2016 Annual Associate Safety Modules Section 7 Safe Medical Devices Act (SMDA)
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1 2016 Annual Associate Safety Modules Section 7 Safe Medical Devices Act (SMDA) Reporting Defective Medical Devices
2 WHAT IS S.M.D.A The Safe Medical Devices Act (SMDA) is a federal act designed to assure that all medical devices are implemented safely
3 What is a Medical Device? A medical device is anything used in patient care except drugs. For example...
4 EXAMPLES OF MEDICAL DEVICES ALL EQUIPMENT such as an IVAC, CP monitor, or blood filter ALL SUPPLIES such as syringes, gloves, or catheters ALL INSTRUMENTS such as scissors, hemostats, or clamps
5 Safeguard Event Submission Examples Allergic Reaction Burn During Surgery Cardiac Arrest (Adult or Pediatric) Diet: Food Poisoning Diet: Wrong Diet Dietary Allergic Reaction EMTALA Violation Equipment Disconnection Leading to an Adverse Event Fall/Slip of patients or visitors Surgical Perforation (any organ)
6 Safeguard Event Submission Examples Continued Hemodialysis Related Complication HIPAA Violation Hospital Acquired Hypoglycemia ID Bracelet/Band-Missing or Not Placed at Administration - ID Bracelet/Band-Wrong Band Placed at Admission IV Infiltration/Extravasation Lab: Delay in Test Results Due to Mechanical Issues Lab: Delay in Test Results Due to Sample Collection Issues Lab: Delay in Test Results Due to Specimen Processing Issues Lab: Mislabeled Specimen - 2 labels on tube, can identify original Lab: Mislabeled Specimen - only 1 label on tube (no other identification on tube) Lab: Non Labeled Specimen (unable to use)
7 Safeguard Event Submission Examples Continued Lab: Wrong Results Posted to Patient Record Left Against Medical Advice Left Without Being Seen Medical Device Malfunction Missed Treatment (Nonpharmaceutical) Missed Treatment (Respiratory Therapy - due to inadequate staffing, unavailability of medication or other reason patient NOT at fault) Treatment Respiratory Therapy Event Needlestick (patient) Newborn Apgar <5 Newborn Birth Injury Peritoneal Dialysis Related Complication Pharmacy: ADR
8 Safeguard Event Submission Examples Continued Pharmacy: Home Event: Ex: Patient on Warfarin at home, admitted with GI Bleed and INR of 6 Pharmacy: Allergic Reaction to Drug - Documented history of Allergy, but Received Drug Anyway Pharmacy: Look Alike/Sound Alike Issues Pharmacy: Medication Error - 5 R's Pharmacy: Medication Error Due to Decimal Point Error Pharmacy: Medication Error Due to Illegibility Pharmacy: Medication Reconciliation Issues Pharmacy: Physiologic Reaction to a Drug Combination Not previously known to illicit an adverse response Pharmacy: Physiologic Reaction to a Drug Combination with Known Interactions
9 Safeguard Event Submission Examples Continued Pneumothorax (Related to Central Line Insertion) Pulmonary embolism Respiratory Issues (Other) Respiratory: Unplanned Extubation Restraint Issues (Any) Shock from Medical Device Device Suicide Transfusion Reaction Unattended Delivery - Maternal Event Unplanned C-Section
10 Your Responsibility as an Associate/Physician following and event Step 1 Your First Priority! Attend to any immediate medical and safety needs of the patient or other involved individuals Step 2 Remove the device from service and label it as defective
11 Your Responsibility as an Associate/Physician following and event Step 3 Complete report in SafeGuard on Molli
12 SMDA Questions If you have any questions regarding the Safe Medical Devices Act, contact Risk Management
13 Event Reporting Associates may voluntarily report an SMDA event. Associates can call FDA You can also report by completing or mailing an FDA form which can be downloaded from The form can then be mailed in or faxed to FDA-0178.
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