Medical Devices Safety Update, Volume 2, Number 1, January 2014
Medical Devices Safety Update is the medical device safety bulletin of the Therapeutic Goods Administration (TGA)
In this issue
- Alarm problems a top health technology hazard
- Strategies for preventing intravenous and epidural misconnections
- Speedstitch suturing device
Problems with clinical alarms, robotic surgery risks, and radiation exposure in hybrid operating rooms are listed among the leading hazards associated with health technologies.
Between 1 January 2010 and mid-December 2013 the TGA received about 30 reports of adverse events involving device alarms, including at least one patient death.
An international, independent, non-profit organisation researching the best approaches to improving patient care, the Emergency Care Research Institute (ECRI), has again listed problems with clinical alarms as the number one health technology hazard for 2014, citing their prevalence and potential to result in serious patient harm as key factors.1
This is the seventh year of the ECRI Institute publishing its top 10 health technology hazards list. Alarm hazards also topped the list in 2012 and 2013 and ranked highly before that.
ECRI Institute's top 10 health technology hazards for 2014 are:
- Alarm hazards
- Infusion pump medication errors
- CT radiation exposure in paediatric patients
- Data integrity failures in electronic health records and other health IT systems
- Occupational radiation hazards in hybrid operating rooms
- Inadequate reprocessing of endoscopes and surgical instruments
- Neglecting change management for networked devices and systems
- Risks to paediatric patients from 'adult' technologies
- Robotic surgery complications due to insufficient training
- Retained devices and unretrieved fragments.
New hazards in the ECRI Institute's top 10 relate to radiation exposure in hybrid operating rooms and complications arising from insufficient training in the application of robotic surgery. The list also includes two hazards describing risks to paediatric patients: computed tomography radiation dose and the use of technologies designed for adults.
Health professionals are advised to consider ways to mitigate risks within the clinical settings in which they work. An upcoming issue of MDSU will focus on alarm hazards and the work being undertaken to mitigate these risks.
- Top 10 Health technology Hazards for 2014, Health Devices, volume 42, issue 11, November 2013. Emergency Care Research Institute.
Health professionals are reminded of the risks associated with intravenous and epidural misconnections and are advised to take extra care when using infusion ports and connectors.
The TGA has investigated a number of cases involving misconnections, including some reported to it by State and Territory health departments.
Many of these cases resulted in serious adverse events and in some instances were fatal.
In one reported case, confusion between lines resulted in a medicine intended for epidural infusion being inadvertently connected to a catheter for intravenous administration. This error was identified quickly and corrected, so the patient suffered minimal harm and discomfort.
Had the error not been identified early or the situation had been reversed (if an intravenous infusion had been connected to an epidural port), the consequences could have been more serious.
The TGA found that user error was a major contributing factor in many cases.
Additionally, several reports identified Luer locks or adaptors as components that were at higher risk of being involved in misconnections.
A set of seven international standards is being developed to reduce the risk of misconnections in a variety of health care settings and is expected to be completed in 2013-14.
In the meantime, the TGA has reviewed existing literature on preventing misconnections1,2 and is providing the following safety information to assist health professionals with this issue.
- Ensure adequate training of all staff members who are responsible for patient lines and connectors. Ensure this training includes misconnection prevention.
- Ensure staff members are aware that they must trace all lines from the device or solution back to the access point to ensure the correct fluid is being delivered via the correct route.
- When transporting a patient with multiple lines, ensure that handover includes a description of what each line/device is for and where they connect.
- Only use adaptors when they are needed.
- Follow the current National Recommendations for User-applied Labelling of Injectable Medicines, Fluids and Lines, published by the Australian Commission on Safety and Quality in Health Care.
- Develop polices/procedures aimed at preventing misconnection of lines and strategies to deal with the issue should it occur.
- Advise patients to seek help immediately if they become aware of a disconnection and not to attempt to reconnect the lines themselves.
- Report all misconnections.
The TGA is concerned that incidents involving misconnections may be under-reported and reminds health professionals of the importance of reporting all adverse events or near misses involving medical devices.
Reporting adverse events assists the TGA in effectively identifying and responding to safety issues.
Reports can be made via the TGA website.
- Health Devices (2006) Preventing Misconnections of Lines and Cables, ECRI, Health Devices March 2006, Volume 35, Number 3, pages 81 - 94.
- Patton, Kurt A. (2007) A Standards- Based Approach to Preventing Tubing Misconnections, http://www.pppmag.com/documents/V4N10/p16_17_18_20..., Pharmacy Purchasing & Products, October 2007.
Surgeons and sterilisation staff are reminded of the importance of following the manufacturer's Instructions for Use (IFU) when cleaning Speedstitch suturing devices.
The TGA's Incident Report Investigation Scheme (IRIS) has received several reports relating to problems with the needles of Speedstitch suturing devices not working correctly.
Speedstitch is a reusable device that, along with a proprietary suture cartridge and needle package, can be used to suture soft tissue in endoscopic and other limited access procedures.
A manufacturer's analysis of one faulty Speedstitch device identified that a piece of a needle remover was found behind the hook of the needle pushrod. It was determined that this piece had been left behind from a previous procedure, indicating inadequate cleaning of the device had occurred.
The IFU cautions users that immediately after each procedure and before sterilisation, the device should be manually cleaned and scrubbed to remove any visible debris.
If there is visible deterioration, such as damage resulting from wear and tear, the instrument should be retired.
The IFU further stipulates that if the device does not function properly and smoothly to immediately discontinue its use.
The IFU also advises to always have a back-up device available to avoid any delay in surgery in case of a system failure.
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
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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 Ms Sharon Bennett