Medical devices adverse incidents reported to MHRA 2011 to 2013

Transcription

1 Medical devices adverse incidents reported to MHRA 2011 to 2013 This summary of medical device adverse incident data replaces the annual reports that we have previously published. Further changes are planned for both the content and format of future published data. Those changes will reflect substantial redevelopment of our adverse incident handling processes and, in particular, an expanded approach to continuing incident surveillance and trend analysis. The parallel introduction of new adverse incident data management tools will also allow us to publish updated core data more frequently. These data will be accompanied by thematic and trend reports on particular device types and on identified problem areas. Periodic Summary Reports (PSRs) PSR agreements between manufacturers and competent authorities (such as the MHRA) allow the manufacturer to combine in a single report, similar adverse incidents with the same device or device type, where the root cause is already known or where a field safety corrective action (FSCA) has already been implemented. This is much more efficient for both parties as many adverse incidents can be addressed in a single summary document. Contents Figure 1 Numbers of adverse incident reports 2012 to Table 1 Adverse incident reports and periodic summary reports (PSR)... 2 Figure 2 Sources of reports... 3 Table 2 Types of reports received... 4 Figure 3 Online reports as a percentage of reports received from medical device users and from manufacturers... 5 Table 3 Devices involved in adverse incident reports... 6 Table 4 Table 5 Table 6 Reported event type broad level ISO/TS event types for reported adverse incidents... 7 Reported event type detailed level: ISO/TS event types for reported adverse incidents... 8 Event type categories from ISO/TS used on fewer than 100 occasions... 9 Figure 4 Triage decisions and investigation levels Figure 5 Causes of adverse incidents Table 7 Investigation outcomes investigations concluded Table 8 Safety warnings issued and received Figure 6 Time taken for conclusion of investigations April 2014 page 1 of 13

2 Figure 1 Numbers of adverse incident reports 2012 to ,000 12,000 10,000 Number of reports 8,000 6,000 4,000 2,000 0 Year Table 1 Adverse incident reports and periodic summary reports (PSR) Incident reports received 10,984 13,549 13,642 Periodic summary reports submitted to the MHRA Incidents reported within periodic summary reports 10,745 6,502 1,177 Total incidents reported includes periodic summary reports 21,729 20,051 14,819 Medical devices adverse incidents April 2014 page 2 of 13

3 Figure 2 Sources of reports % of reports NHS Other Government Bodies Private Healthcare Organisations Non-Government Organisations Manufacturers Overseas Reporting Organisations Member of Public Medical devices adverse incidents April 2014 page 3 of 13

4 Table 2 Types of reports received Description of reports or action taken Reported as involving a fatality Reported as involving a serious injury (including implant or pacemaker revision) Prompted MHRA led investigations Investigated by manufacturers under MHRA supervision Not requiring immediate MHRA action. Recorded on database for trend monitoring and pattern detection Reports of incidents similar to those already received by the MHRA Reports from secondary sources, duplicating existing reports Reports not relating to medical devices Reports investigated by other organisations and their conclusion made available to the MHRA* Number of reports Number of reports Number of reports % % % 2, % 4, % 4, % 1, % 2, % 1, % 3, % 4, % 4, % 4, % 5, % 4, % % % 1, % % % % % % % % % % * Incidents reported via the Surgical Materials Testing Laboratory in Wales are no longer included in this category. Medical devices adverse incidents April 2014 page 4 of 13

5 Figure 3 Online reports as a percentage of reports received from medical device users and from manufacturers User Manufacturer (MORE) % of reports Year Medical devices adverse incidents April 2014 page 5 of 13

6 Table 3 Devices involved in adverse incident reports The device groupings shown below cover over 95% of the adverse incident reports we receive. Certain device types do not fit into any of these categories, so are not included in this table. The data are not directly comparable with charts produced in previous years. These figures do not include reports submitted within PSRs. Product category Surgical & patient monitoring 1,694 1,918 2,165 Fluid management (vascular) 1,464 1,637 2,061 Orthopaedic implants 608 1,017 1,462 Active implants 950 1,351 1,351 Non-active cardiovascular implants ,121 Assistive technology 1,328 1,033 1,032 In-vitro diagnostic devices ,031 Plastic, cosmetic and reconstructive surgery implants 323 1, Anaesthetic and respiratory Diagnostic imaging & radiotherapy Fluid management (non-vascular) Wound dressings & bandages Closure devices Ophthalmic implants Obstetric, gynaecology and urology implants Decontamination and sterilisation Dental devices Gloves and barrier contraceptives Laboratory equipment Medical devices adverse incidents April 2014 page 6 of 13

7 Table 4 Reported event type broad level ISO/TS event types for reported adverse incidents In April 2011, the MHRA started to use the international standard ISO/TS :2011 Medical devices - Hierarchical coding structure for adverse events - Part 1: Event-type codes to record incident reports in our AITS database. TS specifies requirements for a hierarchical coding structure for describing adverse events relating to medical devices. The codes are intended primarily for use by medical device manufacturers and regulatory authorities to facilitate collecting and exchanging information. Event type - broad Activation or Positioning or Separation [1000] Computer Hardware [1100] Computer Software [1200] Connection or Fitting [1300] Electrical/Electronic [1400] External Conditions [1500] Implantable Device Failure [1600] Incompatibility [1700] Infusion/Flow [1800] Marking or Labelling or Instructions for Use [1900] Material [2000] Mechanical [2100] Non Mechanical [2200] Output Issue [2400] Packaging/Shipping [2500] Protective [2600] Temperature [2700] Unintended Function [2800] Use Error [2900] Medical devices adverse incidents April 2014 page 7 of 13

8 Table 5 Reported event type detailed level: ISO/TS event types for reported adverse incidents The table below shows the terms that were used on 100 or more occasions. Event type - Detailed [2402] Incorrect or Inadequate Result [2007] Material Separation [2102] Detachment of Device or Device Component [2104] Leak [1703] Patient-Device Incompatibility [2002] Crack [1404] Power Source Issue [2107] Unintended Movement [2403] No Device Output [1403] Device Sensing Issue [2905] Use of Device Issue [1601] Migration of Device or Device Component [1802] Improper Flow or Infusion [2005] Material Fragmentation [2105] Mechanical Jam [2003] Degrade [1902] Markings Issue [2401] Energy Output to Patient Tissue Incorrect [2602] Fail-Safe Issue [1201] Application Program Issue [2503] Packaging [2103] Dislodged or Dislocated [2601] Device Alarm System Issue [1001] Difficult to Position [1702] Device-Device Incompatibility [1002] Failure to Activate [2705] Overheat of Device or Device Component [1806] Insufficient Flow or Underinfusion [1901] Instruction for Use Issue [1202] Programming Issue [2502] Delivered as Unsterile Product Medical devices adverse incidents April 2014 page 8 of 13

9 Table 6 Event type categories from ISO/TS used on fewer than 100 occasions Event type [1805] Excessive Flow or Overinfusion [2502] Delivered as Unsterile Product [2705] Overheat of Device or Device Component [2601] Device Alarm System Issue [2803] Misassembled [1804] No Flow [1305] Loose or Intermittent Connection [1801] Deflation Issue [2501] Damage Prior to Use [1003] Failure to Separate [1803] Inflation Issue [2906] Device Inoperable [1302] Disconnection [2006] Material Perforation [2901] Inadequate or Inappropriate Disinfection or Sterilization [1304] Fitting Problem [2504] Item Contaminated during Shipping [1602] Osseo-disintegration Issue [2101] Calibration [2106] Retraction Problem [1101] Hardware Issue [2801] Device displays incorrect message [2204] Optical Issue [2202] Communication or Transmission Level [2802] Failure to adhere or bond [2004] Material Discolored [2802] Failure to adhere or bond [2004] Material Discolored [1004] Premature Activation [2701] Burned Device or Component [1701] Component or Accessory Incompatibility [1504] Loss of Power 15 6 [1405] Spark [1401] Arcing [2902] Inadequate Training 14 7 [2201] Chemical Issue [2706] Smoking [2702] Fire [2903] Maintenance Issue [2205] Telemetry Discrepancy 9 48 [2203] Installation-Related 8 3 Medical devices adverse incidents April 2014 page 9 of 13

10 [1005] Delayed Activation 6 16 [1306] Misconnection 6 6 [1303] Failure to Disconnect 5 6 [2804] Therapy delivered to incorrect body area 5 6 [1501] Environmental Particulates 5 2 [2505] Difficult to Open or Remove Packaging Material 4 3 [2704] Insufficient Cooling 3 5 [1102] Network Issue 3 9 [2703] Flare or Flash 3 2 [2904] Refurbishing Issue 3 0 [1502] Fumes or Vapors 2 9 [1503] Inadequate Storage 1 4 Figure 4 Triage decisions and investigation levels The current adverse incident handling system was implemented on 01 April The graph below illustrates the immediate impact of the new triage arrangements and the consequent incident investigation levels Trending & surveillance Others* Monitored Specialist % of investigations Year * Knowns, echoes, non-mhra investigations and reports not concerning medical devices Medical devices adverse incidents April 2014 page 10 of 13

11 Figure 5 Causes of adverse incidents Our database has multiple categories that we use to record each incident investigation. The first level provides the three options shown below % of concluded investigations Healthcare establishment or user responsibility Manufacturer responsibility No established device or use link First level category of cause Medical devices adverse incidents April 2014 page 11 of 13

12 Table 7 Investigation outcomes investigations concluded When we conclude an investigation, we record the outcomes. These categories are not mutually exclusive: more than one may be selected for each concluded investigation. Outcome Manufacturer improved QA Manufacturing process modified Design modified Labelling / instructions modified Software upgraded / modified Improved maintenance by manufacturer Production ceased Modified packaging Table 8 Safety warnings issued and received Medical Device Alerts (MDAs) are the MHRA s prime means of communicating safety information to medical device users in health and social care. In circumstances where the target audience for such safety information is small (usually 10 or fewer recipients) a Targeted Letter is produced instead of an MDA. Targeted Letters are sent directly to the identified audience rather than being broadcast to the standard, much wider list of MDA recipients. Competent authority (CA) notifications are issued under the Medical Devices Regulations between the competent authorities of the European Union member states. In many cases they are also circulated more widely to member countries of the International Medical Device Regulators Forum (formerly the Global Harmonisation Task Force). Medical Device Alerts Targeted Letters Competent authority notification: sent Competent authority notification: received (from EU) Medical devices adverse incidents April 2014 page 12 of 13

13 Figure 6 Time taken for conclusion of investigations The length of time taken for completion of an investigation will vary according to a number of factors. These include: the complexity of the research and analysis undertaken the range of people that we need to contact the number of devices involved in the incident, and their location testing of the device by the manufacturer or by independent experts police or coroner involvement, or other legal action. The graph below shows the number of weeks taken for conclusion of 50% and 75% of specialist and monitored investigations % 75% Weeks Monitored Specialist Year Medical devices adverse incidents April 2014 page 13 of 13