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2. IN-SERVICE TRAINING Topics Covered: Safe Medical Devices Act (SMDA) Infection Control Exposure Risk Management 2

3. SMDA – Safe Medical Devices Act The Safe Medical Devices Act (SMDA) is a federal act designed to identify any medical device problems that pose a threat to public health and safety. 3

4. Learning Objectives Define “medical device” Discuss how to report incidents involving medical devices Discuss the types of events that must be reported 4

5. What Is A Medical Device? A medical device is any piece of equipment used in patient care EXCEPT drugs. Hospital Beds Wheelchairs Oxygen Walkers, Canes Catheters Air mattresses Hoyer Lifts Suction Equipment Artificial Limbs Wound Vacs 5

6. What Is A Serious Injury? Life threatening Results in permanent impairment or damage to a body structure or function Necessitates medical or surgical intervention to prevent permanent impairment or damage 6

7. What Is Your Responsibility? Inspect assistive equipment/medical devices on each visit Instruct patients not to use broken equipment until it is repaired or replaced Tag broken equipment DEFECTIVE – DO NOT USE Report broken equipment to the medical equipment company and to your supervisor CALL 911 AND NOTIFY THE OFFICE IMMEDIATELY IF A PIECE OF MEDICAL EQUIPMENT HAS CAUSED SERIOUS INJURY 7

8. What Is The Agency’s Responsibility? To report any event to the FDA where a medical device has resulted in serious injury or death To maintain records of all incidents involving medical devices To educate staff annually regarding the requirements of SMDA 8

9. Infection Control and Exposure Risk Management Many of the clients that you will work with as a caregiver will be vulnerable to catching diseases. To protect yourself and your client from exposure, you will take standard precautions with every client. For these methods to be effective, they must be used consistently! 9

10. Learning Objectives Identify risk factors for infection Discuss different ways infections are transmitted Identify ways to protect the client and yourself from exposure and prevent the spread of infection 10

11. Risk Factors for Infection Very young or very old age Poor general health Stress and fatigue Indwelling medical devices 11

12. Ways Infections Are Transmitted Through the air Through contact with an infected person or objects that the person has used. Through bodily fluids (urine, feces, saliva, blood, wound drainage) Sweat and Tears are NOT infectious Needlesticks, cuts from contaminated glass, and splashes and sprays of contaminated body fluids can put a health care worker at risk for a bloodborne disease. 12

13. How To Protect Yourself and Your Client Gloves, gowns, masks (PPE) must be worn if the possibility exists that you could come in contact with blood or other body fluids. Handwashing is the most important method of preventing the spread of infection. If accidental exposure to blood or other body substances occurs, hands must be washed thoroughly and immediately. Sharps, such as used needles, razors or broken glass must be disposed of properly. Contaminated, broken glass should not be handled, even with gloved hands. They should be swept or vacuumed up for disposal. 13

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