Medical Devices Safety Update, Volume 5, Number 2, March 2017
Medical Devices Safety Update is the medical device safety bulletin of the Therapeutic Goods Administration (TGA)
In this issue
Documentation vital if recalls not complete
Health facilities may have justifiable reasons for not following advice given by a medical device sponsor during a product recall, but it is important to document the risk assessment leading up to the decision.
The TGA is aware of several examples of health facilities not implementing device updates during recalls for product correction. These include recalls involving ventilators, linear accelerators, radiation treatment planning systems and clinical information systems.
The reasons given for refusing recalls include:
- not wanting to interrupt clinical workflows (for example, updates to linear accelerators may require extended time out of commission for the update and subsequent testing)
- not needing/using the feature that has been fixed (of course, this may overlook cases in which more than one issue is fixed in software updates - and while the 'headline' issue may not be relevant/wanted, other issues may also be addressed that are important)
- no longer using the item (it may be on-site but 'mothballed').
The TGA does not normally pursue sites that refuse to implement a recall. We require sponsors to make 'reasonable' efforts to complete recalls at all affected locations. What is 'reasonable' depends on the circumstances and nature of the recall.
To mitigate risks to patients, the TGA encourages health facilities to make a well-reasoned and documented risk assessment before refusing or delaying a recall action.
The TGA is also encouraging product sponsors to provide more complete disclosure of software updates to identify all issues that are being corrected and give users a more informed choice.
What records should a facility keep?
A facility declining to implement a recall should complete a well-reasoned risk assessment that is endorsed by the appropriate executive within the facility and stored for future reference.
At the very least when dealing with a recall, a facility should keep detailed records of specific outcomes of all affected devices/products:
- for those actually found and updated/returned/destroyed
- for those not found (and therefore not updated/returned/destroyed)
- when ignoring a recall a facility should keep records as to why (for example, product not used).
Please report issues
In one recent case a number of issues with a medical device had been reported in late 2015. The sponsor conducted a recall with supposed corrections to all the issues. Following the recall, some facilities were still encountering similar issues, but none had been reported to TGA. There was no way for TGA to know of the apparent failure of the recall to address the issues.
This case is ongoing and TGA is working with the sponsor and users to help resolve the issues.
The TGA encourages users of medical devices to report any issues encountered.
Practice points: Topical creams as devices
Clinicians may be surprised to learn that some topical creams are classed as medical devices, while others are classed as medicines.
Unlike medicines, topical creams classed as devices will not have a Product Information (PI) document available online, but will instead come with an Instructions for Use (IFU) document. When treating a patient with such products, it is important to consider the IFU in conjunction with clinical information.
According to the Australian medical devices guidance document number 35 'emollient and moisturising preparations, formulated and presented for therapeutic use' are classed as medicines, whereas 'uncompounded emollients, moisturisers presented for therapeutic use' are classed as medical devices. The essential difference is that those topical creams classed as devices achieve their intended action in ways that do not primarily rely on 'pharmacological, immunological or metabolic means'.
Awareness of the IFU can help prevent adverse events such as the following hypothetical example:
A moisturising cream classed as a medical device is applied to an area of skin treated with radiotherapy. The patient subsequently develops a severe skin reaction.
The IFU and clinical practice documents are retrospectively reviewed. The IFU states that the device should not be used on wounds and should only be used after consulting a physician.
Clinical guidelines provide further information: 'do not use perfumes, deodorants, talcum powder, creams or gels in the treatment field (other than ones recommended/prescribed by the clinical oncologist/radiotherapy treatment centre)' and 'any products containing alcohol should be avoided'.,
The cream used in this case contained alcohol. Consideration of the above clinical information as well as the IFU may have prevented this adverse event.
Information from the Society of Radiographers states that 'currently the quality and quantity of studies evaluating topical agents [for radiotherapy treated skin] appears to be insufficient to support or refute any specific product.'
The above example highlights the importance of considering both currently available clinical information and the IFU of the device to be used when making clinical decisions about patient care.
The TGA cannot give clinical advice regarding medicines, health products or treatments and it is up to each patient's treating physician to consider the currently available evidence to determine which treatment is best for their patient.
Finding IFU information
As discussed in an MDSU article in September 2016, an IFU document is part of a medical device and is essential in enhancing the safety of the device.
Many IFU documents are available online and the TGA anticipates that electronic versions of IFU documents will become increasingly common in the future. When searching for IFU documents online, it can be helpful to search for both the device name, and also use the search terms 'Australian version'
If you review an IFU document and feel that safety information could be improved, please report this to the TGA.
- Australian medical devices guidance document number 35; device - medicine boundary products (pdf,157kb). Therapeutic Goods Administration, November 2005.
- Managing Radiotherapy Induced Skin Reactions: A Toolkit for Healthcare Professionals (pdf,2.90Mb). The Princess Royal Radiotherapy Review Team. St James's Institute of Oncology.
- Mendelsohn FA, Divino CM, Reis ED, Kerstein MD. Wound Care After Radiation Therapy. Advances in Skin & Wound Care: 2002: 15:5; 216-224. Available from: http://pt.wkhealth.com/pt/re/lwwgateway/landingpage.htm;jsessionid=Ys3W3qQ993jxhGlrJg1Tdt3pSnym3WClnNRsMyhbNQV2jln01MS4!1080955772!181195628!8091!-1?issn=1527-794&volume=15&issue=5&spage=216
- Radiation Dermatitis. Uptodate. May 27, 2016.
- Skin care advice for patients undergoing radical external beam megavoltage radiotherapy. Society of Radiographers. 2015, Feb 10.
- What the TGA doesn't do. 2 Aug 2012.
New committee takes over from ACSMD
The TGA would like to publicly acknowledge the contributions of the members of its Advisory Committee on the Safety of Medical Devices. Appointments to the committee were concluded at the end of 2016, with a new consolidated advisory committee structure implemented in early 2017.
Across the TGA in 2017, seven new committees have replaced the previous 11 advisory committees, consolidating the premarket and post-market functions of those bodies.
The functions of the Advisory Committee on the Safety of Medical Devices (ACSMD) have been incorporated into the Advisory Committee on Medical Devices. The new committees will provide advice on specific clinical and scientific matters to aid regulatory decision making, in particular on applications for the market approval of new products and safety issues relating to particular products or product groups.
The committee was established in December 2011 by the Therapeutic Goods Regulations 1990.
The ACSMD provided advice to the Minister for Health and the TGA, on issues relating to safety of medical devices, including risk assessment, risk management and performance. The ACSMD evolved from the Medical Device Incident Review Committee (MDIRC).
There were two Chairs during the life of the committee: Professor Guy Maddern and Professor Guy Ludbrook.
The first ACSMD meeting was held in November 2012 and in total there were 14 meetings. Meeting statements for all but the inaugural meeting are available on the TGA website.
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 Principal Medical Adviser: Associate Professor Tim Greenaway
Contributors include: Dr Alison Stubbs, Mr Patrick O'Meley