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 2013... 2 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 19218-1 event types for reported adverse incidents... 7 Reported event type detailed level: ISO/TS 19218-1 event types for reported adverse incidents... 8 Event type categories from ISO/TS 19218-1 used on fewer than 100 occasions... 9 Figure 4 Triage decisions and investigation levels... 10 Figure 5 Causes of adverse incidents... 11 Table 7 Investigation outcomes investigations concluded... 12 Table 8 Safety warnings issued and received... 12 Figure 6 Time taken for conclusion of investigations... 13 April 2014 page 1 of 13
Figure 1 Numbers of adverse incident reports 2012 to 2013 14,000 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 106 130 141 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 2011-13 April 2014 page 2 of 13
Figure 2 Sources of reports 60 50 40 % of reports 30 20 10 0 NHS Other Government Bodies Private Healthcare Organisations Non-Government Organisations Manufacturers Overseas Reporting Organisations Member of Public Medical devices adverse incidents 2011-13 April 2014 page 3 of 13
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 294 2.7% 303 2.2% 309 2.3% 2,941 26.8% 4,495 33.2% 4,955 36.6% 1,598 14.5% 2,001 14.8% 1,266 9.3% 3,648 33.2% 4,694 34.6% 4,621 34.1% 4,158 37.9% 5,704 42.1% 4,491 33.1% 662 6.0% 625 4.6% 1,007 7.4% 704 6.4% 696 5.1% 863 6.4% 148 1.3% 185 1.4% 168 1.2% 45 0.4% 58 0.4% 120 0.9% * Incidents reported via the Surgical Materials Testing Laboratory in Wales are no longer included in this category. Medical devices adverse incidents 2011-13 April 2014 page 4 of 13
Figure 3 Online reports as a percentage of reports received from medical device users and from manufacturers 100 90 80 70 User Manufacturer (MORE) % of reports 60 50 40 30 20 10 0 Year Medical devices adverse incidents 2011-13 April 2014 page 5 of 13
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 560 905 1,121 Assistive technology 1,328 1,033 1,032 In-vitro diagnostic devices 740 839 1,031 Plastic, cosmetic and reconstructive surgery implants 323 1,509 539 Anaesthetic and respiratory 533 564 533 Diagnostic imaging & radiotherapy 645 464 442 Fluid management (non-vascular) 486 456 380 Wound dressings & bandages 210 190 238 Closure devices 192 220 213 Ophthalmic implants 169 176 200 Obstetric, gynaecology and urology implants 110 202 178 Decontamination and sterilisation 149 114 145 Dental devices 109 94 93 Gloves and barrier contraceptives 81 70 42 Laboratory equipment 25 18 15 Medical devices adverse incidents 2011-13 April 2014 page 6 of 13
Table 4 Reported event type broad level ISO/TS 19218-1 event types for reported adverse incidents In April 2011, the MHRA started to use the international standard ISO/TS 19218-1:2011 Medical devices - Hierarchical coding structure for adverse events - Part 1: Event-type codes to record incident reports in our AITS database. TS19218-1 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 2012 2013 Activation or Positioning or Separation [1000] 434 321 Computer Hardware [1100] 39 51 Computer Software [1200] 307 269 Connection or Fitting [1300] 280 138 Electrical/Electronic [1400] 743 822 External Conditions [1500] 20 15 Implantable Device Failure [1600] 351 585 Incompatibility [1700] 931 795 Infusion/Flow [1800] 629 593 Marking or Labelling or Instructions for Use [1900] 210 281 Material [2000] 2662 2293 Mechanical [2100] 2582 2570 Non Mechanical [2200] 105 147 Output Issue [2400] 1189 1768 Packaging/Shipping [2500] 327 321 Protective [2600] 219 294 Temperature [2700] 149 237 Unintended Function [2800] 188 131 Use Error [2900] 497 448 Medical devices adverse incidents 2011-13 April 2014 page 7 of 13
Table 5 Reported event type detailed level: ISO/TS 19218-1 event types for reported adverse incidents The table below shows the terms that were used on 100 or more occasions. Event type - Detailed 2012 2013 [2402] Incorrect or Inadequate Result 860 1299 [2007] Material Separation 1292 1258 [2102] Detachment of Device or Device Component 946 1074 [2104] Leak 577 797 [1703] Patient-Device Incompatibility 792 766 [2002] Crack 674 661 [1404] Power Source Issue 337 434 [2107] Unintended Movement 267 406 [2403] No Device Output 162 343 [1403] Device Sensing Issue 222 340 [2905] Use of Device Issue 281 330 [1601] Migration of Device or Device Component 176 304 [1802] Improper Flow or Infusion 181 266 [2005] Material Fragmentation 258 262 [2105] Mechanical Jam 142 246 [2003] Degrade 177 219 [1902] Markings Issue 102 199 [2401] Energy Output to Patient Tissue Incorrect 123 192 [2602] Fail-Safe Issue 121 182 [1201] Application Program Issue 160 174 [2503] Packaging 122 173 [2103] Dislodged or Dislocated 170 160 [2601] Device Alarm System Issue 80 158 [1001] Difficult to Position 164 147 [1702] Device-Device Incompatibility 110 137 [1002] Failure to Activate 189 135 [2705] Overheat of Device or Device Component 89 134 [1806] Insufficient Flow or Underinfusion 176 129 [1901] Instruction for Use Issue 108 129 [1202] Programming Issue 140 121 [2502] Delivered as Unsterile Product 90 105 Medical devices adverse incidents 2011-13 April 2014 page 8 of 13
Table 6 Event type categories from ISO/TS 19218-1 used on fewer than 100 occasions Event type 2012 2013 [1805] Excessive Flow or Overinfusion 91 95 [2502] Delivered as Unsterile Product 90 105 [2705] Overheat of Device or Device Component 89 134 [2601] Device Alarm System Issue 80 158 [2803] Misassembled 72 70 [1804] No Flow 70 75 [1305] Loose or Intermittent Connection 68 25 [1801] Deflation Issue 61 46 [2501] Damage Prior to Use 57 31 [1003] Failure to Separate 56 56 [1803] Inflation Issue 52 55 [2906] Device Inoperable 52 66 [1302] Disconnection 48 37 [2006] Material Perforation 48 38 [2901] Inadequate or Inappropriate Disinfection or Sterilization 48 74 [1304] Fitting Problem 46 37 [2504] Item Contaminated during Shipping 43 73 [1602] Osseo-disintegration Issue 38 60 [2101] Calibration 37 32 [2106] Retraction Problem 35 62 [1101] Hardware Issue 35 55 [2801] Device displays incorrect message 35 41 [2204] Optical Issue 34 43 [2202] Communication or Transmission Level 34 57 [2802] Failure to adhere or bond 34 39 [2004] Material Discolored 28 19 [2802] Failure to adhere or bond 34 39 [2004] Material Discolored 28 19 [1004] Premature Activation 26 37 [2701] Burned Device or Component 24 37 [1701] Component or Accessory Incompatibility 22 37 [1504] Loss of Power 15 6 [1405] Spark 14 16 [1401] Arcing 14 14 [2902] Inadequate Training 14 7 [2201] Chemical Issue 14 17 [2706] Smoking 14 44 [2702] Fire 12 47 [2903] Maintenance Issue 11 20 [2205] Telemetry Discrepancy 9 48 [2203] Installation-Related 8 3 Medical devices adverse incidents 2011-13 April 2014 page 9 of 13
[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 2011. The graph below illustrates the immediate impact of the new triage arrangements and the consequent incident investigation levels. 45 40 35 Trending & surveillance Others* Monitored Specialist % of investigations 30 25 20 15 10 5 0 Year * Knowns, echoes, non-mhra investigations and reports not concerning medical devices Medical devices adverse incidents 2011-13 April 2014 page 10 of 13
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. 50 45 40 35 % of concluded investigations 30 25 20 15 10 2011 2012 2013 5 0 Healthcare establishment or user responsibility Manufacturer responsibility No established device or use link First level category of cause Medical devices adverse incidents 2011-13 April 2014 page 11 of 13
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 373 375 540 Manufacturing process modified 325 308 355 Design modified 231 219 234 Labelling / instructions modified 279 199 274 Software upgraded / modified 133 145 256 Improved maintenance by manufacturer 49 40 92 Production ceased 96 26 21 Modified packaging 17 19 24 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 114 84 86 Targeted Letters 20 17 46 Competent authority notification: sent 157 255 239 Competent authority notification: received (from EU) 518 505 703 Medical devices adverse incidents 2011-13 April 2014 page 12 of 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. 50 45 40 35 30 50% 75% Weeks 25 20 15 10 5 0 Monitored Specialist Year Medical devices adverse incidents 2011-13 April 2014 page 13 of 13