Medical Devices Safety Update

Medical Devices Safety Update (MDSU) provides health professionals with practical information and advice on medical device safety and information about emerging safety issues. The articles provide information on adverse event reporting and how health professionals can contribute to safety monitoring in Australia.

Articles are now published to our articles dataset as relevant topics arise.

This page is no longer being updated.

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2022 2021 2020 2019 2018 2017 2016 2015 2014 2013

2022

• Acellular dermal matrix products used in breast reconstruction
  20 January 2022 Requesting timely reporting of any adverse events associated with the use of acellular dermal matrix (ADM) products used in breast reconstruction surgery to help us assess if they are associated with higher complication rates in Australia.
• Limitations of pulse oximeters and the effect of skin pigmentation
  7 January 2022 Clinicians to be mindful of pulse oximeters accuracy, including in persons with darker skin.

2021

• The TGA response to ACCC safety and information standards
  15 June 2021 Consumer goods with button batteries

2020

• Programmable VT detection in cardiac resynchronisation therapy defibrillator (CRT-D) devices
  23 April 2020 Clinicians need to tailor the device programming of CRT-D devices to each patient to ensure the delivery of therapy
• Planning vital when using patient handling slings
  13 March 2020 Patient handling slings are a vital resource to make patient transfers safer for both staff and patients, but processes must be adhered to, in order to maintain skin integrity and prevent injury
• Consider the whole picture when testing troponin levels
  13 March 2020 Given the sensitivity of modern troponin tests, health professionals should be alert to the potential for false positive results and the associated risk of unnecessary patient treatment
• Surgical staplers: TGA reviews device incident reports
  13 March 2020 Health facilities and staff are reminded of the importance of following the Instructions for Use (IFU) for surgical staplers after the TGA reviewed Australian Device Incident Reports (DIRs) associated with the devices
• Updated cleaning instructions for long-term nasogastric tubes
  13 March 2020 Changes to the cleaning instructions for long-term nasogastric tubes have been implemented following a TGA investigation into reports of leaking tubes and connector strap breakages
• Acrylonitrile butadiene styrene incompatible with anaesthetic spray
  13 March 2020 Ethyl chloride spray should not be used in association with medical devices containing a common plastic

2019

• Paclitaxel-coated products used in the peripheral arteries
  12 August 2019 Medical device regulators around the world are reviewing incidents associated with paclitaxel-coated products following the publication last December of a meta-analysis of randomised controlled trials in the Journal of the American Heart Association (JAHA)

2018

• Medical Devices Safety Update, Volume 6, Number 6, November 2018
  Standards minimise risk of misconnections; eltrombopag interference with test results; amniotic fluid tests
• Medical Devices Safety Update, Volume 6, Number 5, September 2018
  Case studies in Incident Report Investigations; review of reusable biopsy forceps devices; care required with patient lifters
• Medical Devices Safety Update Volume 6, Number 4, July 2018
  Be aware of cross-reactivity with home-use self-test ovulation kits, TGA undertakes product safety review into intragastric balloon systems
• Medical Devices Safety Update Volume 6, Number 3, May 2018
  Joint replacement registry data; Focus on skills for vacuum-assisted births; TGA reviews product safety of ventilators
• Medical Devices Safety Update Volume 6, Number 2, March 2018
  Preventable alarm issues; cochlear implants and MRIs; NHS cylinder alert; recent safety alerts
• Medical Devices Safety Update, Volume 6, Number 1, January 2018
  Inappropriate use of scalpel removers; ransomware named as 2018's 'top hazard'; joint registry data; recent safety alerts

2017

• Medical Devices Safety Update, Volume 5, Number 6, November 2017
  TGA acts to improve button battery safety; Patient education vital for infusor use; Gas cylinder pressure regulators warning; Recent safety alerts
• Medical Devices Safety Update, Volume 5, Number 5, September 2017
  Requirements when supplying medical device accessories and consumables; Attention to device design can play an important role in minimising user errors; Zimmer safety alert reminds surgeons 'once ceramic, always ceramic'; TGA encourages reporting of incidents involving the use of surgical staplers
• Medical Devices Safety Update, Volume 5, Number 4, July 2017
  Warning on IV solution bags; Zoll upgrade counters clock drift; Hysteroscope cleaning advice updated; Mitroflow valves; Recent safety alerts
• Medical Devices Safety Update, Volume 5, Number 3, May 2017
  Study looks at vascular closure device; Disinfectants can damage medical equipment; Stryker advice for surgeons; Recent safety alerts
• Medical Devices Safety Update, Volume 5, Number 2, March 2017
  Recall documentation vital; Practice Points: Topical creams as devices; New committee takes over from ACSMD
• Medical Devices Safety Update, Volume 5, Number 1, January 2017
  TGA encourages formal strategies for inferior vena cava filter removal; ECRI lists infusion errors as top 2017 hazard; Recent safety alerts

2016

• Medical Devices Safety Update, Volume 4, Number 6, November 2016
  Insights into orthopaedic implants; Standard improves heat pack safety; Practice points: Postoperative monitoring; Recent safety alerts
• Medical Devices Safety Update, Volume 4, Number 5, September 2016
  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
• Medical Devices Safety Update, Volume 4, Number 4, July 2016
  TGA tests resolve potential issue with intravenous catheter connection; Recent safety alerts; Practice Points: The 'doctor's bag'; Adverse event reporting compliance
• Medical Devices Safety Update, Volume 4, Number 3, May 2016
  TGA urges reporting of contamination after reprocessing of endoscopes; Non-tuberculous mycobacterium infections associated with heater-cooler devices; Free CPD modules; Recent safety alerts
• Medical Devices Safety Update, Volume 4, Number 2, March 2016
  Endoscope reprocessing; Device cybersecurity a key issue; Safely retaining devices; Sponsor workshops; Recent safety alerts
• Medical Devices Safety Update, Volume 4, Number 1, January 2016
  Battery management a growing issue; Safety alerts issued for two knee implants; IUCDs and uterine perforation; Recent safety alerts; inSite program extends to Sydney

2015

• Medical Devices Safety Update, Volume 3, Number 6, November 2015
  Joint registry data offers insight into Australian orthopaedic implants; Reports highlight reprocessing issues; 'Mild' hyperbaric chambers cancelled; Recent safety alerts
• Medical Devices Safety Update, Volume 3, Number 5, September 2015
  Check 'synch' before cardioversion; Recognising medical device incidents; Grounding pad selection vital during electrosurgical and ablation procedures; Practice points - HIV point-of-care testing; Recent safety alerts
• Medical Devices Safety Update, Volume 3, Number 4, July 2015
  Action after registry data analysis; Environmental extremes; Button battery dangers; Infant sleep positioners reviewed
• Medical Devices Safety Update, Volume 3, Number 3, May 2015
  Retain medical devices associated with adverse event reports; TGA laparoscopic morcellator review; Practice points - pleural catheters; Recent safety alerts
• Medical Devices Safety Update, Volume 3, Number 2, March 2015
  Caution advised in choosing intravenous catheters if power injection may be required; Acanthamoeba keratitis risk for contact lens users; The TGA thanks you for your medical device adverse event reports; Recent safety alerts
• Medical Devices Safety Update, Volume 3, Number 1, January 2015
  Safety though adverse event reporting; Recommendations for avoiding or dealing with surgical implant tool breakages; IRIS inSite pilot off to promising start; Clinical alarm issues still pose top hazard; Recent safety alerts

2014

• Medical Devices Safety Update, Volume 2, Number 6, November 2014
  Urogynaecological surgical mesh implants review; Latest National Joint Replacement Registry data offers insight into orthopaedic implants; Recent safety alerts; Warning - incidents relating to use of walking frames as wheelchairs
• Medical Devices Safety Update, Volume 2, Number 5, September 2014
  Risk of electric shock during defibrillator check; Endoscopes reprocessing procedures; Recent safety alerts; Following Instructions for Use and maintenance key to safe use of slings and patient lifters
• Medical Devices Safety Update, Volume 2, Number 4, July 2014
  Reducing the risks associated with infusion pumps; Accu-Chek Multiclix not for use on multiple people; Introducer/bougie instructions reminder; Recent safety alerts; How you can contribute to the regulation of medical devices
• Medical Devices Safety Update, Volume 2, Number 3, May 2014
  Alarm hazards - user error a common contributing factor; Adjustments to plunger forces for new BD 50 ml Plastipak syringes; Recent safety alerts
• Medical Devices Safety Update, Volume 2, Number 2, March 2014
  TGA tests ultrasound transmission gels for bacterial contamination; Searchable recall action database available online; Remind patients of flame dangers while using oxygen concentrators; Adverse events lead to review of surgical gauze with X-ray detectable strips; Index of suspicion: assessing accuracy and predictive value in testing
• Medical Devices Safety Update, Volume 2, Number 1, January 2014
  Alarm problems a top health technology hazard; Strategies for preventing intravenous and epidural misconnections; Speedstitch suturing device

2013

• Medical Devices Safety Update, Volume 1, Number 1, November 2013
  Riata and Riata ST silicone cardiac leads update; Correct use of blood collection packs - spiking; Frova intubating catheter/introducer