1. 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: mbruley@ecri.org Web Sites: www.ecri.org www.mdsr.ecri.org

2. ©ECRI 2007 2 Laws, Regulations, and Standards Duty to Select Proper Equipment Duty to Manage Equipment to Ensure Safety

3. ©ECRI 2007 3 Why Risk Management for Ethical and Legal Issues? New Technologies New Settings Compliance - National or Local Directives Media Attention Lawsuits

4. ©ECRI 2007 4 Who’s responsible when accidents happen? Manufacturers Distributors/Sellers Hospitals Servicers Users - Physicians, Nurses, etc.

5. ©ECRI 2007 5 Medical device system Device Patient User Environment Accessories

6. ©ECRI 2007 6 What went wrong? What was the injury?

7. ©ECRI 2007 7 Duty to Warn/Informed Consent

8. ©ECRI 2007 8 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

9. ©ECRI 2007 9 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. )

10. ©ECRI 2007 10 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

11. ©ECRI 2007 11 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)

12. ©ECRI 2007 12 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)

13. ©ECRI 2007 13 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.

14. ©ECRI 2007 14 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

15. ©ECRI 2007 15 Off-label use Risk management: –Scientific studies supporting use –Availability of approved alternatives –Widespread use by others –Informed consent

16. ©ECRI 2007 16 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

17. ©ECRI 2007 17 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

18. ©ECRI 2007 18 Selecting and Providing Improper Equipment –incompatible suction and tracheal tubes Mather v. Griffin, 540 A2d 666 (Conn. 1988) Improper Components –mismatched knee prosthesis Florida Patient’s Fund v. Tillman, 453 So.2d 1376 (Fla. App. 1984) Alternate Parts and Supplies –improper disposables raises issue of negligence, not malpractice. Lamb v. Candler, 413 S.E.2d 720 (Ga. 1992)

19. ©ECRI 2007 19 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)

20. ©ECRI 2007 20 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 Gather safety information before you purchase Compare brands and models Evaluate user skills Health Devices, Health Device Alerts, et al

21. ©ECRI 2007 21 Selecting and Providing Absence of Equipment –Traditional: What is usual and customary in similarly situated hospitals providing that service. –Trend: What a reasonably prudent (tertiary care..rural…) would supply under the circumstances. End-tidal CO2 monitor standard in 1987 elective case. Washington v. Washington Hospital, 579 A.2d 177 (D.C. App. 1990)

22. ©ECRI 2007 22 Standard of Care Trend: –“Locality” to “National” –“Usual and customary” to “Reasonable” The degree of skill or competence that is expected of a reasonably competent hospital in the same or similar circumstances. Industry below standard –Compliance with prevailing industry standards may not be enough. Helling v. Carey, 519 P2d 981 (Wash. 1974)

23. ©ECRI 2007 23 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

24. ©ECRI 2007 24 Managing and Maintaining Medical Technology Management Critical Links with Patient Care –Technology Assessment –Tendering –Use –Multiple Activities in Many Departments

25. ©ECRI 2007 25 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

26. ©ECRI 2007 26 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)

27. ©ECRI 2007 27 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

28. ©ECRI 2007 28 Hazards and Recalls

29. ©ECRI 2007 29 Hazards and Recalls

30. ©ECRI 2007 30 Managing and Maintaining Knowledge of a hazard + Failure to act = Liability

31. ©ECRI 2007 31 Risk identification - products Overdue IPMs Safety committee reports Downtime Repeat repairs Calls for unneeded repairs Incident reports Service contracts Hazards and recalls Complaints Credentialing

32. ©ECRI 2007 32 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

33. ©ECRI 2007 33 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)

34. ©ECRI 2007 34 Spoliation of Evidence Risk Management: –Lawsuit filed? –Lawsuit threatened? –Request to preserve? –What’s the statute of limitations?

35. ©ECRI 2007 35 Laws, Regulations, and Standards Duty to Select Proper Equipment Duty to Manage Equipment to Ensure Safety XIII. Hospital Ethical and Legal Responsibilities with Medical Devices