Medical Devices Safety Update, Volume 3, Number 4, July 2015
Medical Devices Safety Update is the medical device safety bulletin of the Therapeutic Goods Administration (TGA)
In this issue
- TGA takes action after analysis of orthopaedic registry data
- Environmental extremes create additional hazards for some medical devices
- Dangers for children from button batteries used in devices such as hearing aids
- Infant sleep positioners and pillows review
- Recent safety alerts
- TGA databases
- What to report? Please report adverse events, as well as near misses
TGA takes action after analysis of orthopaedic registry data
The TGA has recently undertaken a range of actions involving hip, knee and shoulder orthopaedic implants that have been identified as having higher-than-expected rates of revision.
Details of the Australian Orthopaedic Association's National Joint Replacement Registry (AOANJRR) 2014 annual reports were published in the November 2014 issue of Medical Devices Safety Update.
Nineteen implant combinations with higher-than-expected revision rates were newly identified in the 2014 annual reports, which drew data from the period 1 September 1999 to 31 December 2013 and were published on 1 October 2014.*
TGA review process
Analysis of AOANJRR annual reports, together with review of internal adverse event reports, forms a key part of the TGA's routine monitoring of the safety of orthopaedic implants.
As part of this process, the TGA seeks advice from the Orthopaedic Subcommittee (OSC) of its Advisory Committee on the Safety of Medical Devices (ACSMD) regarding whether the revision rates reported by the AOANJRR are of significant clinical concern.
Of the 19 newly identified implant combinations outlined in the 2014 annual reports, four had already been withdrawn from the market and one had been cancelled from the Australian Register of Therapeutic Goods (ARTG) in October 2012. The TGA contacted the sponsors of the remaining implant combinations requesting responses to concerns raised by the AOANJRR data.
The AOANJRR data and sponsor submissions, together with TGA analysis, were then referred to the OSC on 8 December 2014, and again on 30 March 2015.
Recent regulatory intervention
Orthopaedic implants are revised for a variety of reasons and therefore regulatory intervention is not necessary for every implant that is identified as having a higher-than-expected rate of revision. When regulatory intervention is necessary, all surgeons who have used the implant combinations are advised through a hazard alert and details of the safety problem are published on the TGA website.
Since publication of the AOANJRR 2014 annual reports, TGA intervention has led to the following implant combinations being subject of an alert, and in some cases also being cancelled from the ARTG:
There was also an alert regarding the Score Knee Prosthesis, which was first identified as having a higher-than-expected revision rate in 2013.
The TGA continues to observe and/or investigate implants combinations identified by the AOANJRR. The TGA will take further regulatory action when required and will publish information for health professionals and consumers if new safety problems are identified.
Joint replacement surgery is considered to be one of the most effective forms of surgical intervention and rates of revision are generally low, even for many of the implant combinations identified by the AOANJRR. Also, there are many reasons why a particular implant may be having a higher-than-expected rate of revision (including patient-related factors such as age and level of activity), therefore not all such implants require regulatory intervention.
The November 2014 MDSU article incorrectly reported that 18 implant combinations with higher-than-expected revision rates were newly identified in the 2014 AOANJRR annual reports. The number was in fact 19.
Environmental extremes add additional hazards for some medical devices
With many parts of Australia subject to extreme environmental conditions, health professionals and health facilities are advised to be alert to risks such as extreme heat and dust and take steps to mitigate their impact on medical devices.
Twenty-three medical device-related adverse event reports made to the TGA since 2011 have specifically attributed environmental conditions as the cause of the problem. Of these, two were serious adverse events with five others being temporary.
Issues have occurred in a wide variety of devices including in vitro diagnostic medical devices (blood collection vessels, tubes and pregnancy tests), dialysis filters, dermal fillers and grommets.
Heat and dust the main issues
The two main environmental issues reported as underlying causes of adverse events are heat and dust.
Many devices are sensitive to temperature extremes. As extreme heat is common across much of Australia, those responsible for transport and storage of such devices should be alert to the potential effects.
Some situations such as use and storage of medical devices in ambulances can pose particular challenges. In July 2014, MDSU reported an issue with an introducer/bougie that had been stored in an ambulance in which exposure to extreme heat may have played a role in the adverse event.
Dust is also widespread across much of Australia and poses potential contamination challenges, particularly during transport and storage of medical devices.
Recommendations for health professionals and health facilities
The TGA advises health professionals to:
- be alert to the potential for environmental conditions to affect the quality, safety and performance of medical devices
- consider what environmental conditions affect your working environment and/or transport chain and act to mitigate the risks
- familiarise yourselves with the Instructions for Use for medical devices that you use and be alert to references to the potential effects of environmental conditions
- report issues with medical devices to the sponsor and/or TGA.
Dangers for children from button batteries used in devices such as hearing aids
The Australian Competition and Consumer Commission (ACCC) has undertaken a campaign to reduce the dangers posed to young children from button batteries used in hearing aids and a range of other products.
The Battery Controlled campaign has identified that about 8% of injuries caused by children under the age of four swallowing batteries involve batteries associated with hearing aids.
Injury reports indicate that in most instances where children swallow batteries associated with hearing aids, the children have removed the battery unnoticed or their carers have left the battery unsecured without recognising the significant danger it poses to young children. This danger is heightened in situations where it is unusual to have young children around where these batteries are being used and awareness of the problem is low.
About 7% of injuries in children under that age of four are associated with batteries obtained from toys. Other major sources of button batteries are remote controls, musical greeting cards and disposable novelty items.
To help reduce the risk, toys for children under 36 months are required to have secured battery compartments.
Button batteries are attractive to young children who like to put things in their mouths. Serious complications can develop in two hours if the battery is not detected and removed promptly. Death is possible within 24 hours.
Almost half of reported cases are misdiagnosed as symptoms appear flu-like and in X-rays a button battery can look like a coin, which might otherwise be safe to leave to pass through. There are an estimated five admissions to Australian hospitals weekly, with at least 11% of these incidents resulting in serious injuries. In 2013 a four-year-old Queensland girl died as a result of swallowing a button battery.
Working with industry
The ACCC is working closely with suppliers of button batteries and products that use button batteries to reduce the dangers these batteries present to young children.
The ACCC is encouraging industry to provide safety warnings with hearing aids, their packaging and any batteries provided, along with ensuring that hearing aids are made with secure battery compartments.
For guidance on how to make products safer and recommended safety warnings contact the ACCC’s Product Safety Branch directly on email@example.com.
TGA encourages reporting
Apart from hearing aids, button batteries are used in wide variety of medical devices.
The TGA encourages health professionals and consumers to report incidents and injuries associated with these products, and all other medical devices.
For further information about reporting adverse events, visit the Report a problem webpage on the TGA website.
Infant sleep positioners and pillows review
The TGA has completed a post-market review of infant sleep positioners and pillows following a complaint.
The TGA undertook a post-market review of infant sleep positioners and pillows after a complainant reported that they conflicted with safe sleeping guidelines and could lead to infant deaths.
Infant sleep positioners and pillows are sometimes promoted for preventing or resolving plagiocephaly, or flat-head syndrome. This is a serious medical condition and the risk from a delay to diagnosis/seeking medical advice might have grave consequences.
The remaining devices were reviewed to ensure that they were safe for use, the indicated medical claims could be substantiated and that the requirements for compliance with the required evidence standards of the Australian Regulatory Guidelines for Medical Devices.
The TGA cancelled the remaining three products from the ARTG due to non-compliance with the required evidence standards and notices were published on the TGA website.
The TGA encourages health professionals to report products that are potentially unsafe, make unsubstantiated medical claims or conflict with the required evidence standards. The TGA has an online reporting form at Report a problem.
Recent safety alerts
Below are TGA safety alerts relating to medical devices published since the last edition of Medical Devices Safety Update.
Medtronic MiniMed Sure-T infusion sets: Recall for product correction - Potential for interruption of insulin delivery and/or infection as a result of the needle breaking during use.
Philips devices that use auto servo ventilation therapy: Recall for product correction - increased risk of death for patients with symptomatic chronic heart failure.
Birmingham Hip Resurfacing system: Update regarding new hazard alert and recall of certain components due to increased risk of revision surgery for some patients.
ResMed devices that use Adaptive Servo-Ventilation therapy: Additional device affected by previous recall action relating to increased risk of death for patients with symptomatic chronic heart failure.
The TGA communicates its monitoring and evaluation of information related to the safety and efficacy of marketed therapeutic products through a variety of means, including via two publicly searchable databases, the Database of Adverse Event Notifications (DAEN) and the System for Australian Recall Actions (SARA).
Information in DAEN comes from reports made to the TGA by a wide range of sources, including sponsors, health professionals and consumers.
Reports received by the TGA up until three months prior to the date of access are available from the database. The TGA uses this three-month period to investigate each adverse event report.
SARA provides health professionals, sponsors, wholesalers, hospitals, retailers and consumers with access to information about recall actions occurring in Australia for therapeutic goods.
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:
- online at Report a problem
- by emailing firstname.lastname@example.org
- by mail to IRIS, TGA, PO Box 100, Woden ACT 2606
- by fax to 02 6203 1713.
For more information about reporting, visit www.tga.gov.au or contact the TGA's Post-market Surveillance Branch on 1800 809 361.
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 2015
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For correspondence or further information about Medical Devices Safety Update, contact the TGA's Post-market Surveillance Branch at firstname.lastname@example.org or 1800 809 361.
Medical Devices Safety Update is written by staff from the Post-market Surveillance Branch.
Editor: Dr Katherine Gray
Deputy Editor: Mr Aaron Hall
Acting TGA Principal Medical Adviser: Dr Tony Gill
Contributors include: Ms Sharon Bennett, Dr Amanda Craig, Dr Jorge Garcia