1. The Supply Chain and Patient Safety Connection...
How Will This Relationship Affect Your Patients?
CAHPMM 41st Annual Conference
October 2014
Anthony J. Montagnolo
COO
ext. 5175

2. True or False?
Patient blows up on operating table---I hate when that happens!
Stuff like this actually happens. We investigate this stuff all day long. Unfortunately.

3. Do Beds Kill?
©ECRIInstitute.Montagnolo.2014

4. 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
Here’s what we are going to try to cover today. Some basic information and experience on how to choose and use medical devices safely.

5. Institute of Medicine (IOM) Findings
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

6. Notice the word “misuse” not just “malfunction.”

9. 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
Here’s what we are going to try to cover today. Some basic information and experience on how to choose and use medical devices safely.

10. ©ECRIInstitute.Montagnolo.2014

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

12. ©ECRIInstitute.Montagnolo.2014

13. ECRI’s Top Ten Health Technology Hazards
Alarm Hazards
Infusion Pump Medication Errors
CT Radiation Exposures in Pediatric Patients
Data Integrity Failures in EHRs
Occupational Radiation Hazards in Hybrid ORs
Medical Technology Safety is one aspect of the technology assessment process.

15. ECRI’s Top Ten Health Technology Hazards
Inadequate Reprocessing of Endoscopes and Surgical Instruments
Change Management for Networked Devices
Risks to Pediatric Patients from Adult technologies
Robotic Surgery Complications
Unwanted Retained Surgical items
Medical Technology Safety is one aspect of the technology assessment process.

16. Medical Product Safety: What we have learned to watch out for:
Device Interfaces
Poor Device Performance
Hazards from Energy Sources
Toxic Materials and Infection Control
Medical Technology Safety is one aspect of the technology assessment process.

17. 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

20. March 2006

21. II. Poor Device Performance
Avoiding User Error
Selecting Appropriate Technology
Properly Maintaining Technology
Effectively Managing Hazards and Recalls
Selection involves identifying clinical requirements.
Ex: If the Xenon light source is not a requirement, selection of the Halogen light source will save money and reduce risk.
Maintenance is still crucial to the performance of some technologies. Don’t be lulled to sleep by the fact that many technologies, such as infusion pumps and electrosurgical units, require little or no maintenance.
User Error can not be entirely avoided. However, there are technology solutions that substantially reduce risk. ECRI’s recent evaluations of Physiologic Monitoring Systems have found that the logic controlling alarms and alarm suppression is now the most significant distinction among systems.

22. Can you say user error?
Oh, yeah what it does not say is that our staff had been awake for 36 hours!

23. 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

24. Fact
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.

25. 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)

26. 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)
A21852 Abbott {February 2014) “This communication is not being done to reduce risk to health.”
Intended Meaning: This issue will not affect patient health. Rather, they are claiming that the alert is a warning about how data is transferred between point-of-care device and a data storage device and that the issue has no safety implications.
A21815 Bio-Rad (February 27, 2014) “software might generate an extra result by duplicating the result from the previous sample and the Sample ID/Injection # from the next sample”
Intended Meaning: That’s just plain confusing

27. 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)

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. ECRI Institute Physiologic Monitoring Ratings
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
©ECRIInstitute.Montagnolo.2014

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

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

34. August 18-25, 2003 For example: wart removal fire
©ECRIInstitute.Montagnolo.2014

36. Fires in the airway can be deadly.
Tracheostomy fire. Click for burned photo at climax of description.

37. So can an alcohol fire on the patient.
Describe breast biopsy fire

38. 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

39. IV. Infection Control and Toxic Materials
Cross Contamination
Hazardous Materials
Sharps Safety
Allergy
Electronic thermometers
Pros - save a lot of time by comparison to traditional glass thermometers and eliminate the environmental and regulatory issues surrounding mercury.
Cons – Elevated risk of cross contamination among patients. (Referred to as Nosocomial infections)
Chemotherapy clinics require proper hazardous material clean-up and disposal expertise.
Needle-stick injuries have lead to needle-less IV connectors and sharps disposal containers.
Anaphylaxis triggered by latex products has become such a prominent issue…

40. When bad things happen at good hospitals…

41. 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)

42. 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

43. 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
Here’s what we are going to try to cover today. Some basic information and experience on how to choose and use medical devices safely.

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

45. ©ECRIInstitute.Montagnolo.2014

46. 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

47. 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
Wrapping up on slide 11 with the general recommendations.
After available resources, consider talking about having a handle on recall tracking.
After checking for proficiency, consider talking about doing technology safety audits to make sure that you are meeting your hospital’s safety criteria.

49. 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
Wrapping up on slide 11 with the general recommendations.
After available resources, consider talking about having a handle on recall tracking.
After checking for proficiency, consider talking about doing technology safety audits to make sure that you are meeting your hospital’s safety criteria.

50. ©ECRIInstitute.Montagnolo.2014

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