Medical Devices Safety Update, Volume 3, Number 1, January 2015
Medical Devices Safety Update is the medical device safety bulletin of the Therapeutic Goods Administration (TGA)
In this issue
- 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
- What to report? Please report adverse events, as well as near misses
Safety though adverse event reporting
The TGA, in partnership with NPS MedicineWise, has launched two online learning modules to support health professionals in reporting adverse events.
The TGA and NPS Medicinewise have worked together to create two interactive online learning modules designed to improve health professional adverse event reporting for medical devices, medicines and vaccines.
The modules, located at NPS website - Safety through Adverse Event Reporting, encourage health professionals to actively participate in continuous safety monitoring by identifying, documenting and reporting adverse events, as well as promote a culture of adverse event reporting in the healthcare setting.
Given their expertise and direct contact with patients, health professionals are among those best placed to provide high-quality adverse event reports. These reports are critical to ensuring the TGA can formally respond to potential threats to patient safety.
Module 2 is about reporting adverse events relating to medical devices, and targets nurses and other health professionals working in hospitals, including biomedical engineers, while module 1 focuses on reporting adverse events involving medicines and vaccines.
On completion of module 2 health professionals should be able to:
- explain the importance of post-marketing surveillance in ensuring medical devices are safe and effective, and describe their role in post-marketing safety activities such as adverse event reporting
- identify which adverse events require reporting and describe the reporting process for medical devices
- complete an adverse event report and explain why the requested information is important for the TGA
- summarise the regulatory system for reporting adverse events associated with medical devices and explain how this differs to that for medicines
- implement a reporting system for their practice based on what they have learnt in the module.
The modules are accredited for Continuing Professional Development points with the Royal Australian College of General Practitioners, the Australian College of Rural and Remote Medicine, the Australian College of Nursing and the Pharmaceutical Society of Australia.
Recommendations for avoiding or dealing with surgical implant tool breakages
The TGA regularly receives reports of surgical tools breaking while being used in association with implant surgery, including orthopaedic, oral and maxillofacial surgery.
The TGA received 37 reports of surgical tools and fixation aids breaking while being used in association with implants between July 2012 and August 2014.
'Stuck' screws a common cause
Reports to the TGA indicate that implant surgical tool breakages are often associated with attempting to turn screws that appear to be stuck. The force subsequently applied can cause breakage.
Screws may be difficult to turn if:
- the wrong tool is being used
- there is a mechanical inhibition (for example, screw is blocked or already locked in place by another component)
- there is damage to the threads
- there is a foreign substance (for example, tissue, blood) in the threads
- high-speed processes such as power tools have been used on aluminium alloy nuts/screws during the procedure (this may create damage to the metal-on-metal contact surfaces though 'galling').
Visible rust or delamination are important warning signs
Breakages are also often reported to be associated with visible rust or delamination of the tool surface.
Rust is an indicator of likely internal damage and weakening of the tool. If a tool has rusted it should not be used.
Rust can be caused by the sterilisation process (for example, stainless steel tools being sterilised in aluminium trays can create rust patches in the steel) and it is also accelerated by damage to the surface of the tool.
Torque indicators advised
Surgical tools have limited design strength and torque limits are often specified in the Instructions for Use (IFU).
It is recommended for health professionals to use tools in conjunction with torque indicators when limits are specified in the IFU.
When to replace a tool
Tools have finite life and should be replaced:
- according to a maintenance schedule (follow the manufacturer's IFU recommendation - this may mean keeping track of tools on permanent loan or retaining 'age' information when supplying or borrowing tools)
- when rust is visible
- when damaged (bent, chipped and so on).
Health facilities are advised to institute an inspection/maintenance regime for surgical tools.
What if a tool breaks?
If a tool breaks be aware that:
- the incident may have created sharp shards of metal that can fall into a wound and be difficult to find/retrieve
- sharp edges can pose a puncture hazard
- tool fragments may remain on screw heads.
If there is any suspicion that some fragments have not been recovered, health professionals should try to reassemble the tool to gauge whether pieces may still be missing and, if so, take appropriate action.
Recommendations for health professionals
The TGA advises health professionals to:
- read and follow the IFU during use, cleaning, and sterilisation
- avoid using excessive force - ask the question, 'Am I using the correct tool and using it the correct way?'
- report tool breakages to the sponsor and/or TGA.
IRIS inSite pilot off to promising start
The TGA has launched IRIS inSite, a pilot project to study how communicating directly with health professionals in a hospital setting can improve the rate and quality of medical device adverse event reporting.
Two ACT hospitals, the Canberra Hospital and National Capital Private Hospital, are taking part in the IRIS inSite pilot, which seeks to remove barriers to adverse event reporting, improve awareness of reporting mechanisms among health professionals and cement ongoing links between the pilot sites and the TGA.
Reports received through IRIS inSite are analysed to identify potential emerging problems for detailed investigation.
To be as effective as possible in finding safety signals, the TGA relies on receiving a sufficient volume of high quality data.
Some of the highest quality data comes from health professionals reporting adverse events directly to the TGA and the IRIS inSite project aims to promote this channel.
Similar projects in the United States, Canada and the United Kingdom have demonstrated that, when the regulator establishes a direct relationship with a health facility, it increases both the quantity and quality of adverse event reports received by the regulator.
The TGA is working closely with both hospitals, running education sessions across key clinical units and raising awareness of what and how to report. By the end of 2014, more than 20 sessions had been delivered.
Recognise, retain and report
As part of the project, presentations to health professionals reinforce the key messages of 'Recognise' (what is a medical device, what is a medical device event, how do I report), 'Retain' (keep the device and its packaging until you find out whether the TGA needs to examine it) and 'Report' (you don't have to be certain, just suspicious).
These presentations also include case studies and some striking statistics about current reporting.
There are several recognised barriers to adverse event reporting, including:
- a lack of awareness among health professionals that they can and should report adverse events to the TGA and a lack of understanding about the importance and impact of these reports
- uncertainty about what should be reported and how to report
- an existing heavy reporting burden, including internal incident management systems, professional associations, registries and coroners.
IRIS inSite aims to address several of these barriers.
Participants in the education sessions have the opportunity to engage in discussions with both a TGA representative and hospital management about reporting, their perceptions and ways to overcome barriers.
The IRIS inSite project aims to demonstrate that working closely with health facilities to educate health professionals has a positive impact on the frequency, rate and quality of reports received and consequently TGA's ability to safeguard the use of therapeutic goods in Australia. The project complements TGA's online reporting initiatives for all health professionals, including new education modules and reporting options.
The IRIS inSite project will run until the end of the year, followed by a three-month evaluation period undertaken with a view to extending the service to other health facilities.
Clinical alarm issues still pose top hazard
Clinical alarm issues remain the top health technology hazard worldwide, followed by data integrity issues and IV line misconnections.
Clinical alarm issues have again topped the list as the number one health technology hazard worldwide for 2015, according to the Emergency Care Research Institute (ECRI).1
MDSU addressed the issue of clinical alarm hazards from an Australian perspective in an article in the May 2014 edition.
Clinical alarm hazards also topped the ECRI list in 2012, 2013 and 2014 and placed high in prior rankings.
ECRI's top 10 hazards list for 2015 is:
- Alarm hazards: Inadequate alarm configuration policies and practices (an MDSU article discussed this issue in May 2014)
- Data integrity: Incorrect or missing data in electronic health records and other health IT systems
- Mix-up of IV lines leading to misadministration of drugs and solutions (an MDSU article discussed this issue in January 2014)
- Inadequate reprocessing of endoscopes and surgical instruments (an MDSU article discussed this issue in September 2014)
- Ventilator disconnections not caught because of mis-set or missed alarms
- Patient-handling device use errors and device failures (an MDSU article discussed this issue in September 2014)
- "Dose creep": Unnoticed variations in diagnostic radiation exposures
- Robotic surgery: Complications due to insufficient training
- Cybersecurity: Insufficient protections for medical devices and systems
- Overwhelmed recall and safety alert management programs within hospitals.
Focus on solutions
The TGA advises health professionals to consider ways to mitigate risks within the clinical settings in which they work.
Health facilities should:
- set up effective risk management programs that involve clinicians, biomedical engineers, hospital management and administrative staff
- ensure that responsibilities are clearly assigned to the relevant personnel
- ensure all staff carefully read and fully understand the Instructions for Use for devices they use and are responsible for.
- apply usability and ergonomic principles in the design and construction of their devices to assure their devices comply with quality and safety requirements
- ensure that the Instructions for Use be clearly written and that user education is appropriately designed and effectively conducted.
Both health facilities and manufacturers have the responsibility to establish effective communication systems to reduce adverse events.
- Top 10 Health technology Hazards for 2015, Health Devices, volume 2, number 6, November 2014. Emergency Care Research Institute
Recent safety alerts
The TGA publishes alerts on its website when there is new safety information regarding therapeutic products.
Below are TGA safety alerts relating to medical devices published since the last edition of Medical Devices Safety Update.
St Jude implantable devices when used with the Merlin@home transmitter: St Jude Medical issued a hazard alert for some of its implanted devices due to the potential for unintended implanted device software reset.
Affinis Fracture ceramic head (used in shoulder replacements): Mathys Orthopaedics issued a hazard alert and recall for product correction to update the Instructions for Use and Surgical Technique documents to reduce the risk of inadequate fixation
Fluoron EasyGas tamponades: IQ Medical issued a safety alert after a mislabelling issue which may require patients to extend the period of caution regarding air pressure variations.
EndoBarrier gastrointestinal liner with delivery system: Emergo Australia issued a hazard alert and recall for product correction to update the Instructions for Use to mitigate risks of multiple adverse events.
Lentis HydroSmart intraocular lenses (supplied in glass vials): Device Technologies Australia issued a hazard alert and a recall for affected lenses due to the potential for lenses to lose transparency.
Alere INRatio PT/INR monitor system: Alere, in consultation with the TGA, has initiated a recall for product correction for its Alere INRatio PT/INR monitor system due to the potential for incorrect INR results
Sirius Hip Stem 34B and 38C: Biomet Australia issued a hazard alert regarding two batches due to a component mix-up that could potentially lead to increased risk of revision.
Trilogy bone screws: Zimmer issued a hazard alert and recalled some lots due to a manufacturing fault that could lead to increased potential to fracture.
St Jude Medical implantable neurostimulators and accessories: The TGA has issued a hazard alert advising that occipital nerve stimulation for the treatment of chronic intractable migraine is no longer an approved use for these devices.
Insulin infusion sets - multiple brands: The TGA published safety advisories regarding the potential for tubing disconnection due to a manufacturing fault.
Autogen DR Implantable Cardioverter Defibrillator and Autogen Cardiac Resynchronisation Therapy Defibrillator: Boston Scientific issued a hazard alert due to a potential temporarily malfunction if one type of automated test mode is enabled.
3f Enable Aortic Bioprosthesis (model 6000): Medtronic Australasia issued a hazard alert and undertook a recall for product correction due to the potential for valve migration.
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 Office of Product Review 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 Office of Product Review at email@example.com or 1800 809 361.
Medical Devices Safety Update is written by staff from the Office of Product Review.
Editor: Dr Katherine Gray
Deputy Editor: Mr Aaron Hall
TGA Principal Medical Adviser: Dr Tony Hobbs
Contributors include: Ms Jan Law, Mr Patrick O'Meley
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