Transcript Medical Product Liability

XIII. Hospital Ethical and
Legal Responsibilities with
Medical Devices
TRAINING SEMINAR ON
MEDICAL DEVICE
ACCIDENT INVESTIGATION
for
Kingdom of Saudi Arabia
Saudi Food & Drug Authority
Riyadh 11-14 February, 2007
Presenter:
Mark E. Bruley
Vice President, Accident and Forensic Investigation
ECRI
5200 Butler Pike, Plymouth Meeting, PA, 19642 USA
Tel: +1 610-825-6000, ext. 5223 E-mail: [email protected]
Web Sites: www.ecri.org
www.mdsr.ecri.org
Laws, Regulations, and Standards
Duty to Select Proper Equipment
Duty to Manage Equipment to
Ensure Safety
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Why Risk Management for
Ethical and Legal Issues?
New Technologies
New Settings
Compliance - National or Local
Directives
Media Attention
Lawsuits
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Who’s responsible when
accidents happen?
Manufacturers
Distributors/Sellers
Hospitals
Servicers
Users - Physicians, Nurses, etc.
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Medical device system
Patient
User
Device
Environment
Accessories
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What went wrong?
What was the injury?
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Duty to Warn/Informed Consent
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Who must warn the provider?
Manufacturer must inform of potential
side effects via an adequate method
(product inserts, “Dear Doctor” letters,
personal contact)
Learned intermediary doctrine
– applies when healthcare provider
selects and is needed for safe,
effective use
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Who must warn the provider?
 No post-sale duty of the manufacturer to warn of
confusion with dual flowmeters if user knows of
defect or safety device.
Olsen v. Ohmeda, 863 F. Supp. 870 (E.D.Wis. 1994)
 Plastic surgeon may sue breast implant
manufacturer for failure to warn under the learned
intermediary doctrine.
Vitolo v. Dow Corning, No. 12624/94 (9/95, Sup. Ct. N.Y. )
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Who must warn the patient?
Provider, not manufacturer.
– Manufacturer had no duty to warn the patient of
“pinch-off” syndrome of catheter associated with
Hickman Subcutaneous Port.
Pumphrey v. Bard, 906 F. Supp. 334 (D.C. W.Va. 1995)
 Exceptions: vaccines, oral contraceptives,
“over the counter” (OTC) drugs
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Informed Consent - Implants
Physician Responsibility
– Must tell patient about selected implant
– Must also tell about available alternatives
The selection of a particular heart valve must be
part of the informed consent process where there
are other available recognized alternatives.
Stover v. Assn. Of Thoracic and Cardiovascular
Surgeons, 635 A.2d 1047 (Pa. Super. 1994)
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Informed Consent Investigational Devices
May trigger a hospital duty to inform.
• Hospital, by participating in FDA clinical
investigation, assumed a duty to obtain the
informed consent of a recipient of an
investigational IOL. Friter v. Iolab, 607 A.2d 1111 (Pa.
Super. 1992); Kus v. Sherman, No.2-94-0156 (Ill.App. 1995)
• Failure to inform patient that Wiltse II spinal
fixation device was experimental may
constitute negligence per se. Daum v. SpineCare
Medical Group, No. Ao68116 (Cal. App. 1997)
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Informed Consent Off-Label Use
U.S. FDA does not regulate physician
practice.
No automatic malpractice.
May trigger hospital informed consent
responsibility.
• Pedicle screw cases: Saylor v. Providence,
680 N.E.2d 193 (Ohio App 1996)inadequate
warning claim; Corrigan v. Methodist, No. 941478 (E.D. Pa. Nov. 1994) informed consent.
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Informed Consent
State statute – Pennsylvania, USA.
– Physician must get informed consent for
inserting surgical device, using an
experimental device, and using a device
in an experimental manner.
U.S. Federal regulations on human
research
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Off-label use
Risk management:
– Scientific studies supporting use
– Availability of approved alternatives
– Widespread use by others
– Informed consent
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Top FDA Device Problems Reports
(Manufacturer and User Device Experience Database)
 Infusion pumps
 Penile prostheses
 Angioplasty
catheters
 Clip applicators
 Ventilators
 Defibrillators
 Suture Units
 Pacemakers and
leads
 Intra-aortic balloon
pumps
 Urethral sphincter
prostheses
 Heart valves
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Hospital Responsibilities
Duty to maintain a safe workplace
Duty to select/provide safe products
Duty to manage and maintain
Duty to use products properly
Duty to educate/credential
Duty to warn of risks
Duty to comply with
statutes/regulations
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Selecting and Providing
Unsterile Equipment
– unsterile instruments permit an emotional
distress claim.
Howard v. Alexandria, 429 S.E.2d 22 (Va. 1993)
No verification of implant
– Hospital checked hip prosthesis against packing
slip, not contents.
Dalton v. Kalispell, 846
P.2d 960 (1993)
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Selecting and Providing
How safe is safe?
– Need not be the newest or most modern; must
be reasonably safe and appropriate.
Milner v. Huntsville, 398 S.W.2d 647 (Tex. 1966)
Risk Management
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Gather safety information before you purchase
Compare brands and models
Evaluate user skills
Health Devices, Health Device Alerts, et al
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Standard of Care
Risk Management
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Professional standards
Statutes and regulations
Manufacturer’s instructions/labeling
Hospital documents
Publications and treatises
Experts
Healthcare Standards Directory (ECRI)
Networking
Literature searches
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Managing and Maintaining
Medical Technology Management
Critical Links with Patient Care
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Technology Assessment
Tendering
Use
Multiple Activities in Many Departments
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Managing and Maintaining
 Self-Assessment Questionnaire
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Planning
Acquisition (Tendering)
Risk Management
Technology Management
Hazards and Recalls
Education and Training
Medical Staff Credentialing and Privileging
Adverse Event Reporting
Equipment Disposal
Infection Control
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Managing and Maintaining
Duty to inspect and maintain
– Hospital has duty to inspect, maintain, and set up
CO2 laser equipment; physician has duty to take
test-fire just before use; physician has duty to
stop procedure once problem arose.
Mahfouz v. Xanar, 646 So.2d 1152 (La. App. 1994)
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Managing and Maintaining
Duty to respond to hazards and recalls
– Failure to check newly purchased device against
past recalls.
Pearce v. Feinstein, 754 F.Supp. 308 (W.D.N.Y. 1990)
Duty to respond to reported problems
– Internal reports
– Assess for SMDA reportability
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Hazards and Recalls
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Hazards and Recalls
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Risk identification - products
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Overdue IPMs
Safety committee reports
Downtime
Repeat repairs
Calls for unneeded repairs
Incident reports
Service contracts
Hazards and recalls
Complaints
Credentialing
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Education and Credentialing
Duty to educate device users
Duty to educate device managers
– Hospital failed to educate technicians in the
proper use of angiographic equipment.
Berg v. U.S., 806 F.2d 978 (10th Cir. 1986)
Duty to establish credentialing criteria
• Risk Management:
– Medical specialty societies
– Governmental, Ministry of Health guidelines
– Training program selection
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Devices in Court
Loss of evidence in malpractice case
warrants adverse interference
instruction. Williams v. Washington Hospital,
601 A.2d 28 (D.C. 1991)
Hospital entitled to witness destructive
testing.
Dina v. Lutheran, 548 N.Y.S.2d 541 (N.Y. App.
1989)
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XIII. Hospital Ethical and
Legal Responsibilities with
Medical Devices
Laws, Regulations, and Standards
Duty to Select Proper Equipment
Duty to Manage Equipment to
Ensure Safety
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