1. Legal & Regulatory Issues for Biomeds rev 2016-03-16 this is now slide 1do not print it to pdf things to do (check off when complete): add revision date to cover page remove triangles create list for pages to print in the handout 2-9,11-18 add captions for photo slides incorporate notes taken during presentation add Key Points page 3 useful characters: ° degrees‎Ω ohmsμ microλ lambda ☑ checkbox ☐ slash-zero ØCO 2 O 2 SpO 2 N 2 O ® ™ trademarks à 224 E0 á 225 E1 â 226 E2 ã 227 E3 ä 228 E4 å 229 E5 æ 230 E6 ç 231 E7 Ð 208 D0 è 232 E8 é 233 E9 ê 234 EA ë 235 EB ì 236 EC í 237 ED î 238 EE ï 239 EF Ñ 209 D1 Ò 210 D2 Ó 211 D3 Ô 212 D4 Õ 213 D5 Ö 214 D6 Ø 216 D8 ß 223 DF Þ 222 DE Ù 217 D9 Ú 218 DA Û 219 DB Ü 220 DC Ý 221 DD Þ 222 DE ß 223 DF

2. Legal & Regulatory Issues for Biomed Technicians © D. J. McMahon 140312rev cewood 2016-03-16

3. Key Points Legal & Regulatory Issues for Biomeds: Liability Issues: Personal liability of a technician for incompetence or negligence Borrowing or lending medical equipment to another institution Use of alternative (non-OEM) repair parts or assemblies Guidelines for the biomed department when a medical device is involved in a patient morbidity or mortality - Protect patient(s) from any further risk - Leave settings in place, if possible - Leave equipment in place, if possible - Isolate the entire room, if possible - Communicate with the dept manager The Safe Medical Devices Act (SMDA) Who must report device-related incidents, and when? What form should be used to report a hazard or incident? What biomed records should be kept, and for how long? What information is discoverable in the event of a lawsuit? What types of medical devices should be “tracked” ? Three classes of FDA Recall: I, II, III Manufacturer's responsibility & Biomed Dept's responsibility involving a recall What if I have to be deposed ?

4. Liability Issues: Personal liability of a technician for incompetence or negligence - Employer hospitals have insurance that covers you -Same for Independent Service Organizations, and for manufacturers if working as a Field Service Tech. -If you are an independent technician, you should NOT provide services without some kind of liability insurance

6. Liability Issues: Borrowing or lending medical equipment to another institution -If you lend equipment that causes a morbidity or mortality, you may be part of a legal action -If you borrow equipment that causes a morbidity or mortality, you will likely be part of a legal action

7. Liability Issues: Use of alternative (non-OEM) repair parts or assemblies Use caution, especially with proprietary components or assemblies.

8. Liability Issues: Guidelines for the biomed department when a medical device is involved in a patient morbidity or mortality - Protect patient(s) from any further risk - Leave settings in place, if possible - Leave equipment in place, if possible - Isolate the entire room, if possible - Communicate with the dept manager

9. Critical Biomed Equipment Groups : Life Support:Invasive, non LS: Emissive, non LS: ventsdialysis lasers defibsautotransfusors warming devices anesth machinesmed delivery pumps x-ray generators perfusion pumpsinsufflators ultrasound generators balloon pumps electrosurgical units audiometers Passive Biomed Equipment Group: ECG, EEG, HR, SpO 2, NiBP, IBP, CO, Temp, resp gases, flowmeters video systems: camera processors, displays, etc surgical microscopes clinical lab equipment PT equipment: treadmills, etc

11. The Safe Medical Devices Act (SMDA) Who must report device-related incidents, and when?

12. The Safe Medical Devices Act (SMDA) What form should be used to report a hazard or incident? See FDA’s Form 3500A (for mandatory reporting) http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM048334.pdf

13. The Safe Medical Devices Act (SMDA) What biomed records should be kept, and for how long? -Maintenance records of any type (PM, repair, upgrades, modifications, installs - For at least 21 years

14. The Safe Medical Devices Act (SMDA) What information is discoverable in the event of a lawsuit? Virtually anything pertinent to an investigation.

15. The Safe Medical Devices Act (SMDA) What types of medical devices should be “tracked” ? -Implants -Devices used outside of the user facility (eg home healthcare, etc)

16. Biomed Awareness: Three classes of FDA Recall Class I recalls are for dangerous or defective products that predictably could cause serious health problems or death. Class II recalls are for products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Class III recalls are for products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing regulations.

17. Biomed Awareness: Timely notification of an FDA recall: “How was I supposed to know?” -It is the manufacturer’s responsibility to notify the users of significant recalls. (Not the FDA. They start a recall through the manufacturer.) -It is the CE department’s responsibility to maintain accurate records of the equipment, and to act on any notice they receive.

18. What if I have to be deposed ? http://www.lawyer.com/a/12-rules-to-follow-when-you-are-being-deposed.html