Medical Devices Safety Update Volume 5, Number 5, September 2017

4 September 2017

Medical Devices Safety Update is the medical device safety bulletin of the Therapeutic Goods Administration (TGA)

Requirements when supplying medical device accessories and consumables

The TGA has noted a rising number of instances of medical device accessories which are being supplied without an appropriate entry in the Australian Register of Therapeutic Goods.

Medical device sponsors are reminded that it is a requirement under the Therapeutic Goods Act 1989 (the Act) to have at all times a current and appropriate entry on the Australian Registry of Therapeutic Goods (ARTG) in order to legally supply a medical device.

Accessories to a medical device, and consumable parts of a medical device system, require their own ARTG entry if they will be supplied on their own.

What is an accessory?

Under section 3 of the Act, an accessory is defined as 'a thing that the manufacturer of the thing specifically intended to be used together with the device to enable the device to be used as the manufacturer of the device intended'. Accessories to medical devices are defined as medical devices under section 41BD(2) of the Act, and thus are required to have an appropriate and current ARTG entry in accordance with section 9A of the Act.

Accessories are designed specifically for a device, and may include consumables, parts, add-ons, and other components for use in conjunction with, or for upgrade, replacement and repair of parts of a medical device. Examples of common accessories may include rechargeable and non-rechargeable batteries that are proprietary in design; filters and cartridges for air, gas and fluid ports; specified disinfectants and cleaning agents; electrical leads/ connectors/ defibrillation pads and even software packages, apps and programs for use with medical devices.

Penalties for not complying

The TGA has noted a rising number of instances of medical device accessories which are being supplied without an appropriate entry. Sponsors are reminded that under section 41MI of the Act, a person who imports, exports, supplies or manufactures medical devices and accessories without inclusion on the ARTG commits an offence, for which imprisonment and/or fines may be imposed as a penalty.

The TGA undertakes post-market surveillance for instances of breaches and illegal supply.

Registering device accessories

Sponsors are urged to review current legislation and legislative requirements along with TGA guidance documents to ensure all devices are correctly included in ARTG and that they continue to comply with conditions of inclusion.

If you have questions device inclusion contact devices@tga.gov.au or 1800 141 144.

Attention to device design can play an important role in minimising user errors

The TGA's investigations have found that poorly designed devices can often enable and induce user errors, and worsen the consequences associated with user errors.

The TGA has received a variety of adverse event reports regarding the wrong information or incorrect rates being entered into devices such as dialysis machines, infusion pumps and insulin pumps.

In all of these cases it is the user’s responsibility to ensure the information entered is correct and to review this before hitting the confirmation button. Users need to be familiar with the Instructions for Use (IFU) and follow them when entering rates into the machines.

However, since user error can never be totally prevented and can be exacerbated by device design, the Essential Principles contained within Australia's medical device regulations place a responsibility on manufacturers to mitigate risks.

Manufacturers must select appropriate solutions for the design and construction of medical devices to minimise any risks associated with their use, including foreseeable misuse.

The Essential Principles also require that the measurement, monitoring and display scale of devices must be designed and produced in accordance with ergonomic principles, having regard to the intended purpose of the device.

While manufacturers are responsible for selecting appropriate design and construction solutions to ensure the quality and safety of their devices in relation to their intended use, the health facilities using these devices also have obligations to ensure effective device management programs are in place.

It is important that the responsible organisations configure their device systems so that operators are not able to compromise them.

Systems issues cannot be solved by any single stakeholder group alone and in working towards effective solutions the TGA believes the following tips can be helpful to reduce user error-related adverse events:

  • Health facilities should:
    • set up effective device 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 IFU.
  • Manufacturers should:
    • 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 IFU is clearly written and that user education is appropriately designed and effectively conducted.

Communication and training vital

Both health facilities and manufacturers have the responsibility to establish effective communication systems to reduce adverse events.

With effective communication and proper user training, users can become familiar with device functionalities and can confidently and competently apply these functions to meet their purposes.

Key points

Medical device users should:

  • follow the IFU
  • double-check inputs into devices before hitting the confirm/start buttons
  • recheck inputs before walking away from the patient
  • identify and remedy any issues before hitting a "reset" button
  • ensure a device is put back together correctly if it has been dismantled or opened, adhering to the IFU
  • if an adverse event occurs that seems to be caused by following the IFU or device prompts, please report it to the sponsor and/or the TGA.

Zimmer safety alert reminds surgeons 'once ceramic, always ceramic'

A safety alert has reminded orthopaedic surgeons not to replace broken ceramic hip components with metal during revision surgery.

Zimmer has contacted Australia surgeons with the reminder following an article in The Lancet[1] which reported severe adverse effects following revision of a Zimmer ceramic-on-ceramic hip implant to ceramic-on-metal due to femoral head breakage.

The purpose of the alert was to provide a reminder about the appropriate hip products/systems to be used after breakage of a ceramic hip component:

Ceramic hip systems have been used in total hip arthroplasty for many years. However, in some cases and due to various factors, revision surgery may be required due to ceramic component breakage.

In these cases of revision, all the ceramic particles must be removed and the wound thoroughly irrigated. The broken ceramic component should be replaced with another ceramic component, resulting in a 'ceramic on ceramic' or 'ceramic on polyethylene' articulation, according to the basic rule 'once ceramic, always ceramic.'

Risks

Because of the risk of ceramic particles remaining in the tissue, the alert advised that use of metal heads for revision after breakage of ceramic components was not appropriate. The potential consequences were:

  • pain, joint effusion, progressive or sudden decrease of mobility
  • foreign body reaction due to ceramic debris/ particles
  • necrosis, pseudo-tumour and aseptic loosening
  • revision surgery
  • premature tribological wear of the revision component due to abrasion caused by remaining particles of the revised ceramic components.

A limited number of case reports in medical literature had suggested potential for systemic cobalt toxicity leading to severe complications, such as death.


References

  1. Dahms et al, 'Cobalt intoxication diagnosed with the help of Dr. House', JR; The Lancet Volume 383, Issue 9916, Feb 2014

TGA encourages reporting of incidents involving the use of surgical staplers

The TGA encourages health professionals to submit adverse event reports relating to the use of surgical staplers.

The TGA regularly receives Device Incident Reports relating to the use of surgical staplers. The problems reported include: misfiring; failure to fire; device jamming; unusual sounds when firing; and staples not forming properly. These events can lead to adverse outcomes including patient bleeding/haemorrhage, leaking of anastomosed staple line, and added operating theatre time.

Some recent examples

In one procedure, a laparoscopic sigmoid colectomy was being performed using a powered vascular stapler.

During the operation, the inferior mesenteric artery was ligated using the stapler and an initial bleed from the distal end of the staple line occurred; this was controlled with suture ligation.

In post-operative recovery on the same day, there was difficulty in raising the patient's blood pressure and the systolic blood pressure would not raise above 80. The patient was returned to theatre and found to be bleeding (pulsatile) from the proximal portion of the staple line. The surgeon had to proceed with an open operation to control the bleeding into the abdomen.

During a laparoscopic low anterior resection procedure:

The colorectal anastomosis was performed by an experienced surgical assistant firing a 29 mm circular stapler. During firing an audible crunch was reported to have been felt and heard. Upon inspection of the donuts, a complete circular rim of tissue was obtained.

Prior to colonoscopy being performed to check anastomosis, the surgeon noted faecal material in the pelvis. The operation was converted to an open procedure. On inspection of the anastomosis site, there did not appear to be any staples deployed. The colorectal anastomosis was hand-sewn, resulting in a surgical delay of two hours.

During a laparoscopic vascular procedure:

The vascular reload was locked down on the renal artery. The surgeon tried to fire the activation button on the handle and it would not work. He noticed that the blade had deployed about half a centimetre during the reload. It was at this point that the surgeon decided to convert from laparoscopic to open surgery. He then used clips and clamped onto the superior mesenteric artery. Once the bleeding had subsided he opened the stapler and removed it from the renal artery. He also sutured in that area to stop bleeding.

To mitigate adverse events involving surgical staplers, health professionals are advised to always follow the Instructions for Use. Patient selection should be considered.

If the device malfunctions, users are encouraged to retain the device and packaging and forward them to the sponsor/manufacturer for investigation.

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:

For more information about reporting, visit www.tga.gov.au or contact the TGA's Medical Devices Branch on 1800 809 361.

Disclaimer

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 2017

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 .


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For correspondence or further information about Medical Devices Safety Update, contact the TGA's Medical Devices Branch at iris@tga.gov.au 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 Chief Medical Adviser: Adjunct Professor Tim Greenaway

Contributors include: Ms Sharon Bennett, Dr Kelly Tsang, Mrs Anne Howatt