©ECRIInstitute.Montagnolo.2014 The Supply Chain and Patient Safety Connection... How Will This Relationship Affect Your Patients? April 17, 2014 Anthony J. Montagnolo COO ext

©ECRIInstitute.Montagnolo True or False?

33 Do Beds Kill? ©ECRIInstitute.Montagnolo.2014

Outline  Background--Why are we here?  Medical Products in the Real World ― What 40 years of investigations and testing have taught us  Supply Chain, Patient Safety, Outcomes ― What is the connection?  Action Steps 4

©ECRIInstitute.Montagnolo  Medical errors are a serious problem  The cause is bad systems  We need to redesign our systems  We need to make safety a national priority

©ECRIInstitute.Montagnolo Notice the word “misuse” not just “malfunction.”

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Outline  Background--Why are we here?  Medical Products in the Real World ― What 40 years of investigations and testing have taught us  Supply Chain, Patient Safety, Outcomes ― What is the connection?  Action Steps 9

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11 Near Miss Case Study Look-alike packaging ► Confusingly similar packaging for insulin and tuberculin syringes ► Tenfold overdose of insulin

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ECRI’s Top Ten Health Technology Hazards 1.Alarm Hazards 2.Infusion Pump Medication Errors 3.CT Radiation Exposures in Pediatric Patients 4.Data Integrity Failures in EHRs 5.Occupational Radiation Hazards in Hybrid ORs 13

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©ECRIInstitute.Montagnolo.2014 ECRI’s Top Ten Health Technology Hazards 6.Inadequate Reprocessing of Endoscopes and Surgical Instruments 7.Change Management for Networked Devices 8.Risks to Pediatric Patients from Adult technologies 9.Robotic Surgery Complications 10.Unwanted Retained Surgical items 15

©ECRIInstitute.Montagnolo.2014 Medical Product Safety: What we have learned to watch out for: I.Device Interfaces II.Poor Device Performance III.Hazards from Energy Sources IV.Toxic Materials and Infection Control 16

©ECRIInstitute.Montagnolo I. Device Interfaces Are Everywhere Environment Hospital / Home Patient Device User Accessories/Disposables Breathing Circuits Heated Humidifier Exhalation Filter Electric Power Medical Gas Heat, Humidity, Light Ventilator

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©ECRIInstitute.Montagnolo.2014 II. Poor Device Performance  Avoiding User Error  Selecting Appropriate Technology  Properly Maintaining Technology  Effectively Managing Hazards and Recalls 21

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©ECRIInstitute.Montagnolo.2014 Fact: 50-70% of incidents we investigate are considered user error.  Inadequate pre-use inspection  Labeling errors  Mis-assembly  Improper (“bad”) connection  Incorrect clinical use  Incorrect control settings  Incorrect programming  Spills  Abuse  Inappropriate reliance on automated features  Failure to monitor  Ineffective maintenance or incoming inspection 23

©ECRIInstitute.Montagnolo.2014  Medical device manufacturers circulate approximately 1190 recalls per year  However, not all hazards become recalls!  Hazards may apply to a class of technology not simply a specific brand. 24 Fact

©ECRIInstitute.Montagnolo.2014 Ensure you understand the hazard or recall…  “The calibrations on the reamers may lead to inaccurate reaming depth when used…” (Zimmer, Inc., September 30, 2005)  “Uncommanded motion of the urological table is possible…” (GE OEC Medical, May 12, 2003)  “Slides may exhibit random, elevated imprecision of results” (Ortho-Clinical Diagnostics, March 26, 2003) 25

©ECRIInstitute.Montagnolo.2014 Confusing Recall Notices  “…software might generate an extra result by duplicating the result from the previous sample and the Sample ID/Injection # from the next sample…” A21815 Bio-Rad (February 27, 2014) 26

©ECRIInstitute.Montagnolo.2014 Some are really vague  “Potential risk of guidewire fracture due to handling and operational context” (RADI Medical Systems, May 26, 2003)  “St Jude Medical Inc announced today that it has discovered that background levels of atmospheric ionizing cosmic radiation, more commonly known as cosmic rays, can affect a limited number of …” (St. Jude Medical, October 28, 2005) 27

28 Do Beds Kill? ©ECRIInstitute.Montagnolo.2014

29 Between January 1, 1985 and January 1, 2013, FDA received 901 incidents of patients caught, trapped, entangled, or strangled in hospitals beds. The reports included 531 deaths… ©ECRIInstitute.Montagnolo.2014

30 MonitorRATING Draeger Medical Infinity Patient Monitoring GE Healthcare Patient Monitoring Mindray North America DPM Patient Monitoring Mindray North America Panorama Patient Monitoring Nihon Kohden America Enterprise Monitoring Philips Healthcare IntelliVue Spacelabs Healthcare Monitors Welch Allyn Acuity ECRI Institute Physiologic Monitoring Ratings ©ECRIInstitute.Montagnolo.2014

III. Hazards from Energy Sources  Tissue Injuries  Fire and Explosion  Interference with Other Equipment 31

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©ECRIInstitute.Montagnolo.2014 Common Energy Sources  Surgical Tools Electrosurgical Units (ESUs) Lasers High-speed drills and saws  Imaging Equipment Ionizing Radiation Ultrasound MRI 33

©ECRIInstitute.Montagnolo August 18-25, 2003 ©ECRIInstitute.Montagnolo.2014

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©ECRIInstitute.Montagnolo Fires in the airway can be deadly.

©ECRIInstitute.Montagnolo.2014 So can an alcohol fire on the patient. 37

©ECRIInstitute.Montagnolo.2014 A dose of reality…  In U.S., CT scans estimated to cause 6,000 cancers each year; Avoid unnecessary use Ensure active quality assurance tests Use proper imaging protocols 38

©ECRIInstitute.Montagnolo.2014 IV. Infection Control and Toxic Materials  Cross Contamination  Hazardous Materials  Sharps Safety  Allergy 39

©ECRIInstitute.Montagnolo.2014 When bad things happen at good hospitals… 40

©ECRIInstitute.Montagnolo.2014 Olympus Bronchoscope  Faulty biopsy channel port design allows microorganism entrapment  Numerous patient exposed to problem because hospital didn’t learn about recall in timely manner (Recall was sent to wrong dept) 41

©ECRIInstitute.Montagnolo.2014 The Johns Hopkins Experience  Two patients may have died  Several hundred patients were exposed to potentially contaminated bronchoscopes  Hundreds of patients were contacted for evaluation and offered testing for possible infections 42

©ECRIInstitute.Montagnolo.2014 Outline  Background--Why are we here?  Medical Products in the Real World ― What 40 years of investigations and testing have taught us  Supply Chain, Patient Safety, Outcomes ― What is the connection?  Action Steps 43

©ECRIInstitute.Montagnolo Supply Chain, Patient Safety, Outcomes What is the connection? The patient lives!

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How might Supply Chain help?  Support “Culture of Safety” mindset among staff  Product safety must be part of supply chain goals and incentives  Support use of “systems thinking” to reduce risk 46

©ECRIInstitute.Montagnolo.2014 Checklist for Product Safety Pay close attention to appropriate technology selection and use Ensure patient safety is reviewed before new technology is approved Establish safety-related device selection criteria E.g., sensible alarm parameters, reasonable dose control, etc. Plan for user training during technology acquisitions 47

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©ECRIInstitute.Montagnolo.2014 Checklist For Product Safety Conduct regular ongoing training and check for proficiency of staff using critical high risk devices New staff using existing technology Don’t repeat the mistakes of others Pay close attention to dissemination of hazard data and recall notices 49

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Thank You (And let’s be careful out there.) 51