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Medical Devices Safety Update, Volume 3, Number 3, May 2015
Medical Devices Safety Update is the medical device safety bulletin of the Therapeutic Goods Administration (TGA)
In this issue
Retain medical devices associated with adverse event reports
Why you should retain medical devices involved in a suspected adverse event and how to manage this process.
In the January 2015 issue of Medical Devices Safety Update, the TGA provided an update on its IRIS inSite program, a pilot project to support reporting of medical device adverse events in hospitals.
As part of the program, health professionals have received information relating to the key messages of 'Recognise' (what is a medical device and what constitutes a medical device adverse event), 'Retain' (keep the device and its packaging until you find out whether the TGA needs to examine it) and 'Report' (how to report and that you don't have to be certain, just suspicious).
All health professionals can benefit from this information. You don't need to be involved in the program to improve the rate and quality of your medical device adverse event reports.
The following article focuses on the 'Retain' aspect of medical device adverse event reporting and explains why it is important and how to manage this process.
Keeping a medical device and any relevant packaging or documentation that has been associated with an adverse event ensures that the TGA has access to as much information as possible to assist in their investigation of an adverse event report.
Of the many incident reports received by the TGA, very few have the device available for further examination, and yet assessment of physical evidence is often critical in helping to gain a full understanding of an incident.
A lack of physical evidence, including the suspect device, packaging and related documents, can mean that any investigation is difficult and consequently may not help determine the root cause or lead to a definite solution or improvement to rectify the problem.
This is why 'Retain' is a crucial element of the 'Recognise, Retain, Report' message.
What to do when you retain a device
The suspected device, and its packaging and related documentation if possible, should be retained so that a more comprehensive investigation can be undertaken. The TGA has technical staff members who can analyse the materials here in our laboratory facilities, or in more specialised facilities if necessary.
When devices are retained:
- if the device breaks/leaks/bends or so on - keep all the pieces and parts.
- if the device has strip charts or other printouts - retain them (redacted for privacy).
- if the problem occurs with a consumable device and there are unused devices - keep at least one good example along with the faulty units.
- if the device has electronic logs - download, save or print and retain.
- if you have photographs - label, annotate and keep.
When an adverse event occurs write down an account of what happened. Do this as early as possible and include as much information as you can. Provide this information as soon as possible to the TGA. The TGA has an online reporting form at Reporting problems.
Please keep the device until the TGA has received your report and indicated whether we need to inspect the device prior to sending it to the manufacturer. If multiple devices break - keep all the faulty units - however, you need to complete only one online report. There is a field which asks you how many times this problem has occurred.
If the TGA requests that you submit the suspected medical device and other materials, you will be provided instructions for transporting those goods free of charge, including details of the TGA's courier service.
We are aware that there are bio-hazard considerations involved in the storage and transportation of some used devices. The TGA has the capacity to receive contaminated material.
If you are sending a contaminated sample:
- Clean the device as much as possible without destroying any evidence that you feel contributed to the adverse event.
- All devices should be double-packaged in plastic bags designed for transporting bio-hazardous objects. The outer package must be clearly labelled with the contents and warnings if the device is contaminated.
- If the device has sharp edges or components, such as suture needles, please pack these items into a sealed plastic container in addition to the plastic bags. A specimen jar is a good example of an appropriate container.
- Print your TGA report and include that with the sample.
- If you have already been given a Device Incident Report (DIR) number, please add this to the outer packaging.
You can have a positive impact
Recognising medical device adverse events, retaining vital evidence as described above and reporting to the TGA will help us to keep consumers and health professionals in Australia safe.
Your support, and that of your broader organisation, is essential in this important undertaking.
TGA laparoscopic morcellator review
The TGA has now completed a review of all Instructions for Use documents for tissue morcellators currently on the Australian Register of Therapeutic Goods.
The Instructions for Use (IFU) of all laparoscopic morcellators registered on the Australian Register of Therapeutic Goods (ARTG) have been updated following a TGA review.
Laparoscopic morcellators are devices used for division and removal of large masses of tissues during minimally invasive surgeries, including procedures to remove uterine fibroids.
Surgeons are advised that a key message reinforced by the IFU changes is the need to maintain an appropriate informed patient consent process when using laparoscopic morcellators.
Those working with laparoscopic power morcellators are advised to familiarise themselves with the updated information regarding risks and note the addition of 'suspected uterine tumour' as a contraindication.
Changes to the IFU
The IFU for all laparoscopic morcellators were reviewed and the TGA has negotiated with device sponsors/manufacturers to ensure that they:
- include comprehensive details of the risks posed by the use of this device
- specify that sponsors are required to ensure all users are appropriately credentialed and trained in the use of the devices
- reinforce the need for surgeons to have an appropriate informed patient consent process
- include 'suspected uterine tumour' as a contraindication.
The TGA's review was undertaken following a safety communication published by the US Food and Drug Administration in April last year which advised against the use of laparoscopic morcellators during certain uterine surgery procedures. The TGA issued a safety advisory regarding the issue on 29 April last year with an update on 4 August 2014.
Practice points - pleural catheters
In an effort to prevent adverse events, Medical Devices Safety Update will from time to time highlight some important clinical practice points to facilitate the safe use of certain devices.
Pleural catheters are used for a range of clinical indications including malignant pleural effusion.
Although the rate of fractured pleural catheters in Australia appears to be low, the TGA advises health professionals to consider some important clinical practice points when using these devices.
The following case example from published literature illustrates a typical issue:
An 81-year-old man with a history of multiple malignancies, including squamous cell carcinoma of the left lung treated with radical radiotherapy two years before and previous colorectal, prostate, and bladder cancers, was referred for management of left-sided pleural effusion.
He had a trapped lung and recurrent exudative cytology-negative effusions requiring frequent thoracenteses for symptomatic relief.
In view of his age and comorbidity, the patient declined further investigations of the effusion and chose an indwelling pleural catheter (IPC) for symptomatic management.
After five weeks, fluid drainage through the IPC ceased, and no fluid reaccumulation was detected radiologically.
An elective removal of the IPC was performed. The catheter was withdrawn from the pleural cavity after dividing the fibrous adhesions around the cuff.
Although no excessive force was used, when the IPC was withdrawn it appeared to have fractured 6 cm proximal to the cuff. The remainder of the catheter remained in situ.
The skin incision was closed, and the patient remains well at follow-up after 10 months.
There were no adverse events, in particular, associated infection or discomfort.1
The following issues should be considered when using a pleural catheter:
- Removal of pleural catheters can be problematic, especially if a catheter has been in place for an extended period of time. Consider the potential for tissue ingrowth, especially if catheter fenestrations may be located outside the pleural cavity following issues with the insertion technique or movement of the catheter in situ.
- When removing pleural catheters, carefully examine the explanted device for signs of damage or fragmentation. This may include measuring the device and ensuring that the tip of the catheter is present on the explanted device.
- Ensure that the device selected is appropriate for the clinical scenario, especially in regards to the length of time that the device will remain in situ. Catheters are designed for short, medium or long-term placement in situ and therefore the selection of the catheter to be used should consider how long it will be implanted and whether the device is suitable for the outcome sought.
- The clinical consequences of a pleural catheter fragment being left in situ are varied and depend on the specific clinical scenario. The risk/benefit ratio of retrieval measures such as thoracoscopy should be carefully considered on an individual basis.
- For catheters that are introduced through a needle, do not pull back on the catheter during the introduction process, as this may result in the needle sheering the catheter plastic.
- If a catheter is found to be fractured during clinical use, do not discard the device. It is recommended that clinicians report the adverse event to the TGA. Please keep the device until the TGA has received your report and indicated whether we need to inspect the device prior to sending it to the device manufacturer for analysis. This can provide important information regarding potential causes of device fracture. Contact details for the device's manufacturer will be on the Instructions for Use.
Please report all device failures or problems to the TGA.
This information will assist us to continue to monitor and manage issues.
For further information about reporting adverse events, visit the 'Report a problem' webpage on the TGA website.
- Fysh, ETH, Wrightson, JM, Lee, YC, et al 2012. Fractured indwelling pleural catheters. Chest, vol 141, 1090-4.
Recent safety alerts
Below are TGA safety alerts relating to medical devices published since the last edition of Medical Devices Safety Update.
Animas 2020 and IR 1200 insulin pumps: Pumps will cease operation on 1 January 2016.
Astral 100 and Astral 150 ventilators: Risks if disconnection alarms are disabled.
ResMed devices that use ASV therapy: Increased risk of death for patients with symptomatic chronic heart failure.
HeartWare Ventricular Assist System: Multiple potential safety issues.
Invacare Platinum Oxygen Concentrator: Risk of fire from a faulty component.
Invacare TDX and Storm series power wheelchairs: Risk of sparking or fire from a damaged or cut wire.
Accu-Chek Spirit Combo and Accu-Chek Spirit insulin pumps: Risk of insulin not being delivered as intended.
Invacare power wheelchairs: Advertisements to contact consumers affected by earlier recall action.
Birmingham Hip Modular Head: Higher than expected revision rate when used in revisions with an uncemented Synergy stem.
Specsavers' Easyvision Umere Daily contact lenses: Incorrect contact lenses were supplied.
Dianeal peritoneal dialysis solution and various irrigation solutions: Risks caused by potential dilution.
LCS Complete RPS Knee System: Higher than expected revision rate when used without patella resurfacing.
Score Knee prosthesis: Higher than expected revision rate when used without patella resurfacing.
Persona Trabecular metal tibial plate: Potential for implant failure due to loosening.
DeltaLox acetabular shells: Hazard alert due to higher than expected revision rates.
Duodenoscopes used in endoscopic retrograde cholangiopancreatography: Risk of transmitting infections between patients in the US.
Genesis II Knee System - non-porous tibial baseplate: Potential for implant failure due to poor fixation.
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
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.
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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: Dr Cate Brogan and Ms Jan Law