the medical
device or a serious deterioration in their state of health, or another
person, within 10 days after becoming aware of the event or
occurrence, or led to a serious threat to public health, within 48 hours
of becoming aware of the event, or that might lead to the death of a
patient or a user of the medical device or a serious deterioration in
their state of health, or another person, within 30 days of becoming
aware of the
event."
must be reported by the manufacturer. The user has an obligation to
report but it is voluntary and there is a form for doing this.
I would make sure any new devices and processes are certified before
using them and one could ask each supplier to provide Assessment
Certificates for devices in current use but they have until 4 October
2007 to complete transfer from the general listing in the Australian
Register of Therapeutic Goods to the medical devices listing. In
addition previously exempt goods must be listed with the ARTG by 4
October 2004.
I have no idea which goods currently used by diagnostic imaging
departments are listed on the ARTG - might have to get a list and have a
look!!
Kind Regards,
Malcolm Gibson
Area Manager - Northern Hospital & Regional Victoria
Mayne Health Diagnostic Imaging
The Northern Hospital
185 Cooper Street
EPPING VIC 3076
Ph: (03) 8405 9645
Fax: (03) 8405 9610
Mob: 0402 891 088
E-mail: [EMAIL PROTECTED]
-----Original Message-----
From: John Ryan [mailto:[EMAIL PROTECTED]
Sent: Monday, 1 September 2003 18:35
Subject: [AIRNEWS] TGA Approval
From: "John Ryan" <[EMAIL PROTECTED]>
Dear all,
I have recently been asked about the significance of the listing of a
variety of items relevant to radiography by the TGA. The items include
Software for Image Processing (Class 1), X-ray Films (Class 2a),
Diagnostic
X-ray Sources (Class 2b).
I have read the "Australian Medical Devices Guidelines, An Overview of
the
New Medical Devices Regulatory System, Guidance Document No.1", and am
not
much wiser.
It is available at http://www.tga.gov.au/devices/devices.htm
The possibilities seem too depressing to contemplate and I haven't
delved
further preferring the easy way out of learning from someone else's
experience.
Can anyone help?
John Ryan
_________________________________________________________________
Hot chart ringtones and polyphonics. Go to
http://ninemsn.com.au/mobilemania/default.asp
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