Incident Data: Filling the Gaps, Identifying the Value, and Prioritizing Needed Information. Pat Baird October 6 th, 2010

Transcription

1 Incident Data: Filling the Gaps, Identifying the Value, and Prioritizing Needed Information Pat Baird October 6 th, 2010

2 Goal: Look for patterns in the public data to know where to dig for additional investigation Goal is not to repackage or assess any single complaint instead, look for commonalities Meet this by: Look at relative (not absolute) numbers Look for contributors to Harm Look for which safety system failed 2

3 Presentation Overview Methodology Literature Review Analysis Results by Device Type Recall Review Results Summary Open Discussion 3

4 Presentation Overview Detailed Methodology Approach Types of Data Collected Problems Encountered Literature Review Analysis Results by Device Type Recall Review Results Summary Open Discussion 4

5 Review Approach Look for broad patterns of harm Use public data sources Literature / Conference Proceedings Manufacturer and User Facility Device Experience (MAUDE) FDA Class I Recall list 5

6 Review Approach Recalls & Lit Literature / Conference Proceedings Examined 10 years of papers regarding the causes of Harm, but not papers of recommended solutions FDA Class I Recall list Examined 5+ years of Class I recalls for infusion devices 6

7 Review Approach MAUDE Manufacturer and User Facility Device Experience (MAUDE) 3 year review: 1/1/ /31/2009 All Product Types in Guidance except Insulin All manufacturers Death & Injury only, excluded malfunctions 7

8 Data Collected Asking the 5Ws + H Who Age Adult, Child What Outcome Death, Injury When Phase Setup, Programming, Running, Handoff, Teardown Where Care Area ICU, L&D, Home Drug Family Vasoactive, TPN, Insulin... Where (contd) Device Type Syringe, Ambulatory, LVP, PCA Device Configuration Single, Multiple channel device How Hazardous Situation Over Infusion, Under Infusion, Free Flow, Interruption Why Cause Failure, Use Error, Amount/Concentration Slip... 8

9 Additional Data Collected Was there a drug library limits warning noted? Was there a 2 nd clinician verification step noted? Was the device evaluated? Was the device s internal log reviewed? 9

10 Sidebar: Measurement System Analysis & MAUDE Reporting There is variation any time you go to measure something. How repeatable and reliable do I need my measurement system to be? Is MAUDE an acceptable measuring tool? What are the alternatives? 10

11 EVENT DESCRIPTION The customer contact reported an adverse event while the device was in use. On an unspecified date and time, the device was programmed to deliver an unspecified pain medication via an intrathecal catheter and the delivery was started. No specific programming parameters were provided. After an unspecified length of time, the nurse found the patient "face down in bed unresponsive" and a code was initiated. The device was removed from clinical service. During testing at the user facility, the customer contact reported the device passed testing. Multiple unsuccessful attempts were made for additional event information. If additional information is obtained, a follow up report will be submitted. 11

12 Complicating Factors MAUDE is a self report system, records might not contain all necessary information Misclassification 15% of reports about PCA devices were found in General Purpose MAUDE only covers device related issues issues with misconnections, pharmacy errors, drug interaction, etc., will not show up 12

13 Presentation Overview Detailed Methodology Literature Review Analysis Results by Device Type Recall Review Results Summary Open Discussion 13

14 Literature Review Challenges Case reports are about specific incidents, not broad categories Conference proceedings often made best practice recommendations but those are solutions for unstated problems. 14

15 Patient Safety Issues With Patient Controlled Analgesia [D Arcy] A hospital s review of 56 PCA related events showed the sources of error as: PCA programming 71% Human factors / wrong meds: 15% Equipment problems 9% Ordering errors 5% 15

16 Patient Safety Issues With Patient Controlled Analgesia [D Arcy] cont d Common programming errors include: Confusion over milligrams and milliliters PCA bolus dose being confused with the basal rate Loading dose programmed as a bolus dose Wrong lockout selected Wrong medication concentration entered 16

17 Parenteral Medication Errors [Santell] Presented at the 2008 ASHP IV Safety Summit. A review of the MEDMARX database for parenteral errors. 126,596 parenteral errors 3,873 harmful parenteral errors 25 fatalities 17

18 P.M.E. Top 10 Locations of Harmful Parenteral Errors Category MEDMARX % Running % Nursing Unit 49% 49% ICU 14% 63% Pharmacy 9% 72% ED 7% 79% Surgical Services 5% 84% Radiology 3% 88% Maternity/LD 2% 90% Oncology 2% 92% Long term care 1% 93% Outpatient Clinics 1% 94% 18

19 P.M.E. Top Therapeutic Categories most often Involved with Harmful Parenteral Errors Category MEDMARX % Running % Insulin 18% 18% Opiod Analgesics 17% 35% Blood Coagulation Modifiers 9% 44% Beta Lactam Antimicrobials 6% 50% Electrolytes/Minerals 4% 54% Anti Infectives(other) 3% 57% Sedatives/Hypnotics/Anxiolytics 3% 61% Autonomic Medications 3% 64% Adrenal Corticosteriods 2% 66% Diuretics 2% 68% 19

20 Parenteral Med Errors Top Errors Category MEDMARX % Running % Improper Dose/quantity 31% 31% Omission 24% 55% Unauthorized/wrong drug 12% 67% 20

21 Adverse Events with Medical Devices in Anesthesia and Intensive Care Unit Patients Recorded in the French Safety Database in [Beydon] Reviewed 4,188 records in French AFSSAPS Database; 138 Severe Events involving infusion devices Nature of Problem % of Severe Events Error in infusion rate 24% Disconnection and migration in vascular bed 13% Significant vessel lesion during insertion 9% Unrecognized leaks with bleeding 7% 21

22 Presentation Overview Detailed Methodology Literature Review Analysis Results by Device Type MAUDE Review Metrics 5 Ws + H for each Device Type Recall Review Results Summary Open Discussion 22

23 Takeaways from MAUDE Review In general: 1. Rarely was there any Who 2. Quality of report varied by device type 3. Death reports had minimal information; Injury reports had much more 4. FRN (General Purpose) devices had the most complete reporting 23

24 3 yr Review Metrics by Device Type Product Type # D & I Reports # Unique D & I # Injuries # D & PD PCA (MEA) Elastomeric (MEB) Enteral (LZH) General Purpose (FRN) 347* Insulin Body Worn (OPP) Insulin (LZG) Not Reviewed Pump Accessory (MRZ) Total

25 PCA MAUDE Data Review Report Date 1/1/ /31/2009 Event Date 1/1/ /31/2009 Product Code = MEA Death & Injury Reports All Manufacturers / All Brands 160 D&I Reports / 128 Events Meet Criteria

26 PCA What happened? Denominator: 128 Adverse Events Death & Possible Death 13% Injury 87% 26

27 PCA When did it happen? Running 4% Global 7% Change 8% Programming Pump 34% Unknown 47% 27

28 PCA How did it happen? Over Infusion 71% Free Flow 5% Other 1% Unknown 23% 28

29 PCA Why did it happen? Other 3% Unknown 42% Use Error 55% 29

30 Why Use Error Detail # Type of Error % 1 Right data, wrong field a. Drug/Dose Slip 32% 5 6 1a b. Volume/Concentration 3% c. Rate / Concentration Slip 4% 2 Decimal Point Error 10% 3 Wrong Unit ( ml vs mg ) 7% 4 Manipulation Bolus 14% 5 Mis programming 23% 6 Other Use Error 7% b 1c 30

31 Swiss Cheese Theory of Organizational Vulnerability [James Reason] Graphics taken from: The Human Factors Analysis and Classification System HFACS The Swiss cheese model of accident causation February 2000 Scott A. Shappell FAA Civil Aeromedical Institute Oklahoma City, OK Douglas A. Wiegmann University of Illinois at Urbana Champaign Institute of Aviation Savoy, IL

32 Why Use Error Detail # Type of Error % 1 Right data, wrong field a. Drug/Dose Slip 32% 5 6 1a b. Volume/Concentration 3% c. Rate / Concentration Slip 4% 2 Decimal Point Error 10% 3 Wrong Unit ( ml vs mg ) 7% 4 Manipulation Bolus 14% 5 Mis programming 23% 6 Other Use Error 7% b 1c 32

33 PCA 3 Yr. Summary What (Outcome) Injury 112 Death 16 When (Phase) Unknown 60 Programming Pump 44 Change 10 Global 19 Infusion Running 5 Where How (Hazardous Situation) Unknown 30 Over infusion 91 Free Flow 6 Other 1 Why (Cause ) Wrong Field Decimal Point Error 7 13 Wrong units selected 5 9 Manipulation Bolus Mis programming Other Use Error

34 PCA Additional Information After the Adverse Event 49 of 128 Device Log Examined (38%) 28 of 128 Devices Evaluated (22%) When Use Error was a Cause.. 5 of 67 were not caught by Second Clinician Verification (7%) 11 of 67 continued despite a Limits Warning (16%) 34

35 Elastomeric MAUDE Data Review Report Date 1/1/ /31/2009 Event Date 1/1/ /31/2009 Product Code = MEB Death & Injury Reports All Manufacturers / All Brands 498 D&I Reports / 189 Events Meet Criteria

36 Elastomeric What happened? Injury 98% Denominator: 189 Adverse Events Death & Possible Death 2% 36

37 Elastomeric When did it happen? Unknown 62% Teardown 14% Infusion Running 14% Global 9% Other 1% 37

38 Elastomeric How did it happen? Bodily Injury 56% Foreign Object 14% Infection 9% Over Infusion 5% Unknown 5% Other 4% Under Infusion 3% Interruption 1% Chemical Exp 1% Allergic Reaction 1% 38

39 Elastomeric Why did it happen? Catheter Damage 14% Joint / Chondrolysis 53% Use Error 2% Leak 2% Other 5% Unknown 24% 39

40 Elastomeric 3 Yr. Summary What (Outcome) Injury 185 Death 4 When (Phase) Unknown 118 Tear Down 27 Infusion Running 26 Global 17 Setup 1 Where How (Hazardous Situation) Bodily Injury 105 Foreign Object 27 Infection 17 Over Infusion 10 Other 30 Why (Cause) Joint / Chondrolysis Catheter Damage Leak

41 Enteral MAUDE Data Review Report Date 1/1/ /31/2009 Event Date 1/1/ /31/2009 Product Code = LZH Death & Injury Reports All Manufacturers / All Brands 58 D&I Reports / 40 Events Meet Criteria

42 Harm when using an Enteral pump? EVENT DESCRIPTION It was reported to [redacted] that a customer had an issue with a feeding pump. The customer reported that the pump was set at 35ml/hr and the feeding bag was full (at 500ml). At 6am the next morning, she found her daughter unresponsive/deceased and the bag completely empty. 42

43 Enteral What happened? Injury 92% Denominator: 40 Adverse Events Death & Possible Death 8% 43

44 Enteral When did it happen? Manage Exceptions 35% Infusion Running 15% Unknown 37% Global 5% Programming Pump 8% 44

45 Enteral How did it happen? Under Infusion 18% Over Infusion 17% Gastric Air Delivery 17% Interruption 22% Other 5% Exposure to Electrical Energy 3% Burn/Fire/Smoke 3% Unknown 17% 45

46 Enteral Why did it happen? Other 10% Use Error 10% Unknown 47% Failed to Alarm 33% 46

47 Enteral 3 Yr. Summary What (Outcome) Injury 37 Death 3 When (Phase) Unknown 15 Manage Exceptions 14 Infusion Running 6 Programming Pump 3 Global 2 Where How (Hazardous Situation) Unknown 7 Interruption 9 Over Infusion 7 Under Infusion 7 Gastric Air Delivery 6 Other 4 Why (Cause) Failed to Alarm Use Error 4 8 Other

48 Enteral Additional Information After the Adverse Events, 9 of 40 devices were evaluated (23%) 12 of 40 events were reported as being on a child (30%) 48

49 General Purpose (FRN) MAUDE Data Review Report Dates 1/1/ /31/2009 Subset Event Dates 1/1/ /31/2009 Subset Product Code = FRN Death & Injury Reports All Manufacturers / All Brands 600 D&I Reports / 347 Reviewed / 238 Events Meet Criteria

50 FRN What happened? Injury 76% Death & Possible Death 24% Denominator: 238 Adverse Events 50

51 FRN When did it happen? Programming 21% Infusion Running 41% Unknown 25% Change 6% Setup 3% Global 1% Deployment 1% Hand off 1% Tear Down 1% 51

52 FRN How did it happen? Under Infusion 4% Over Infusion 50% Interruption 29% Free Flow 12% Delay 1% Exposure to Electrical Energy 1% Unknown 3% 52

53 FRN Why did it happen? Secondary Use Error 3% Use Error 33% Unknown 27% Alarm 3% Failure/ Malfunction 22% Failed to Alarm 5% Physical Damage 6% Other 1% 53

54 Why Use Error Detail Decimal Point Error 30% Misprogramming 53% Wrong Units Selected 7% Drug/Dose Slip 7% Rate/Concentration Slip 3% 54

55 General Purpose 3 Yr. Summary What (Outcome) Injury 181 Death 57 When (Phase) Unknown 60 Infusion Running 98 Programming Pump 50 Change 14 Setup 7 Other 9 How (Hazardous Situation) Unknown 8 Over Infusion 118 Under Infusion 10 Interruption 70 Free Flow 28 Why (Cause) Use Error Secondary Use Error 7 10 Alarm 8 11 Failure / Malfunction Failed to Alarm Physical Damage

56 General Purpose Addt l Information After the Adverse Event 63 of 238 Device Log Examined (26%) 77 of 238 Devices Evaluated (32%) Breakdown of device type LVP 187 Ambulatory 26 Syringe Pump 26 56

57 Presentation Overview Detailed Methodology Literature Review Analysis Results by Device Type Recall Review Results Summary Open Discussion 57

58 Recall Review Timeframe: 1/1/2005 through 9/30/2010 Infusion pumps excluding Insulin Class I Recalls All manufacturers / all brands 12 Recalls / 21 Issues 58

59 Class I Recall Review Issue Count % Failure Leads to Interruption 8 38% Use Related Error 5 24% Failure Leads to Other Hazard 4 19% Fail to Alarm 2 10% False Alarm 1 5% Other 1 5% Total % 59

60 Presentation Overview Detailed Methodology Literature Review Analysis Results by Device Type Recall Review Results Summary Open Discussion 60

61 61

62 Elastomeric Harm per year Joint / Chondrolysis Catheter Damage Leak Use Error

63 PCA Enteral FRN Total Harm per year (42.6) (13.3) (79.3) (135.3) Failure / Malfunction Use: Mis programming Use: Drug / Dose Slip Use: Decimal Point Error Failed to Alarm Physical Damage Use: Manipulation Use: Wrong units Use: Other Alarm Use: Secondary Use: Rate / Conc. Slip Use: Volume / Conc. Slip Total

64 Presentation Overview Detailed Methodology Literature Review Analysis Results by Device Type Recall Review Results Summary Open Discussion 64