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device (medical device)

A medical device is defined as any instrument, apparatus, contrivance, implant or accessory that is used in diagnosis or treatment of disease or other medical conditions. Notes: - FDA will require most medical devices to carry a unique code that will allow easier identification & tracking of devices [1] in a system called unique device identification system (UDI) - UDI system consists of two core items - a unique number that identifies the device - publicly searchable database administered by the FDA, called the Global Unique Device Identification Database (GUDID) (No identifying patient information) - medical devices 1st approved in the European Union associated with more safety alerts & recalls than those 1st approved in the U.S. [5]

Specific

'quick-look' paddle accapela flutter valve accelerometer Active Care + SFT adaptive equipment adhesive strip; stiri strip air cleaner; air filter air pod; Apple air pod; AirPods Pro; earbud Air Purification System alpha stimulator ambulatory device ammunition (bullets ...) Amsler grid (AG) ankle foot orthosis (AFO) artificial heart (Jarvik-7, Jarvik-2000) AspireAssist device assistive listening technology audioscope balloon balloon tamponade battery bed alarm Betaconnect bioresorbable scaffold blood culture isolator (lysis centrifugation) blood pressure cuff blood pump (Impella 2.5 System) Bogota bag bougie BrainComputer Interface Device (IPSIHand) BrainPort V100 breathing entrainment device (RespErate) bronchial valve cam walker cannula caption phone (ClearCaptions, CapTel phone) car seat (child safety seat) cardiac assist device; ventricular assist device catheter cerebrospinal fluid drainage device cervical collar charge-coupled device (CCD) clamp device clot retrieval device (Trevo) combitube conduit contact lens (CL, CTL) controlled release (CR) cotton tip applicator; Q tip curette defibrillator dental floss dentures dermal microcoring device (Ellacor) diabetic supplies dialysis membrane diode DNA microarray scanner duct tape ECG lead electrode electronic device Embrace smart watch emery board endotracheal tube (ETT, tracheal tube) enteral tube epidermal electronic system (electronic skin, EES) epinephrine autoinjector (Epipen, Symjepi) eustachian tube balloon dilation system exophthalmometer exoskeleton assistance explosive device external fixation system (includes halo, cranial tongs) extracorporeal membrane oxygenator (ECMO) eye chart eye protective device eyeglasses (spectacle, glasses) face mask face shield fire extinguisher first aid kit fluorescent light generator GentleWaves glass slide glaucoma drainage device glove glucagon kit GlucoWatch gurney headphone hearing aid; digital hearing aid hemospray hemostat heparin lock (heplock) HiccAway hip protector house call bag hoverboard; self-balancing scooter iliac artery occlusion device implant incentive spirometer infant sleep machine; white noise machine inflatable vaginal device (Eclipse System) infusion pump inspiratory impedance threshold device insulin device (device for administering insulin) intermittent pneumatic compression device (IPC); synchronized compression device (SCD) intra-aortic balloon pump (IABP, intra-aortic balloon counterpulsation) intragastric balloon system (Orbera Intragastric Balloon System, ReShape Integrated Dual Balloon System) intrauterine contraceptive or device (IUD) ionized bracelet jet injector Jewett brace Kardiaband laboratory instrument Lancet laryngeal mask airway (LMA) laryngoscope LINX Reflux Management System Lukens trap magnetic sphincter device mandibular advance device manometer maze mechanical ventilator Medicare card metered dose inhaler (MDI) microarray motor vehicle airbag nasal cannula nasopharyngeal airway near infrared light scanner (Infrascanner) nebulizer needle Nerf gun Neti Pot (nose bidet) Neuropsychiatric EEG-Based Assessment Aid (NEBA) NSS-2 Bridge device obturator optical prism Optune device oral airway oral appliance orthosis otoscope pacifier patent foramen ovale (PFO) occlusion device (Amplatzer) personal digital assistant (PDA) pessary pillbox; medication organizer pillow portable sleep monitor prostatic coil-shaped device (coil) prosthesis pulmonary artery sensor pump with oxygenator or heat exchanger Q-collar compressive device radioisotope thermoelectric generator (RTG) retinal camara retractor scalp cooling system; cooling cap (DigniCap) scalpel Sea-Band seat belt self-expanding metal stent (SEMS) semiconductor sensor sharps container skateboard skeletal pin sling slit lamp smart socks specimen tube spirometer sponge standing scooter staple stent/stenting sternal occipital mandibular orthosis (SOMO) stethoscope Stimwave Freedom Spinal Cord Stimulation System stocking stylus support-surface (mattress, bed) surgical clip surgical probe surgical suture swab swath syringe television test kit thermistor tooth brush tourniquet tracheal cuff transcranial magnetic stimulator (TMS, Cerena TMS) treadmill trocar truss tuning fork tympanostomy tube vaginal mesh vaginal ring vehicle Venturi mask (Hudson mask, nonrebreathing mask) vial Vibrant vibrating capsule videogame wearable baby monitor wearable device wearable exoskeleton device

General

ENTITY

References

  1. FDA News Release: Sept. 20, 2013 FDA finalizes new system to identify medical devices. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm369276.htm
  2. FDA: Medical Devices http://www.fda.gov/MedicalDevices/
  3. FDA News Release. March 12, 2015 FDA releases final guidance on reprocessing of reusable medical devices. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm437804.htm
  4. CDC Health Advisory. Sept 11, 2015 Immediate Need for Healthcare Facilities to Review Procedures for Cleaning, Disinfecting, and Sterilizing Reusable Medical Devices. http://emergency.cdc.gov/han/han00382.asp - Centers for Disease Control and Prevention (CDC) Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008. http://www.cdc.gov/hicpac/pdf/guidelines/Disinfection_Nov_2008.pdf
  5. Hwang TJ, Sokolov E, Franklin JM, Kesselheim AS. Comparison of rates of safety issues and reporting of trial outcomes for medical devices approved in the European Union and United States: cohort study. BMJ 2016;353:i3323 PMID: 27352914 http://www.bmj.com/content/353/bmj.i3323
  6. Shuren J FDA is working with hospitals to modernize data collection about medical devices. FDA Voice. Posted Oct24, 2016 http://blogs.fda.gov/fdavoice/index.php/2016/10/fda-is-working-with-hospitals-to-modernize-data-collection-about-medical-devices/
  7. Resnic FS, Matheny ME Perspectives: Medical Devices in the Real World. N Engl J Med 2018; 378:595-597 PMID: 29443668 http://www.nejm.org/doi/full/10.1056/NEJMp1712001