Medical Devices Safety Update
Volume 4, Number 5, September 2016
In this issue
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Industry Code aims to minimise button battery dangers for children
Practice Points: Medical device Instructions for Use documents can aid clinicians
Software as a medical device: a summary
Recent safety alerts
Industry Code aims to minimise button
battery dangers for children
An Industry Code has been developed to
minimise the risks to children posed by
ingestion of button batteries.
The TGA is currently investigating a report
submitted in August 2016 by the mother of a 16month-old child who had swallowed a button
battery dislodged from the hearing aid of another
child attending the same childcare centre.
When the centre workers noticed that the battery
was missing they contacted all parents and
advised them to take their children to hospital for
examination.
The child who swallowed the battery was identified
and eventually excreted it after spending two nights
in hospital being administered laxatives.
While this incident does not appear to have resulted
in lasting harm, such events are serious and
sometimes end in severe injuries or death.
In Australia, two children have died from button
battery-related injuries. An estimated 20 children
visit an emergency department each week for
removal or treatment of a swallowed or inserted
button battery.
Recommendations to reduce risks
Medical Devices Safety Update last reported on
this issue in July 2015. The Queensland Coroner
subsequently published the findings of an inquest
into the death of a four-year-old girl. The Australian
Competition and Consumer Commission (ACCC)
also published an Industry Code for Consumer
Goods that Contain Button Batteries on 29
July 2016. This Code was prepared by industry
representatives. Both the coroner and the Industry
Code make a number of recommendations aimed
at reducing the risk of death and life threatening
injuries to children from button battery ingestion.
The Industry Code recommends that suppliers
of consumer goods include readily available
safety features in their products such as battery
enclosures requiring the additional use of a tool
to gain access. The guidance in the Industry Code
is also suitable for medical devices that employ
button batteries. The TGA is considering options for
raising the awareness of the Industry Code among
manufacturers and suppliers of medical devices that
may use button or coin batteries.
You can help
If you treat a child after they have swallowed a
battery released from a medical device, become
aware of an event in which a child has been able
to access the battery compartment of a medical
device, or if you are using a medical device powered Medical Devices Safety Update
by a button battery that you feel may be too easily
is the medical devices safety
bulletin of the Therapeutic
accessible by a child, please submit a report to the
Goods Administration (TGA)
TGA.
For further information about reporting adverse
events, visit the Report a problem webpage on the
TGA website.
Full text free online at www.tga.gov.au
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Medical Devices Safety Update
Practice Points: Medical device Instructions
for Use documents can aid clinicians
Instructions for Use documents are important
components of medical devices and can aid
clinicians in a range of practice areas.
The TGA often suggests updates to the IFU
documents for devices to enhance safety and
ensure compliance with the standards.
A typical scenario
Instructions for Use (IFU) documents provide a
range of useful information for clinicians. Each
document usually lists the medical conditions for
which the device can be used, the intended patient
population and important possible adverse events
that the treating clinician can draw upon as a helpful
guide to ensure informed consent is established.
IFU documents are supplied with all medical
devices, as required under the Therapeutic Goods
(Medical Devices) Regulations 2002 (Schedule 1,
Subclause 13.4).
In addition to advice for pre-procedural
conversations, the IFU document can also
detail relevant instructions for troubleshooting
unexpected complications that a physician may
encounter when using the device, for example
during implantation.
The following hypothetical case highlights a
common type of adverse event reported to the TGA
and illustrates a scenario where the IFU document
was useful in resolving issues encountered during
device implantation:
•
a 65-year-old male was undergoing a vena
cava filter retrieval procedure via the femoral
access route
•
the clinician used a 7 French sheath
•
f ollowing multiple unsuccessful attempts to
capture the filter and retrieve it through the
7 French sheath, the sheath device buckled
and the tip was observed to have become
misshapen
•
member of the team used the theatre’s
a
computer to access the IFU document for the
filter device from the sponsor’s website
•
t he IFU indicated that retrieval should only be
performed using minimum 9F I.D./11F I.D. dual
retrieval sheaths
•
t he correct sheath size was sourced
immediately from the supply room
•
c apture was attempted with the correct sheath
size, and retrieval was successful
•
no patient complications occurred.
IFU documents usually include the following:
•
the manufacturer’s name and address
•
t he intended purpose of the device, the
intended user of the device, and the kind of
patient on whom the device is intended to be
used
•
risks arising from other equipment likely to be
present when the device is being used, such as
electro-surgical devices or MRI
•
possible adverse events and complications
•
c ontraindications, warnings, restrictions on use
and precautions
•
handling and storage requirements
•
information about sterility and whether the
device is intended for single use only
•
special operating instructions
•
training requirements or qualifications required
by the user
•
ow to use the device, and what to do when
h
difficulty is encountered using the device.
The IFU document is considered an important part
of a medical device and must comply with the
relevant standards.
Key points
•
An IFU document is part of a medical device
and is essential in enhancing the safety of the
device.
•
any IFU documents are available online, for
M
easy access during office procedures or in
the theatre environment. The TGA anticipates
that electronic versions of IFU documents will
become increasingly common in the future.
When searching for IFU documents online, it
can be helpful to search for both the device
name, and also use the search terms ‘Australian
version’.
•
If you review an IFU document and feel that
safety information could be improved, please
report this to the TGA.
Full text free online at www.tga.gov.au
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Medical Devices Safety Update
Software as a medical device: a summary
The widespread adoption of ‘smart
devices’ such as mobile phones has led to
a proliferation of health-related ‘apps’ and
software, some of which meet the definition
of medical devices and hence are subject to
TGA regulation.
With an ever increasing number of mobile apps
used to treat or diagnose conditions, many of these
will be covered by TGA regulation.
Products that are launched initially as general,
health or non-regulated software may become
of regulatory interest over time as new features
expand their functionality. For example, when a
simple blood glucose recording app on a smart
phone (which is not itself a medical device) adds
new features, it may eventually cross the threshold
to be classified as a medical device.
Some examples of relevant additional features
include:
•
bedside charting software that adds prompts
for limit violations
•
clinical information systems that add alerts
regarding clinical conditions
•
fitness trackers that add functions to diagnose
heart conditions.
When does software become
a medical device?
advertising material or any other documentation
provided with or about the software.
A software product is considered a medical
device if it fits the definition in section 41BD of the
Therapeutic Goods Act 1989. A medical device is
defined as:
a.
any instrument, apparatus, appliance,
material or other article (whether used alone
or in combination, and including the software
necessary for its proper application) intended,
by the person under whose name it is or is to be
supplied, to be used for human beings for the
purpose of one or more of the following:
1. diagnosis, prevention, monitoring,
treatment or alleviation of disease;
2. diagnosis, monitoring, treatment,
alleviation of or compensation for an injury or
disability;
3. investigation, replacement or modification
of the anatomy or of a physiological process;
4. control of conception;
and that does not achieve its principal
intended action in or on the human body by
pharmacological, immunological or metabolic
means, but that may be assisted in its function by
such means.
How does TGA regulate?
Many mobile apps have features and functions that
may push them close to the threshold of being a
medical device. A key question in determining the
likelihood of a piece of software being regulated
is to understand how far ‘up the scale’ the actual
application or use is. In many cases the software will
be in a grey zone and whether they are covered by
regulation will need to be determined on a case-bycase basis.
The TGA regulates medical device software that
meets the definition under the medical devices
regulatory framework. Both mobile apps and
standalone software are considered within this
framework. TGA regulation is risk-based and
depends on the intended purpose.
Software becomes a medical device when the
supplier intends for the software to be used in:
All medical devices are expected to meet the
required standards for safety and performance. For
further information, please refer to Section 13 in
Part 2 of the Australian Regulatory Guidelines for
Medical Devices (ARGMD).
•
diagnosis
•
prevention
•
monitoring
•
treatment or alleviation of disease.
The supplier’s intention can be ascertained
from statements made in labelling, instructions,
Manufacturers of medical device software products
(other than Class 1 - lowest risk) are required to
obtain Conformity Assessment certification.
Please report issues
The TGA encourages users of medical device
software to report any issues encountered.
Full text free online at www.tga.gov.au
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Medical Devices Safety Update
Recent safety alerts
Below are TGA safety alerts relating to
medical devices published since the last
edition of Medical Devices Safety Update.
PSA assay used with ADVIA Centaur systems:
Safety advisory - updating Instructions for Use
Molift Air ceiling hoist: Recall for product correction
- potential risk of injury due to bolt coming loose
Non-tuberculous mycobacterium infections
associated with heater-cooler devices: Alert
- updated advice for health professionals and
facilities following report of patient infection
Medela breastpumps detachable wall plug for AC
power adapter: Recall - risk of electric shock due to
breakage
Flocare Infinity enteral feeding pumps: Recall for
product correction - potential ‘air in line’ alarm
issues
Astral 100 and Astral 150 ventilators: Recall for
product correction - risk of loss of therapy due to
internal battery issue
Alere INRatio PT/INR monitor system: Update 2 Recall details
Urogynaecological surgical mesh complications:
TGA urges reporting of adverse events
Medtronic Neuromodulation Deep Brain Stimulation
system pocket adaptors: Hazard alert - risk of loss
of therapy due to electrical issue
Quickie Q7 manual wheelchair: Recall for product
correction - risk of backrest bracket breaking
James Leckey Design Mygo Stander: Recall for
product correction - small risk of injury due to
design of angle adjustment mechanism
What to report? Please report adverse events, as well as near misses
The TGA encourages the reporting of any
suspected adverse event or potential adverse
event relating to a medical device. Adverse
events can involve actual harm to a patient
or caregiver, or a near miss that may have
resulted in harm.
Some issues relating to medical devices that
may lead to adverse events and prompt you
to report include:
• device interactions
• user/systemic errors
Suspected adverse events or near misses can
be reported directly to the TGA:
• online at www.tga.gov.au (click ‘Report a
problem’)
• by emailing iris@tga.gov.au
For the latest information
from the TGA, subscribe
to the TGA Safety
Information email list via
the TGA website
For correspondence or
further information about
Medical Devices Safety
Update, contact the TGA’s
Medical Devices Branch at
iris@tga.gov.au or
1800 809 361
• mechanical or material failure
• by mail to IRIS, TGA, PO Box 100, Woden
ACT 2606
• design issues
• by fax to 02 6203 1713
Medical Devices Safety
Update is written by staff
from the Medical Devices
Branch
• labelling, packaging or manufacturing
deficiencies
For more information about reporting, visit
www.tga.gov.au or contact the TGA’s Medical
Devices Branch on 1800 809 361.
Editor:
Ms Pamela Carter
• software deficiencies
DISCLAIMER
Deputy Editor:
Mr Aaron Hall
The Medical Devices Safety Update (MDSU) is aimed at health professionals and is intended to provide practical information on medical devices safety,
including emerging safety issues. The information in the MDSU is necessarily general and is not intended to be a substitute for a health professional’s
judgment in each case, taking into account the individual circumstances of their patients. Reasonable care has been taken to ensure that the information
is accurate and complete at the time of publication. The Therapeutic Goods Administration gives no warranty that the information in this document is
accurate or complete, and does not accept liability for any injury, loss or damage whatsoever, due to negligence or otherwise, arising from the use of or
reliance on the information provided in this document.
TGA Principal Medical
Adviser:
Dr Tim Greenaway
© Commonwealth of Australia 2016
This work is copyright. You may reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an
organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any commercial purpose
and retain this copyright notice and all disclaimer notices as part of that reproduction. Apart from rights to use as permitted by the Copyright Act
1968 or allowed by this copyright notice, all other rights are reserved and you are not allowed to reproduce the whole or any part of this work in
any way (electronic or otherwise) without first being given specific written permission from the Commonwealth to do so. Requests and inquiries
concerning reproduction and rights are to be sent to the TGA Copyright Officer, Therapeutic Goods Administration, PO Box 100, Woden ACT 2606
or emailed to tga.copyright@tga.gov.au.
Contributors include:
Dr Cate Brogan
Dr Jorge Garcia
Dr Megan Hickie
Mr Patrick O’Meley
Full text free online at www.tga.gov.au
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