Medical device regulation – what FDA does when it …：医疗器械监管–FDA所做时候…

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Objectives of the Infant Security Task Force
• Reduce the probability of incidents resulting in harm to or abduction of an infant from the hospital.
• Identify and analyze vulnerabilities and implement reasonably appropriate safeguards to reduce the number of reportable incidents.
• Understand the unique role each business has in the overall effort. Bring together the subject matter experts to dissect issues and look at trends
• Make recommendations to the Security
• Scenario was an infant abduction with shooting of a nurse by an estranged FOB.
• Conflicting response teams:
– Condition C rapid response team – Bronze alert (active shooter response) – Infant Abduction Response
law enforcement command • Engage media relations immediately • Keep in mind multiple events may be occurring (i.e.
Bronze Alert)
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Quality – Routine Checks
• Infant abduction drills are completed quarterly • Infant security task force meets prior to drill
– Discuss past scenarios – Areas of weakness – Test “new” features/upgrades – Test new departments response – Work off past incidents – Review past drill scenarios – Doors stayed open/mom and infant off the unit – Test staff involvement/response and capability of
• Standardize the test to reduce errors • Test tags against one door/exit, rotate exits • Test all components of the system monthly
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Infant Abduction Drills
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Response Plan
• Ensure all staff know their roles/assignments – Create a response matrix
• Law Enforcement notification process • Activate the command center and interface with
• Is most likely compulsive; most often relies on manipulation, lying, and deception. The police characterized abductor as a ‘pathological liar’ and scam artist with an ability to con just about anybody.
Information Systems- Responsible for software/hardware, continuity of operations and servers
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Infant Security Plan
Components of the Plan:
• Identification • Patient Visitation • Infant/Mother Control • Infant Safety Acknowledgement Statement • Access Control and Security Devices • Education • Infant Security System Alarm Response Procedure • Abduction Response Plan • System Outage Procedures
Clinical- Responsible for processes tied to infant protection • Identification • Admit/Discharge • Patient Instructions
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Structure & Membership
Facilities- Responsible for physical assets integrated into the infant program • Doors • Locks • Warning devices/Alarms • Elevators
• Weekly test of a calibrated tag and random sampling – minimum of 5 tags or 10% of inventory
• Two trained staff members are needed with the ability to communicate with each other
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Education and Preparedness
• May 2012 held an Infant Security Summit for UPMC hospitals
• FBI presented on infant abductions • Identified the profile of an abductor • Reviewed all Infant Security plans and tried to
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Sentinel Event: Infant Abduction
Infant Security Task Force - Purpose
Through partnerships, the Infant Security Task Force is dedicated to providing a safe and secure environment that protects our infants, builds trust and enhances the quality of the infant protection program. The task force works both formally and informally to identify issues and concerns and to collectively problem solve.
system – Test downtime procedures
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Education and Preparedness
• February 2012 conducted a table top drill:
– FBI – Local police – Internal media – Multidisciplinary team of hospital staff and providers
the role of the hospital staff • Gained an understanding of communication issues • Understanding of how to manage multiple events
and response plans
Lessons learned…..this could really happen!
Magee-Womens Hospital of UPMC
July 17, 2013 3:00 pm ET
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Sentinel Event: Infant Abduction
Objectives:
• Describe the preparedness training and precautions for infant security
Leadership for Sentinel Events: Infant Abduction at Magee-Womens Hospital of
UPMC
Leslie C. Davis President
Maribeth McLaughlin, RN, BSN, MPM Chief Nursing Officer & Vice President, Patient Care Services
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Education and Preparedness
Purpose of the Drill • Built relationships with local law enforcement and
FBI • Understanding of the role of law enforcement and
identify best practices • Installation of more cameras across the facility