Medical Devices Safety Update Volume 5, Number 6, November 2017
Medical Devices Safety Update is the medical device safety bulletin of the Therapeutic Goods Administration (TGA)
In this issue
TGA acts to improve button battery safety
The Therapeutic Goods Administration has directly contacted 175 medical device sponsors regarding potential safety issues associated with the use of button batteries in their products.
In recent years there have been several incidents of Australian children swallowing button batteries, resulting in serious injuries and fatalities. MDSU reported on the issue in July 2015 and September 2016. The Australian Competition and Consumer Commission (ACCC) published an industry code in July 2016 to minimise the risks to children posed by the ingestion of button batteries contained within consumer goods. This industry code makes several recommendations regarding the safety features of these products including: how the battery is stored in the device, how readily accessible the battery is, and issues around safety label management. The code is applicable for medical devices powered by button batteries.
The ACCC and other groups have also been running the Battery Controlled Campaign since 2012. This campaign identified that 8% of injuries associated with children under the age of four swallowing batteries involved batteries associated with hearing aids.
The TGA sought advice from the Advisory Committee on the Safety of Medical Devices in September 2016 on how best to raise awareness of button battery safety. It was decided the best way to achieve this goal was by contacting relevant sponsors directly and asking them to undertake a self-assessment. The TGA wrote to certain sponsors introducing the issue and detailing the importance of responding. The TGA also distributed self-assessment information developed by the ACCC. This allowed sponsors to ascertain if they were compliant with the industry code as well as the Essential Principles contained within the Australian regulatory guidelines for medical devices. If a sponsor (or device) was not compliant, they were directed to formulate alternative risk-abatement measures and return their results to the TGA.
he material was sent to sponsors of digital thermometers, blood glucose meters and hearing aids powered by button batteries. These sponsors were chosen due to their greater likelihood of being used in a home environment, where children may interact with such devices.
In total, 175 sponsors were contacted. As of 25 August 2017, 116 responses had been received. Of these, about 40 sponsors reported that their device was not powered by button batteries. Additionally, a further five reported that their device was only used in a clinical or hospital setting. Of the remaining 71 sponsors, 35 were required by the self-assessment to detail alternative risk abatement measures.
The next steps in this process will include TGA analysing the alternative risk measures to determine if such measures are acceptable. We are also re-contacting those sponsors that have not initially responded.
Patient education vital for infusor use
A range of factors can influence the infusion and flow rates encountered when using elastometric infusors.
The TGA has received two Device Incident Reports relating to under-infusion issues and slower-than-expected flow rates for chemotherapy treatment associated with the Baxter Folfusor elastomeric infusion pump system. The two reports were submitted by health facilities and relate to 14 incidents in total.
The Baxter devices can be used to infuse a range of medications other than chemotherapy and can be used over several days outside of the hospital/clinic environment. A root cause was not determined for the under-infusion. TGA has confirmed with the sponsor that no device manufacturing issues were identified. The sponsor believed it was likely that most under-infusion incidents occurred during unsupervised use and out of the health-care environment (e.g., in patient's homes).
Variables affecting flow rates
The Baxter Folfusor Instructions for Use (IFU) state the nominal flow rate is +/- 10% when the device is filled within the minimum and maximum fill volume.
The IFU also lists other variables that can affect flow rates and infusion times:
- Temperature - nominal flow rate is achieved at a temperature of 33.3 degrees C. For every 1 degree difference below this the flow rate can be reduced by up to 2.3%. The IFU and instructional information advise that the distal tubing should be attached directly to the patient skin to achieve the desired medication temperature.
- Fluid type - different fluid viscosity can either speed up or slow down the flow rate.
- Impact of head height - the device is designed to operate at the nominal flow rate when the fill port is at the same level as the distal end luer lock/flow restrictor. For every 2.54 cm difference in height the flow is affected by 0.5%.
- Impact of catheter size - nominal flow rate is achieved when used with 22 Gauge (3 French or larger) catheters.
- Fill point of the device - over-filling or under-filling will impact the nominal flow rate. Fill parameters and instructions are listed in the IFU.
Ensure patient is informed
The Baxter Folfusor IFU provides information for the patient and the health-care provider in the use of the device covering:
- operating conditions;
- warnings; and
- directions for use.
It is important for health practitioners to understand the correct use of the device, its limitations and potential for variability in flow and infusion times and to discuss these factors with patients. The discussion needs to cover the importance of following the IFU and an awareness of the effects of variables such as temperature and positioning of the device. These factors can be monitored and controlled by patients.
Health professionals and patients can contact Baxter for additional information and support by telephoning 1300 302 409.
Gas cylinder pressure regulators warning
The industry body covering hospital gas suppliers has warned about an issue with some gas cylinder pressure regulators.
The Australia New Zealand Industrial Gas Association has issued a safety alert regarding rare failures with some gas cylinder pressure regulator gauges (pdf,591kb) which may not be obvious to users.
Hospital medical gas systems are boundary products in that the gasses and cylinders are classed as medicines while the gauges and regulators are classed as medical devices, thus being covered by different areas of TGA's jurisdiction. If you encounter a problem with a gauge or regulator please report the issue using the medical device reporting channel.
The TGA does not currently have any adverse event reports for this issue in its Incident Reporting and Investigation Scheme database and we encourage anyone encountering such issues to report them to us and the sponsor.
Recent safety alerts
Below are TGA safety alerts relating to medical devices published since the last edition of Medical Devices Safety Update.
Permobil powered wheelchairs - Corpus II seating system: Recall for product correction - potential for injury due to breakage of the seating system
Surflink Media and Surflink Media 2 (Models 200 and 210) - used with wireless hearing aids: Recall for product correction - may cause interference with mobile towers
Freedom Healthcare Quad Walkers: Recall - potential for injury as a result of breakage
Puritan Bennet 980 Series Ventilator: Suspension of supply - user interface failures and inadequate ventilation specifications
Medtronic MiniMed infusion sets: Recall - potential for over-delivery of insulin and risk of hypoglycaemia
Breast implants and anaplastic large cell lymphoma: Update - additional confirmed cases of anaplastic large cell lymphoma
Platinium ICDs and CRT-Ds: Hazard alert - potential for reduced device longevity
Essure contraceptive device: Hazard alert - labelling update relating to potential risks
Gadolinium-based contrast agents for MRI scans: Safety advisory - potential retention in the brain but no known adverse effects
NovoPen Echo insulin injection pen: Recall - risk of cracking or breaking that could affect dosing
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:
- online at Report a problem
- by emailing email@example.com
- 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 Medical Devices 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.
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For correspondence or further information about Medical Devices Safety Update, contact the TGA's Medical Devices Branch at email@example.com 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 Chief Medical Adviser: Adjunct Professor Tim Greenaway
Contributors include: Mr Mark Stafford-Bell, Mr Allen Bates