Rapid Responses to:
|
|
Rapid Responses: Rapid Responses published:
-
![[Read Rapid Response]](/icons/misc/sectionDOWN.gif)
Giving quality the common touch
- Margaret Kuhne (9 August 2002)
-
Under-reporting of adverse events related to medical devices
- Nicola Baker, Claire Tweedale, Chris J. Ellis (14 August 2002)
-
Human capability, a quality definitely worth investing in
- Harri Sievanen (20 August 2002)
-
Risk assessment: an aid to reduce incidents involving medical devices?
- Yapa Wickramasinghe (20 February 2004)
|
|
|||
|
Margaret Kuhne, Community Health Coordinator South Gippsland Hospital Station Road Foster 3960
Send response to journal:
|
Dear Editor, It was pleasing to read of such an enlightened but simple approach to preventable adverse incidents in BMJ 2002/325:272-275 (August 3). For too long the term ‘quality’ has been bandied about by the academics and administrators who seem to want to keep the idea for themselves, and their staff in the dark. Amoore and Ingram (1) are doing their part to make the idea of quality improvement a meaningful one. A ‘quality’ approach needs to be a systems approach if it is to succeed (2). Unfortunately the methods used to convey this message to staff can be too academic and alienate them from the quality process. Those involved in the development of quality programs too often use expressions that are meaningless and irrelevant to those they are hoping to inspire. Staff need tangible outcomes that show the system working and encourage them to participate in the process. The development of feedback notes is an example of such a positive tool. The feedback note promotes a ‘no blame’ system with an educative element (1). Detailing the positive actions taken by staff, as well as the causes and events that led to error is an excellent method of engendering an open reporting culture. It is encouraging to note that the staff are now more forthcoming with information about adverse events in relation to equipment. The final step in the feedback note process, that of sharing the information anonymously throughout the organisation, ensures that as wide a audience as possible can use this experience to learn and improve their practices. The increasing use of medical technology creates an environment with increasing potential for adverse events, despite the best efforts to the contrary (3). Errors when using medical devices arise as a result of a variety of factors from knowledge deficit, poor storage, inappropriate use etc. (1). In the health care industry adverse events can never be totally prevented, but we can work towards risk management and minimising severity by analysing these event sin a non-punitive way. The feedback note approach taken at the Royal Infirmary of Edinburgh is innovative in that the process is a meaningful one for staff. As a component of a quality program, it provides an excellent tool to demonstrate the actual benefits that can be achieved by a commitment to quality, and one that will be instigated within my own organisation. (1) Amoore JN, Ingram P. Learning from adverse incidents involving medical devices. BMJ 2002; 325:272-275 (2) McNeil JJ, Ogden K, Briganti E, Ibrahim JE, Loff B, Majoor JW. Chapter 2: Leterature review. Improving patient safety in Victorian hospitals. Victoria: Department of Human Services, 2000: 14 (3) Kohn CT, Corrigan JM, Donaldson MS. Chapter 8: Creating safety systems I health care organizations. To err is human: building a safer health system. Washington: National Academy Press, 1999: 139 |
|||
|
|
|||
|
Nicola Baker, Specialist Registrar Microbiology Birmingham Heartlands Hospital, Bordesley Green East, Birmingham, B9 5SS, Claire Tweedale, Chris J. Ellis
Send response to journal:
|
Editor - In their article Amoore and Ingram quote figures of 400 people a year seriously injured or killed as a result of adverse incidents involving medical devices (1). We believe that this figure merely represents the tip of the iceberg, and that many more cases occur which are simply not recognised. Infectious complications of medical devices are often not considered in the context of reporting, and so the possible lessons that can minimise recurrence remain unlearnt. One of the most commonly used medical devices in hospitalised patients are peripheral intravenous catheters. In our trust alone, approximately 32% of all in-patients have a peripheral intravenous catheter (PVC) in situ at any one time. The risk of serious complications associated with these devices is generally perceived to be low. However, over the last year we have documented 19 cases of Staphylococcus aureus bacteraemia resulting from infection of PVCs. Data from the Nosocomial Infection National Surveillance Service (NINSS) suggests that at least 7% of all nosocomial bacteraemias are related to PVC use (2). A study of 146 PVCs in our Trust demonstrated a serious complication rate of 5.5% (3), a level much higher than that quoted in other studies where PVCs are inserted by dedicated teams (4). We have performed two studies of PVC insertion and care which have sought to identify those factors responsible for these complications. An observational audit in the emergency areas demonstrated that 63% of healthcare workers made no attempt to decontaminate their hands and 13% failed to clean the skin adequately prior to inserting PVCs. 20% of all PVCs inserted and remaining in situ were not used at all in the next 48 hours. A snapshot survey of PVC care showed that a third of all PVCs were not in use and 9% had never been used since insertion. 60% of all PVC insertion sites were not visible, usually a result of them being obscured by bandages. A number of simple measures have been identified which could reduce the risk of complications occurring as a result of PVC insertion, including the immediate removal of PVCs no longer in use, daily inspection of PVC insertion sites for local complications, and attention to the use of asepsis when inserting PVCs. It is easy to perceive that failure of medical equipment per se requires reporting and action to be taken to prevent adverse consequences. Yet failure of simple good practice measures, leading to serious complications of commonly used devices is not being addressed. The simple scheme described by Amoore and Ingram needs to be extended to encompass a wider range of events, including infectious complications of medical devices, so that these can be highlighted. References 1. Amoore J, Ingram P. Learning from adverse incidents involving medical devices. BMJ 2002; 325: 272-275. 2. Nosocomial Infection National Surveillance Service (NINSS). Surveillance of hospital-acquired bacteraemia in English hospital 1997- 2000. PHLS 2002. 3. Greig J.M., Ellis C.J., Smith E.G. Septic discitis and other complications of peripheral venous cannulation. QJM 2002; 95(6): 412. 4. Maki D.G., Ringer M. Risks of infusion related phlebitis with small peripheral venous catheters. Ann Intern Med 1991; 114: 845-854. Dr Nicola Baker Claire Tweedale Dr C.J. Ellis |
|||
|
|
|||
|
Harri Sievanen, Senior Officer Medical Devices Centre, National Agency for Medicines, FIN-00301, Helsinki; Finland
Send response to journal:
|
EDITOR - Amoore and Ingram highlight one of the most fundamental aspects underpinning the safe use of medical devices, learning from experience so that the same kind of incidents do not recur.1 Globally harmonised regulations require medical devices be designed and manufactured in such a way that their performance and properties remain as intended throughout their whole operation life and that they do not compromise the safety of the patient or any other person. On one hand, there is thus a strong presumption that medical devices are acceptably risk-free and appropriate for their intended purposes, but on the other, absolutely zero-risk devices are never possible. When an incident involving a medical device happens, careful resolution of the course of all related events and actions, probable cause of the incident and its potential link to device properties or performance, as well as a prompt notification to the manufacturer (or his representative) and relevant national authority (irrespective of whether mandatory or not) largely determine what we can really learn from these incidents. Should the incident remain a secret of small circles, virtually nothing useful is learned. The users constitute thus the first and most crucial link in the chain, making their co-operation a true cornerstone of this process.2 Inherent fear of being blamed apparently impedes the users’ willingness to report on incident(s), but the blame can be put on the user only and only if he/she knows: (a) that an error has actually occurred, (b) how to correct the error, and (c) how to prevent the error. If not all of these three conditions are met, the error should be considered a fault of the system.3 While keeping the medical devices in appropriate operating order, health care organisations should also arrange ongoing training programmes on medical devices to their personnel. The training should not only focus on hands-on skills necessary for the use of devices but also on providing adequate understanding of their basic operating principles. This, in conjunction with constructive feedback about performance, e.g., through feedback notes on incidents,1 most likely help the users gain the capability4 needed to cope effectively with uncertain and surprising circumstances that may well arise while using the devices. This has come particularly concrete today as novel medical devices evolve all the time, many different brands and generations of similar devices are being used side by side and possibly made compatible with a variety of adapters, many ageing devices lack adequate safeguards etc.. Under these circumstances, it is the human capability that in the form of compensations and adaptations to changing and potentially hazardous circumstances represents one of the most important safeguards against adverse incidents.5 Harri Sievanen, ScD, Senior Officer
1. Amoore J, Ingram P. Learning from adverse incidents involving medical devices. BMJ 2002;325:272-275. 2. Sievanen H. Review of the EU medical device vigilance system: Finland’s experience in 2001. The Regulatory Affairs Journal (Devices) 2002;10:119- 122. 3. Gambino R. Most laboratory errors are system dependent – not people dependent. Lab Med 1989;20:123. 4. Fraser SW, Greenhalgh T. Coping with complexity: educating for capability. BMJ 2001;323:799-803. 5. Reason J. Human error: models and management. BMJ 2000;320:768-770. |
|||
|
|
|||
|
Yapa Wickramasinghe, Consultant Scientist and Hon Senior Lecturer Department of Clinical Technology, University Hospital of North Staffordshire, NHS Trust, ST4 6QG
Send response to journal:
|
Novel or new medical devices with the CE mark as well as in-house built or modified medical devices have the potential to cause an incident. A risk assessment of such a medical device, before it is used by hospital staff, will enable the identification of potential issues such as: lack of user training and user instructions (1). Amoore and Ingram (2)highlighted the value of learning from experiences. We at the Clinical Technology Department have developed a risk assessment tool (3), based on the BSEN ISO 14971: Medical Devices-Application of risk management to medical devices. This enables one to assess risks associated with any one of the following: 1. Existing medical devices linked to frequent incidents 2. Non-CE marked medical devices that are subjected to a clinical evaluation for the purpose of obtaining a CE mark 3. In-house built or modified (with the approval of the manufacturer) medical devices before they are used with patients. The tool is a series of questions relating to human error, environmental hazards as well as those generated by the device itself, and requires one to first assess the level of risk and then provide how they are eliminated or reduced to an acceptable level. On the issue of quality improvement the actions taken at the Royal Infirmary of Edinburgh is commendable. Learning from best practices such as these together with effective risk assessment would constitute an excellent incident preventive action. Dr. Yapa Wickramasinghe, Consultant Scientist and Hon Senior Lecturer, Department of Clinical Technology, University Hospital of North Staffordshire, Stoke-on-Trent, ST4 6QG (1) Spencer SA, Nicklin SE, Wickramasinghe Y, Nevill A, Ellis SJ. An essential "health check" for all medical devices. Clin Med 2003;3:543-5 (2)Amoore J, Ingram P. Quality improvement report: Learning from adverse incidents involving medical devices. BMJ 2002;325:272-275. (3) Wickramasinghe Y. Risk analysis 2003. www.partnersinpaediatrics.org.uk, see papers and reports/other reports Competing interests: None declared |
|||