XIII. Hospital Ethical and Legal Responsibilities with Medical Devices TRAINING SEMINAR ON MEDICAL DEVICE ACCIDENT INVESTIGATION for Kingdom of Saudi Arabia.

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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Medical device system

Device

PatientUser

EnvironmentAccessories

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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 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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Hazards and Recalls

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Hazards and Recalls

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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)

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Laws, Regulations, and StandardsDuty to Select Proper EquipmentDuty to Manage Equipment to

Ensure Safety

XIII. Hospital Ethical and Legal Responsibilities with

Medical Devices