Adverse incidents

Medical device manufacturers, importers and user facilities are obliged to report adverse incidents as summarised in Table 12.4. The criteria for what constitutes a... 

Table 12.4 Summa of Medical Device Reporting (MDR) requirements for individual adverse incidents.

Investigations into Adverse Incidents During Clinical Trials of TGN1412 [online]. Available at http //www.mhra.gov.uk/home/groups/comms-po/documents/websiteresources/... 

The Directives also specify the methodology to be adopted in clinical investigations. Adverse incidents occurring in the investigation must be reported to the competent authority. A general requirement in the MDD is ... 

It is known, however, that drugs are readily available in many prisons, and the rate of adverse incidents and the time and effort spent in detecting smuggling of drugs in has been enough to persuade some authorities that at least the basics of treatment should be available. The most routine option has become to provide a detoxification for opiate misusers, with for instance lofexidine or dihydrocodeine, and also benzodiazepines will often be issued if there is a history of abuse of these and it is intended to avoid the possibility of fits with a short withdrawal course. The adverse incidents in custody and prisons have included some deaths in users of crack cocaine, with physical explanations postulated but no very satisfactory treatment for cocaine withdrawal indicated. Prison services have typically been wary of methadone, and in favouring lofexidine use it was encouraging that a randomized double-blind trial carried out by prison specialists found lofexidine to be as effective as methadone in relief of withdrawal symptoms (Howells et al. 2002). 

The accidents described above are dramatic examples of failure of operating discipline. Experience teaches that some similar failure underlies every adverse incident in a chemical plant. 

Ascertain that there have not been pauses in clinical studies between phase 1 and phase 2. The FDA s policies regarding no pauses apply to the usual situation in which research on a drug progresses without serious adverse incidents. This statement does not, however, take precedence over the FDA s responsibility, when necessary, to stop or limit clinical trials for reasons of safety. (Summary phase 1 data along with the necessary chronic toxicity reports should be submitted to support the safety of phase 2 studies when they are initiated.)... 

Toft B. Toft Report. External enquiry into the adverse incident that occurred at Queen s Medical Centre, Nottingham, 4 March, 2001. London Department of Health . 2001. 

MDA SN9617 (1996) Zirconia Ceramic Heads for Modular Total Hip Femoral Components Advice to Users on Resterilization. Medical Device Agency Adverse Incident Center, Department of Health, London, Safety Notice, June 1996. 

At the heart of patient safety in healthcare is the avoidance of medical error, the failure of a planned action to be completed as intended, or use of the wrong plan to achieve an aim [5], Patient safety involves the study of medical error not for legal or punitive purposes but rather to help us understand the factors which contribute to adverse incidents, to enable learning and prevent harm in the future. 

The lack of adverse incident reporting at the start of this journey has meant that evidence of improvements in patient safety is hard to come by but progress to date has largely been slow. There have been some developments in a number of specific areas where focussed risk reduction have been implemented [18, 19]. However a report in 2011 suggested that, voluntary reporting data aside, up to one third of hospital patients still experienced an adverse medical event [20]. 

Table 1.2 Adverse incidents by problem type (Magrabi et al. [58])...

This differentiation becomes particularly important when dealing with an adverse incident which has implications in the broader context of risk. For example, suppose a HIT system fails to correctly manage a schedule of patient appointments. This could have safety implications if, for example, patients failed to attend urgent appointments as a result. Likewise ... 

Reduction in the cost of managing adverse incidents, legal fees and damage claims... 

Many would say that in the last 10 years a cultural revolution has occurred in healthcare delivery. Organisations in many countries are now more aware than ever of the potential for healthcare to cause harm. In response, most healthcare organisations have put in place measures to identify, report and manage adverse incidents and near-misses along with proactive risk control processes. The challenge for managers of these organisations is to extend this cultural awareness into the implementation of... 

The reporting and analysis of adverse incidents and system defects to drive continual improvement... 

The objective of risk management and a safety culture should be a proactive treatment of clinical risk and therefore minimisation of adverse incidents arising from HIT. Nevertheless this should not detract from the notion that one can learn a great deal from analysing incidents or near misses. A patient safety incident is an event or circumstance which could have resulted, or did result, in unnecessary harm to a patient [22]. The ongoing study of incident reports can help identify common types of problems [23] and incident reporting has been cited as one of the major steps in improving the safety of HIT [24]. 

The role of incident reporting systems in HIT is still unclear from a practical perspective. Challenges remain in particular for ascertaining the precise role of technology in its contribution to an adverse incident, i.e. did it cause the event, fail to prevent it or simply remain a passive onlooker. Certainly the safety case should not be a replacement for sound incident reporting. But keeping a careful eye on local and national incident data will influence the hazards derived and the likelihood component of risk estimation. 

The reporting of adverse incidents should not be relied upon as a sole means of identifying and managing potential hazards. However, the real-world performance of systems is important in assessing the effectiveness of controls and the on-going validity of the safety case. 

One of the key challenges is in establishing the baseline one intends to measure success against. Ideally one would want to implement a HIT system in two identical environments, one with and one without the application of an SMS. In practice this is impractical on many different levels. Of course where an SMS is introduced alongside an existing and establish HIT system one has an opportunity to observe any changes on reported adverse incidents. However one must bear in mind that in this case the opportunities for practical risk reduction in a mature... 

Junior staff are often unfairly blamed for adverse incidents. 

Leape, L.L. (1999) Why should we report adverse incidents Journal of Evaluation in Clinical Practice, 5(1), 1-4. ... 

Inadequacy of existing adverse incident reporting and learning systems ... 

A large number of people use wheelchairs to move from one point to another in the United States. In fact, as per the 2000 census between 1.6 and 2.2 million people in the United States rely on wheelchairs to compensate for mobility impairments [23]. Adverse incidents associated with wheelchair use are not uncommon. As per Refs. [23,24], on the average over 36,500 wheelchair-related nonfatal accidents occur annually and approximately 1 wheelchair-related death occurs per week in the United States. The majority of these adverse events are directly or indirectly associated with falls. 

Walsh, K., Antony, J., Improving on Patient Safety and Quality What Are the Challenges and Gaps in Introducing an Integrated Electronic Adverse Incident and Record System within Health Care Industry., International Journal of Health Care Quality Assurance, Vol. 20, No. 2,2007, pp. 107-115. 

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