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Intranet: http://vaww.ncps.med.va.gov/Internet: http://www.patientsafety.gov/October 5, 2010

AAMI/FDA INFUSION DEVICE SUMMIT

Veterans Health Administration’s Experience and Initiatives on IV and PCA Infusion Devices

October 5, 2010 http://www.patientsafety.gov/ Slide 2

NATIONAL CENTER FOR PATIENT SAFETY (NCPS)

NCPS was established in 1999 to lead the VA’s patient safety efforts and to develop and nurture a culture of safety throughout VHA

• Created a non-punitive environment for reporting

• Close call reports went up 900 fold• What you don’t know you can’t fix

DEFINING THE PROBLEM

• Over 750,000 Safety Reports (11 yrs) including RCAs in the database • 12,000 root cause analysis (RCAs)

conducted in the past 11 years• 978 RCAs involve medical

devices • Out of which 129 involve infusion

pumps (IV & PCA)


DEFINING THE PROBLEM

• Of the 129 RCAs that involve infusion pumps• 60 RCAs are on general

purpose infusion pumps• 69 on PCA pumps• Accounts for over 13% of

medical device related RCAsfor just the two pumps


DEFINING THE PROBLEMhttp://www.patientsafety.gov/CogAids/Triage/index.html#page=page-6


DEFINING THE PROBLEMIV & PCA PUMPS


BARRIERS (B)25% Had these barriers and controls been

evaluated for reliability?29% Were there other barriers and controls

for work processes?18% Was the concept of “fault tolerant”

applied in system design?50% Were the relevant barriers and controls

maintained and checked on a routine basis by designated staff?



RULES/POLICIES/PROCEDURES(R)16% Was there an overall management plan

for addressing risk and assigning responsibility for risk?

27% Did management have an audit or quality control system to inform them how key processes related to the adverse event are functioning?

29% Had a previous audit been done for a similar event, were the causes identified, and were effective interventions developed and implemented on a timely basis?



RULES/POLICIES/PROCEDURES(R)6% Were there written up-to-date

policies and procedures that addressed the work processes related to the adverse event or close call?

17% Were these policies/procedures consistent with relevant federal and VHA policies, standards, and regulations?

8% Were the relevant policies and procedures actually used on a day-to-day basis?



ENVIRONMENT/EQUIPMENT (E)14% Was the equipment designed such that

usage mistakes would be unlikely to happen?

40% Was the design specification adhered to?

50% Was the equipment produced to specifications and operated in a manner the design was intended to satisfy?



HUMAN FACTORS-TRAINING (HF-T)

14% Were the results of training monitored over time?

6% Was the training adequate?



HUMAN FACTORS-COMMUNICATIONS (HF-C)

14% Were policies and procedures communicated adequately?

6% Was the correct technical information adequately communicated 24 hours a day to the people who need it?

25% Were there methods of monitoring the adequacy of staff communications?



HUMAN FACTORS COMMUNICATIONS (HF-C)

19% Was the communication of potential risk factors free from obstacles?

75% Was there a manufacturer’s recall/alert/bulletin on file for equipment, medication, or transfusion related elements at the time of the event or close call? Were relevant staff members aware of the recall/alert/bulletin?

ACTIONS IV PUMPS (STRONG)

45 Standardize Process (protocols, clinical guidelines, order sets)

14 New Device - Medical13 New Device13 Standardize - Equipment9 Engineering Control/Change - Device or Interlock9 Standardize - Coordination of Care7 Leadership/Culture Change6 Architecture/Physical Plant Changes5 Engineering Control/Change - Environmental3 New Device - Non-Medical3 Standardization


ACTIONS IV PUMPS (INTERMEDIATE)

34 Redundancy/Double Checks27 Enhanced Information Display17 Enhance Documentation/Communication16 Eliminate or Substitute System/Device16 Staffing/Scheduling/Assignments14 Manuals/Contracts/Personnel Files8 Software/Hardware


ACTIONS IV PUMPS (WEAKER)

70 Training/Education (staff) 69 Analyze69 Policy/Procedure9 Supervision8 CQI (Continuous Quality Improvement)6 Survey/Inspections6 Visual Warning4 Simulation


ACTIONS PCA PUMPS (STRONG)

81 Standardize - Process (protocols, clinical guidelines, order sets)

20 New Device – Medical20 Standardize – Equipment16 Engineering Control/Change - Device or

Interlock15 Simplify15 Standardize - Coordination of Care

9 New Device6 Standardization2 Leadership/Culture Change


ACTIONS PCA PUMPS (INTERMEDIATE)

36 Enhanced Documentation/Communication

36 Software/Hardware27 Staffing/Scheduling/Assignments26 Enhanced Information Display24 Redundancy/Double Checks8 Eliminate or Substitute

System/Device October 5, 2010 http://www.patientsafety.gov/ Slide 17

ACTIONS PCA PUMPS (WEAKER)

125 Training/Education (staff)

89 Policy/Procedure

45 Analyze

17 Supervision

7 Visual Warning

6 Survey/Inspections

4 CQI (Continuous Quality Improvement)

3 Patient and Family Education

2 Simulation


ACTIONS

• Local issues are addressed locally

• Patient safety managers (PSMs) notify NCPS through many channels: phone calls; emails; issue briefs; and also checking box 6 in the SPOT reporting system (safety reports and RCAs) to inform us of a possibility that the vulnerability might exist at other VA facilities

• NCPS Program Managers & Analyst would call our attention also to problems


ACTIONS

• FEDERAL SUPPLY SCHEDULE (FSS)

• INTEGRATED PRODUCT TEAMS (IPTs)


ACTIONS• 11 years since BCMA was deployed in the

VA• VA initiated labeling of all of our

medications with bar codes long before the FDA mandated the drug manufacturers to label their drugs with bar codes

• Our Electronic Medical Records and Computerized Patient Records System now allows for order entry of IV therapy …the IV bags and syringes are bar coded


ACTIONS

• NCPS has issued Patient Safety Alerts and Patient Safety Advisories related to infusion pumps and tubings on all of the major players

• Some originate from the RCA database some from the in-house repair staff and some are from the manufacturers and other alert service organizations

• We have on occasion acquired funding to replace all the pumps of at least two brands


CHALLENGES

• Cannot Sole Source

• Implementing Robust Wireless Infrastructure and Security Issues

• Waiver process (have been granted)

• Collaborating with manufacturers to fully integrate with BCMA


CONCLUSIONS

• Changing the culture in your organization is like an engine that continues to propel safety

• Use a systems approach (where patient is part of the system) to define the problem, identifying the root causes (usually more than one) is the key to solving problems and stress human factors in the environment as well as the device and software

• Opportunities to prevent problems from happening in the first place (using HFMEA) exist at many levels (local healthcare facility, manufacturer of devices, regulators, national and international)


CONCLUSIONS

• Opportunities to prevent problems from happening again (RCAs) exist at many levels (local healthcare facility, manufacturers of devices, regulators, national and international)

• Healthy, candid, discussions with representation from all stakeholders in a transparent, public arena such as this summit is vital and will get the attention it deserves.

• “Reduction and prevention of inadvertent harm to our patients” … our next steps will determine that we can achieve the goal


aami/fda infusion device summit - amazon...

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