Medical Devices Safety Update, Volume 4, Number 5, September 2016

6 September 2016

Medical Devices Safety Update is the medical device safety bulletin of the Therapeutic Goods Administration (TGA)

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 16-month-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 Device 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 (pdf,1Mb). 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 by a button battery that you feel may be too easily accessible by a child, please submit a report to the TGA.

For further information about reporting adverse events, visit the Report a problem web page on the TGA website.

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.

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.

IFU documents usually include the following:

  • the manufacturer's name and address
  • the 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
  • contraindications, 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
  • how to use the device, and what to do when 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.

The TGA often suggests updates to the IFU documents for devices to enhance safety and ensure compliance with the standards.

A typical scenario

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
  • following 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
  • a member of the team used the theatre's computer to access the IFU document for the filter device from the sponsor's website
  • the IFU indicated that retrieval should only be performed using minimum 9F I.D./11F I.D. dual retrieval sheaths
  • the correct sheath size was sourced immediately from the supply room
  • capture was attempted with the correct sheath size, and retrieval was successful
  • no patient complications occurred.

Key points

  • An IFU document is part of a medical device and is essential in enhancing the safety of the device.
  • Many IFU documents are available online, for 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.

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?

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-by-case basis.

Software becomes a medical device when the supplier intends for the software to be used in:

  • diagnosis
  • prevention
  • monitoring
  • treatment or alleviation of disease.

The supplier's intention can be ascertained from statements made in labelling, instructions, 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:

  1. 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?

The TGA regulates medical device software that meets the definition under the medical devices regulatory framework. Both mobile apps and standalone software would be considered within this framework.

TGA regulation is risk-based and depends on the intended purpose.

Manufacturers of medical device software products (other than Class 1 - lowest risk) are required to obtain Conformity Assessment certification.

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).

Please report issues

The TGA encourages users of medical device software to report any issues encountered.

Recent safety alerts

Below are TGA safety alerts relating to medical devices published since the last edition of Medical Devices Safety Update.

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:

  • mechanical or material failure
  • design issues
  • labelling, packaging or manufacturing deficiencies
  • software deficiencies
  • device interactions
  • user/systemic errors.

Suspected adverse events or near misses can be reported directly to the TGA:

For more information about reporting, visit www.tga.gov.au or contact the TGA's Medical Devices Branch on 1800 809 361.

Disclaimer

The Medical Devices Safety Update (MDSU) is aimed at health professionals and is intended to provide practical information on medical device 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.

© 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 .


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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.


Medical Devices Safety Update is written by staff from the Medical Devices Branch.

Editor: Ms Pamela Carter

Deputy Editor: Mr Aaron Hall

TGA Principal Medical Adviser: Dr Tim Greenaway

Contributors include: Dr Cate Brogan, Dr Jorge Garcia, Dr Megan Hickie, Mr Patrick O'Meley