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XIII. Hospital Ethical and Legal Responsibilities with
Medical Devices
TRAINING SEMINAR ONMEDICAL DEVICE
ACCIDENT INVESTIGATIONfor
Kingdom of Saudi ArabiaSaudi Food & Drug AuthorityRiyadh 11-14 February, 2007
Presenter:
Mark E. BruleyVice President, Accident and Forensic InvestigationECRI5200 Butler Pike, Plymouth Meeting, PA, 19642 USATel: +1 610-825-6000, ext. 5223 E-mail: [email protected] Sites: www.ecri.org www.mdsr.ecri.org
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Laws, Regulations, and StandardsDuty to Select Proper EquipmentDuty to Manage Equipment to
Ensure Safety
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Why Risk Management for Ethical and Legal Issues?
New TechnologiesNew SettingsCompliance - National or Local
DirectivesMedia AttentionLawsuits
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Who’s responsible when accidents happen?
ManufacturersDistributors/SellersHospitalsServicers Users - Physicians, Nurses, etc.
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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 DevicesMay 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. 94-1478 (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 pumpsPenile prosthesesAngioplasty
cathetersClip applicatorsVentilatorsDefibrillatorsSuture Units
Pacemakers and leads
Intra-aortic balloon pumps
Urethral sphincter prostheses
Heart valves
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Hospital Responsibilities
Duty to maintain a safe workplaceDuty to select/provide safe productsDuty to manage and maintainDuty to use products properlyDuty to educate/credentialDuty to warn of risksDuty 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 ProvidingHow 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• 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– 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 ManagementCritical Links with Patient Care
– Technology Assessment– Tendering– Use– Multiple Activities in Many Departments
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Managing and Maintaining
Self-Assessment Questionnaire– 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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Risk identification - products
Overdue IPMsSafety committee reportsDowntimeRepeat repairsCalls for unneeded repairs Incident reportsService contractsHazards and recallsComplaintsCredentialing
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Education and Credentialing
Duty to educate device usersDuty 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)