Medical Devices Safety Update, Volume 2, Number 5, September 2014
Medical Devices Safety Update is the medical device safety bulletin of the Therapeutic Goods Administration (TGA)
In this issue
- 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
Several incidents involving patients receiving electric shocks during testing of defibrillator units reinforce the need for operators and health facility managers to ensure the Instructions for Use for these devices are adhered to.
The TGA has received three reports since January 2013 of patients receiving electric shocks during defibrillator checks.
None of the patients was seriously hurt, but the potential for injury was high.
The incidents occurred when operators were undertaking routine defibrillator checks that involved electric discharges.
Instead of checking the devices while connected to a 'test load', the operators checked them while still connected to patients.
With a wide range of different defibrillator models being used in Australia, there is a correspondingly wide range of different instructions for testing and potential for confusion.
Depending on the particular device, there may be several different names for the tests to be performed daily or per-shift, with each having a specific set of instructions for performing the test.
The potential risk is greater if patients are connected to defibrillators for longer than clinically necessary, for example if the defibrillators are primarily being used to monitor cardiac function.
Additional disadvantages of using a defibrillator to routinely monitor patients are that they do not allow connection to central monitoring systems and may not incorporate safety mechanisms to prevent unintentional energy discharges from occurring.
Health professionals using defibrillators are advised to:
- ensure all relevant staff are familiar with the Instructions for Use of each model of defibrillator they may be required to use
- implement policies and procedures to reduce the risk of inadvertent electric shocks (e.g. not testing the device while connected to the patient, requiring all testing to be done outside patient rooms)
- provide education and training on the proper operation, operational checks and dangers associated with using or testing defibrillators.
Health professionals using endoscopes and sterilisation staff are reminded of the importance of adequate cleaning and the adoption of robust reprocessing procedures.
Two incidents in March and April this year reported to the TGA have highlighted issues with items being left behind in endoscopes despite multiple instances of cleaning and sterilisation.
In one incident a small metal clip was flushed out of a colonoscope during cleaning, but this type of clip had not been used in the immediately preceding procedure. The type of clip involved had been used with the colonoscope in a procedure five days earlier.
The manufacturer could not conclusively determine the exact cause of the clip being retained in the colonoscope, but said it was likely that the clip was sucked into the device's internal biopsy channel during surgery and became lodged inside. The device's Instructions for Use warn users to avoid aspirating solid matter. The manufacturer could not rule out that the facility performed insufficient reprocessing or did not perform a biopsy channel inspection before or after use.
In the other incident, a 3 cm pancreatic stent was removed from a patient using a duodenoscope, but was noted not to have exited the device. Brushing of the working channel, leak testing and passage through a normal cleaning cycle did not yield the stent, nor did these activities indicate that the stent remained inside. Over the next five days, four patients underwent procedures using this duodenoscope after it was cleaned and sterilised in the usual manner. The stent came out of the scope during the fourth procedure.
To help avoid incidents such as these, health facilities are advised to ensure appropriate education is in place for staff cleaning and sterilising endoscopes.
If items have been retrieved from a patient via the channel of an endoscope, the nurse in charge of the procedure is advised to ensure they are accounted for after removal.
If the item is not retrieved from the scope, it is advised that the person in charge of the procedure notify the person cleaning the scope so that additional inspections are undertaken to rule out the item remaining inside the device.
Inadequate reprocessing of endoscopes and surgical instruments was listed in the Emergency Care Research Institute's top 10 health technology hazards for 2014, as reported in the January edition of MDSU.
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.
Ellipse implantable cardioverter defibrillators: St Jude Medical has issued a hazard alert and is recalling unused stocks and replacing them with redesigned devices.
Laparoscopic power morcellators - update: The TGA has provided updated advice regarding potential safety concerns with these devices.
Codman Certas Programmable Valves: Johnson & Johnson Medical has issued a hazard alert for two Codman Certas Programmable Valve products.
NexGen Complete Knee Solution MIS stemmed tibial component (various sizes): Zimmer has issued a hazard alert due to faulty threads in some devices manufactured before 3 April 2014.
MSA Hip System - femoral hip replacement with modular neck: Global Orthopaedic Technology has issued a hazard alert due to a higher than expected revision rate.
Health professionals and facility managers are reminded of the importance of following the manufacturer's Instructions for Use when using slings to move patients, as well as the need to ensure regular maintenance of slings and associated equipment.
The TGA has received 10 device incident reports in the past two years involving patient slings.
Investigations determined that the majority of these incidents resulted from user error, through not following the Instructions for Use (IFU) or due to the lack of regular maintenance on the devices.
Accidents caused by not following the IFU or lack of maintenance have caused injuries to both patients and carers.
One common cause of incidents has been sling clips detaching from the hanging mechanism.
In many of these cases the clips were not secured according to the IFU. Other causes include broken clips and other broken components. In two of the reports, the patient died after the reported incident.
Health facilities should ensure all staff who operate slings and patient lifters are adequately trained and have read and follow the IFU.
All equipment should be regularly inspected and maintained.
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 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 2014
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 email@example.com.
For the latest information from the TGA, subscribe to the TGA Safety Information email list.
For correspondence or further information about Medical Devices Safety Update, contact the TGA's Office of Product Review at firstname.lastname@example.org 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 Mr Jim Andrews, Ms Sharon Bennett, Mr Shawn Hazel