Medical Equipment and the Safe Medical Device Act (SMDA)

1. Medical Equipment and the Safe Medical Device Act (SMDA) Providence Health System - Oregon Environment of Care

2. Purpose The purpose of this course is to: • Promote the safe use of medical equipment. • Reduce the risk of patient or staff injury. • Report serious injuries quickly and accurately.

3. Learning Objectives Upon completion of this course, you will be able to: • Determine which department to call for equipment repair and maintenance. • Identify 3 simple steps to prevent patient injury caused by medical equipment. • State purpose of green and yellow repair tags. • Appreciate the importance of user training. • Identify 5 steps to comply with the SMDA.

4. What is Medical Equipment? The term “Medical Equipment” refers to: • Devices used in the diagnosis, treatment or monitoring of patients • Any piece of medical equipment used by or on the patient

5. Who Services Equipment? Clinical Engineering (Biomedical) and TSS Imaging are your main service providers in the hospital. In the Satellites, Cooperative Health Resources is the provider. They are part of Providence’s Technical Support Services. It’s part of Oregon’s Medical Equipment Management Plan. More details are found on their Intranet site: http://phsnet.phsor.org/tech_support/

6. The Plan In the hospitals, Clinical Engineering is in charge of the overall equipment program. Three departments provide inspection, repair and preventive maintenance. • Physical Plant • Hospital beds • Medical gas alarms • Wheelchairs • Clinical Engineering • Monitors, Infusion Pumps • Outside Vendors • Catheters, tubing, forceps • Items under warranty or special contracts Physical Plant maintains hospital beds. Cooperative Health Services is the medical equipment service group for the Satellites.

7. Every Piece of Equipment Must Have a Tag All Providence Medical Equipment must be inspected and tagged prior to use on a patient. • Remember: NO TAG = NO USE All patient care devices MUST have a Providence inspection tag. • All rental, loaned or demonstration equipment / accessories must be received and inspected by the appropriate medical equipment service group 24-hours before its intended use.

8. Before you use a device on a patient... Look for damage and test all equipment before its use on a patient. Pay particular attention to the power cord. If you suspect something is not functioning right or or appears damaged: • Remove the device from service. • Attach a Providence tag to the defective device. • Please give a detailed description of what is wrong. “Broke” is too vague. • Put the date, your name and your unit on the tag in case we need to ask any questions about how the equipment failed.

9. Top Priority Medical Equipment Inspection Tags Priority 1 Equipment: GREEN TAG Report overdue reinspection dates to your service group. Example: Ventilators, defibrillators Priority 2 Equipment: YELLOW TAG Report overdue reinspection dates to your service group. Example: Patient monitoring, electrosurgical units

10. Medical Equipment Inspection Tags Priority 3 Equipment: BLUE TAG Report to your service group when the piece is defective or broken. The equipment will be repaired / replaced at that time. Example: Intermittent suction, exercise equipment, etc.

11. Other Inspection Tags Additional tags are: • Inventory, Asset Management, Tracking Tags Ignore the inspection date on this tag. It will be updated after this device is repaired. • Tags on Demo/Rental Equipment Report overdue reinspection dates to your service group.

12. User Training Clinicians must demonstrate how to operate medical equipment safely before using it on a patient. All medical equipment requires user training. • Clinical engineering / TSS Imaging must file evidence of staff training for each medical device. • New equipment cannot be put in to service until all clinicians who will use the equipment have received training. • Training documentation is also required on all loaned devices and demonstration equipment.

13. Just Some TLC* Medical devices are very expensive. The large cost reflects the amount of research time and limited distribution. Please practice good Stewardship by doing the following: • Take time to handle a device with care. • When transporting devices, to not stack them on a cart. • If a device is dropped, report it so it can be inspected before use. * Tender Loving Care

14. Safe Medical Device Act The U.S. Food and Drug Administration (FDA) works with manufacturers and health systems to prevent injury and death from medical equipment. They all follow the federal law outlined in the Safe Medical Device Act (SMDA). Providence must investigate and report any device-related death or serious injury.

15. Safe Medical Device Act The Safe Medical Device Act increases the amount of information the FDA receives about medical device problems. With this information, the FDA can take appropriate actions to protect the public from hazardous medical devices.

16. FDA’s Definition of a Medical Device A medical device is... An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar article that is intended foruse in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease, or intended to affect the structure or any function of the body, and which does not achieve any of its principal intended purposes through chemical action within or on the body, and which is not dependent upon being metabolized for the achievement of any of its principal intended purposes.” Medical devices can be anything from thermometers to artificial hearts to at-home pregnancy test kits. -Federal Food, Drug and Cosmetic Act, Section 201

17. Implanted Devices Implanted devices that fail have to be reported. Surgically implanted devices that have been removed do not have to be reported.

18. SMDA: Patient Care First Employees play an important role in the SMDA reporting process. Before you start the report: • Stabilize the patient • Secure back-up or spare equipment • Locate and open an SMDA kit

19.  SMDA Kits The SMDA Kits contain the following items: Instruction Sheet with reporting instructions & phone numbers 1 Large Isolation Bag 1 Small Isolation Bag Unusual Occurrence Report (UOR) “Defective Do Not Use” & Biohazard Labels 2 Plastic Ties (for bags)

20. SMDA Kits SMDA kits should be available in your department or from Clinical Engineering. These kits are for your convenience. If the items contained in the kit are not necessary for your event, simply: • Fill out an Unusual Occurrence Report (UOR) • Follow the guidelines of the SMDA policy  

21. SMDA: Starting the Process • Complete an Unusual Occurrence Report (UOR) to start the SMDA investigation process. Fill out all appropriate areas, especially: • Condition of the patient • Identification of the device • Write the UOR number on all tags, bags and other paperwork. The UOR number links all documentation.

22. Reporting Defective Equipment • Write the device’s Providence asset or control tagnumber on the UOR. • If you cannot find the tag, use the serial number. • Copy the serial number exactly as you see it. Include any letters or leading zeroes (e.g. 00056678) • Remove the device from service. Attached a copy of the UOR. Do not dismantle or clean the device. This could affect the integrity of the investigation. • Save all disposables in a biohazard bag. Save any packaging that is available. Label all bags with the UOR number.

23. Quick Reporting Could Save Lives Fill out and turn in the UOR promptly. Providence has only ten days from discovery to file an SMDA report.

24. Not Sure if the Event Requires an SMDA? Please call your Quality Manager or Clinical Engineering Manager if you have any doubts on what is an SMDA event. When in doubt, fill it out (UOR)! • The SMDA committee will use the UOR to review the incident. • The SMDA committee meets within a couple days on urgent matters and at least quarterly.

25. For More Information For more information, refer to your Department Safety Flip Chart or talk with your Department Safety Coordinator or Manager. Check the Safety WebPages on the Intranet for: • Environment of Care (EOC) Manual • Contact information for your Safety Managers Use this Intranet link: http://phsnet.phsor.org/safety/