A
As and Bs
Short for apnea and bradycardia
Abiomed Impella
World’s smallest heart pump – percutaneous cardiac assist which means that the doctors can insert the device through the skin
ACE
Adverse Clinical Event
Acidosis
Condition in which there is too much acid in the bloodstream
ACE
Adverse Clinical Event
ACR-NEMA Standard
Detailed specification system for the exchange of information between medical imaging devices
ATMP
Advanced Therapy Medicinal Products
AIMD
Active implantable medical device
Adulterated Device
Medical devices are subject to the provisions of the FD&C Act under Section 501. A device is held to be adulterated if it includes any filthy, putrid, or decomposed substance, or if it is prepared, packed or held under unsanitary conditions
Angiocath
Type of intravenous catheter
Anemia
A state in which there are not enough red blood cells in the body
Antibiotics
Drugs used to kill or slow the growth of bacteria that cause infections
ANSI
American National Standards Institute
AICD
Automatic implantable cardioverter defibrillator
Ambient temperature
Surrounding temperature; temperature encompassing on all sides
Ampoule or Ampule
A small glass vial sealed after filling and one of the earliest devices developed for safe storage of a sterile injectable unit
AO
An Auditing Organization is responsible for auditing medical device manufacturers to evaluate conformity with quality management system requirements and other medical device regulatory requirements. An AO may be an independent organization or a Regulatory Authority
Apnea
A pause in breathing, lasting more than 15 to 20 seconds, that is associated with the patient color changing to pale, purplish or blue and often associated with bradycardia
Arrhythmia
Abnormal heart rhythm – usually due to faulty conduction of electricity through the heart
Artery
A blood vessel that carries oxygenated blood from the heart to the rest of the body
Aseptic packaging
Aseptic packaging: a system in which the product is sterilized before filling into pre-sterilized packs under aseptic conditions
ASL
An Approved Supplier List, or ASL is an internal list kept by medical device manufacturers to record suppliers known to meet the quality and performance standards of the manufacturing organization
Aspiration
Inhaling of material into the windpipe and lungs
ASTM
American Standards for Testing and Materials
ATM
Abbreviation for standard atmospheric pressure
B
Beall valve
Type of prosthetic heart valve
Bar
A unit of pressure. The bar is equal to 100,000 Pa (pascal), 750.062 mmHg, 29.53 InHg, 14.504 psi and 0.987 ATM (standard atmospheres)
Barrier Plastics
Plastics that impede the passage of oxygen, water vapor, and other vapors and gasses
BFS
Blow Fill Seal
BiVAD biventricular assist device
implantable pump designed to help the heart function better when both sides of the heart are failing
Bi-pap
A device that provides ventilation for patients by delivering air to the lungs at two levels of pressure, either cyclically in an anesthetized patient or triggered by the patient’s attempts at breathing when awake
Bilirubin (Bili)
A pigment in blood cells that causes jaundice
Biologics
Any virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product
Blister Pack Package
With multiple small compartments for individual products
Boxed Warning
This type of warning is also commonly referred to as a “black box warning.” It appears on a prescription drug’s label and is designed to call attention to serious or life-threatening risks
Blood Gas
A test that measures the level of oxygen and carbon dioxide in the blood
Bradycardia
A heart rate less than 100, slower than normal for an infant
Bridge to transplant
When a VAD is implanted while waiting for a heart transplant
C
Calcium
A chemical element necessary for the normal function of the heart, nerves, and bones
Cannula
Cannula is a short flexible tube which is introduced into a blood vessel, while Catheter is defined as a tube which is substantially longer than Intra Vascular Cannula for peripheral access to body
Cannula/Needles and Flow Selection/Regulation Devices
Pathway for the administration or collection of solutions, blood, and fluids. Typical manufacturing issues are related to adhesive bonding, extrusion
CAPA
Corrective Action Preventive Action
Cardiac
Relating to the heart
Cardiology
The medical specialty dealing with the heart and circulatory system
Catheter
Plastic tube used for giving or removing fluids – Non-Compliant Balloon Catheters: Used in stent delivery, PTA/PTCA, dilation, and more. Test methods vary slightly for stented vs non-stented versions but both can be managed by the same instrument. Multi-Lumen Catheters: Used in hemodialysis, diagnostics, pacing, drug delivery, CVC, PICC, and various other applications – ISO 10555 Catheter Testing
Cat’s whisker
The sharp-pointed protrusion from a blister that can arise when using a cross-cutting blade and slitter to cut out individual packs on a form fill seal machine
CB
Cardiopulmonary bypass devices
CBC
Complete blood count, a test conducted to detect infection, anemia, or other conditions
CBM
A cardiopulmonary bypass machine s commonly known as a heart-lung bypass machine
CCI
Container Closure Integrity
CCO
Continuous Cardiac Output
CCS
Container Closure Systems
CE Marking or CE Mark
Certification must be obtained by medical device manufacturers for product distribution into the European Union (EU) marketplace. CE Marks are issued by third-party organizations, known as a Notified Bodies, and indicate compliance with the applicable EU medical device regulations (MDR)
CDER
Center for Drug Evaluation and Research
CDRH
Center for Devices and Radiological Health
CBER
Center for Biologics Evaluation and Research
Central Line
Special intravenous (IV) line placed in a large vein that goes to the heart. Can be used to give high levels of nutrition
CER
A Clinical Evaluation Report, or CER, provides clinical evidence that a medical device will perform as expected, such that no safety issues occur while using it. European regulations require medical device manufacturers to perform a conformity assessment, of which include CER documentation, in order to legally market a product in the EU
CFR
Code of Federal Regulations
Cgmp
Current Good Manufacturing Practice
CVA Cerebrovascular accident
stroke is usually caused by atherosclerosis, the same process that leads to coronary heart disease, including heart attacks. The second form is caused by the rupture of a blood vessel supplying the brain. This is known as a hemorrhagic stroke
Check Valves Medical One-Way
Used in drug/fluid delivery, hemodialysis, blood transfer, and more. Different tests can be performed, including anti-reflux valve leak, body weld leak, below cracking pressure valve leak, above cracking pressure valve opening verification
Chemstrip
A blood test to determine blood sugar level
Chest Tube
A small plastic tube inserted into the chest to withdraw air or fluids that have escaped from the lungs into the chest cavity. The chest tube may be connected to suction equipment
Combination product
Healthcare products (drug plus device, biological plus device, drug plus biological product, or drug plus device plus biological product)
Cope loop catheter
Type of catheter with a mechanism for holding the distal end of the catheter in a locked pigtail configuration to prevent accidental catheter removal
Chronic Lung Disease
Changes in the lungs that have occurred due to long term mechanical ventilation
Class 1 – Med Dev
The US FDA defines Class I devices as devices that are “not intended for use in supporting or sustaining life or of substantial importance in preventing impairment to human health, and they may not present a potential unreasonable risk of illness or injury e.g. Electric Toothbrush /Oxygen Mask / Reusable Surgical Scalpel /Bandages
Class 2 – Med Dev
The FDA defines Class II devices as “devices for which general controls are insufficient to provide reasonable assurance of the safety and effectiveness of the device. Examples are Catheters /Blood Pressure Cuffs /Pregnancy Test Kits /Syringes / Blood Transfusion Kits / Contact Lenses / Surgical Gloves /Absorbable Sutures
Class 3 – Med Dev
The FDA defines Class III devices as products which “usually sustain or support life, are implanted or present a potential unreasonable risk of illness or injury. Examples are Breast implants / Pacemakers / Defibrillators /High-frequency ventilators /Cochlear implants / Foetal blood sampling monitors /Implanted prosthetics
Colostomy
Surgical opening of a small part of the intestine brought to the surface of the abdomen. It is performed when there is an obstruction or disease of the intestine
Congenital
Present at birth
Congestive Heart Failure
A condition that results when the heart cannot pump strongly enough
COPD
A catch-all term for a number of respiratory diseases. The diseases of COPD include chronic bronchitis, pulmonary emphysema, asthma, and bronchiectasis
Coudé
Coudé (French for elbowed) catheters have a 45° bend at the tip that facilitates easier passage through an enlarged prostate – Defective catheters may be supplied, which break in situ. The most common fractures occur near the distal end or at the balloon
CPAP
Continuous positive airway pressure provided by a ventilator to keep lungs from collapsing
CPP
Critical process parameter
CCP
Critical control points
Criterion
A requirement on which a judgement or decision can be based
Culture
Test of blood, urine, spinal fluid and tracheal secretions to check for infection
Cglp
Current Good Laboratory Practice
Cyanosis
Bluish coloration of the skin and lips due to low oxygen in the blood
CQA
Critical Quality Attributes
D
DFM
Design For Manufacture
Destructive
Sample cannot be subsequently used in any other analytical method or processed to a final product
Diaphragm
A muscle in the body that separates the chest cavity from the abdominal cavity
Diaphragmatic Hernia
A defect or hole in the diaphragm that allows the abdominal contents to move into the chest cavity
De Novo Classification
The De Novo classification pathway under section 513(f)(2) of the FD&C Act, establishing an alternate pathway to classify new devices into Class I or II that had automatically been placed in Class III after receiving a Not Substantially Equivalent (NSE) determination in response to a 510(k) submission. In this process, a sponsor who receives an NSE determination may, within 30 days of receiving notice of the NSE determination, request FDA to make a risk-based classification of the device under section 513 of the Act
Deming Cycle
Methodology for monitoring quality efficacy and serves as a basis for traditional quality assurance
Design Controls DC
All manufacturers (including specification developers) of Class II and III devices and select Class I devices are required to follow design controls [§820.30] during the development of their device. The design control requirements are basic controls needed to ensure that the device being designed will perform as intended when produced for commercial distribution
DD
A Design Dossier includes all contents of the technical file (TF), which describe a device’s design, manufacturing, and performance, as well as the documentation that demonstrates conformity with applicable regulatory requirements
Destination therapy
People who aren’t candidates for a heart transplant – the use of a left ventricular assist device
Distal Access Catheter
Intended for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vascular systems
DME
Durable medical equipment
DPI
Dry powder ingredient – a dry-powder inhaler (DPI) is a device that delivers medication to the lungs in the form of a dry powder. DPIs are commonly used to treat respiratory diseases
E
EAN
European Article Number and now used to denote International Article Number and the International Article Numbering Association
ECMO
Extracorporeal membraneous oxygenation, a procedure used to treat a variety of conditions such as sepsis, pneumonia, diaphragmatic hernia, and meconium aspiration
Edema
Presence of abnormally large amounts of fluid in the tissues of the body
EDS
Engineering Design Specification
EIR
Establishment Inspection Report, or EIR, is made by FDA in the event Form 483 is issued following an inspection. The next steps after receiving an official EIR from FDA will be determined by the severity of the issues observed, as well as the 483 responses. If significant deficiencies are observed, FDA may decide to issue a warning letter
ECG
Electrocardiogram (EKG or ECG) – A record of the electric current produced by the heart muscle to evaluate the heart’s structure and function
Electrolytes
Elements in the blood, such as potassium and sodium, needed for the body to work well
EM
Environmental Monitoring
EMC
Electromagnetic Compatibility (EMC)
Endoscope
A flexible tube with a light and camera attached to it that surgeons use to look at organs during a procedure. Because this is an electronic product with sealed lights and cameras that will be put into an area of moisture, it is important that the endoscope is completely air-tight
Endoscopic Suction Pump
Designed for endoscopic aspiration
Endocarditis
Endocarditis (an infection in heart tissue)
ETT
Endotracheal Tube (ETT) – Tube that goes through the mouth into the windpipe so a ventilator can provide breathing support
EpiPen
Needle fitted into a tube that looks like a pen, used for putting a drug into someone who is having a severe allergic reaction
ERP
Enterprise Resource Planning, or ERP, refers to the management of business processes within the organization of a medical device organization
EUA
EUA – Emergency Use Authorizations
Eutectic Plates
Used inside temperature-controlled packaging solutions as phase change material
EU MDR
Medical Device Regulation
F
Failure analysis
logical, systematic examination of an item to identify and analyze the probability, causes, and consequences of potential and real failures
FEA
Finite Element Analysis – A computerized method for predicting how a product reacts to real-world forces, vibration, heat, fluid flow, and other physical effects
FDA 21
FDA 21 CFR Part 11 sets out how a company operating in the US can use electronic quality records and digital signatures in place of paper-based documentation and ‘wet signatures’ in a compliant way
FPM
Fine particle mass (FPM)
FISTA
International Safe transit association
FMEA
The method used to identify failures in a design or process associated with a medical device. FMEA is distinct from ISO 14971, the international standard for medical device risk management. The FMEA method can be broken into two parts: PFMEA for processes, and DFMEA for designs
FSCA
Field safety corrective action FSCA – action taken by a sponsor of a medical device to reduce a risk of death or serious deterioration in the state of health associated with the use of a medical device
FILVAS
Fully Implantable Left Ventricular Assist System
Flow- Rotaflow, CentriMag, and CardioHelp
Flow- Rotaflow, CentriMag, and CardioHelp – external continuous flow devices. This means they sit outside the body and help the body circulate blood so that organs don’t shut down
FFS
FFS – form, fill, seal
French scale
The scale used for denoting the diameter of catheters, tubes, and sounds. Each French unit approximates 0.33 mm in diameter
FTA
Fault Tree Analysis is an analytical method aimed at identifying points of failure and risk within a quality system. In medical device manufacture, FTA can be applied throughout the course of risk management activities to identify possible sources of risk
FTO
Freedom to Operate refers to product infringement on intellectual property. Device manufacturers typically declare whether they have FTO in each market in which they plan to sell a new product
G
GAMP
Good Automated Manufacturing Practice
Gastrostomy tube
Tube surgically, percutaneously, or endoscopically placed into the stomach through the anterior abdominal wall and used for long-term administration of feedings
Gauge
Measuring device indicating amount, size, or power of a given object. The Birmingham gauge is a wire gauge system and is also used to specify the thickness or diameter of hypodermic needles and tube products
GCP
Good Clinical Practices
GDocP
Good Documentation Practice
Glucose
Sugar is the main source of energy for the human body
GMDN Code
The Global Medical Device Nomenclature (GMDN) code is an international system used to describe medical devices. A GMDN code is a 5-digit number that references a text description of the device
GMP
Good Manufacturing Practices (GMP) – current GMP requirements for medical devices are incorporated into a quality system regulation. The quality system regulation includes requirements related to the methods used in, and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing, and servicing medical devices intended for human use. This action is necessary to add preproduction design controls and to achieve consistency with quality system requirements worldwide
GOST
GOST refers to a set of technical standards maintained by the Euro-Asian Council for Standardization, Metrology and Certification (EASC)
Gram
The basic unit of weight in the metric system. There are 28 grams in an ounce
Groshong catheter
Specialized type of central venous catheter with a three-position valve near its tip. The valve allows fluid flow into and out of the catheter but remains closed when the catheter is not in use
H
HACCP
Hazard analysis critical control point (inspection technique)
Hall-Kaster valve
Type of prosthetic heart valve
Hawkins catheter
A self-retaining accordion catheter that assumes a Z configuration after the self-retaining device has been engaged
Headspace
Laser-based Headspace Analysis
HID
Hazard Identification is a risk management process in which device manufacturers determine whether situations, processes or items associated with the production of their device may have the potential to cause harm
Hemic
Hemic (hem/ic) means pertaining to or of the blood
Heel Stick
Used to obtain blood samples by pricking the heel of the baby
Hematocrit
A test used to measure the percentage of red blood cells in the blood
HLM
Heart-lung machine
Hub
Catheter refers to the central venous catheter (CVC) Hub refers to the end of the CVC that connects to the blood lines or cap. Cap refers to a device that screws on to and occludes the hub. Limb refers to the catheter portion that extends from the patient’s body to the hub.
Hubless needle
Some custom applications require just the cannula from a standard needle. This category of needles comes without a hub so they cannot be connected to a syringe. The length of the tubing can be specified at the time of order
Hydrocephalus
Excess fluid in the brain
Hyperalimentation TPN Hyperalimentation (TPN)
Administration of intravenous (IV) fluid with nutrients for babies who cannot be fed
Hypoglycemia
Blood sugar level below normal
Hypotension
Abnormally low blood pressure
Hypoxia
Oxygen level below normal
I
IABP
Intra-Aortic Balloon Pump
ICD
ICD Implantable Cardiac Defibrillator related to Cardiac Resynchronization Therapy
IDE
An Investigational Device Exemption allows the investigational device to be used in a clinical study to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and Drug Administration
IFU
Instructions for Use, or IFU, are instructional materials used to convey relevant information to the end-user
Ileostomy
Creation of a surgical opening through the abdominal wall into the ileum or small intestine. Fecal matter drains through this opening into a bag on the abdomen
Injectate
Injectate delivery system works effectively with room temperature or cold injectate for the measurement of bolus thermodilution cardiac output when used with a compatible monitoring platform and Catheter
In vivo
The term in vivo refers to a medical test, experiment, or procedure that is done on (or in) a living organism, such as a laboratory animal or human
In vitro
In the glass, as in a test tube. An in vitro test is one that is done in glass or plastic vessels in the laboratory. In vitro is the opposite of in vivo
INTERMACS
Interagency Registry for Mechanically Assisted Circulatory Support
IV
Intravenous (IV) — Introduction of fluid into a vein through a catheter
Isolette
An incubator
IS
incentive spirometer device to use often to help expand lungs and prevent pneumonia
IV Drip
A drip for putting liquid into the body
IVCT
In vitro clinical test
IVD
In vitro diagnostic product
IVDR
The IVDR is a regulatory directive for manufacturing and placing on the market in vitro diagnostic medical devices on the European Single Market
J
Jaundice
The yellow color of the skin due to an excess of bilirubin in the body
K
Kilo (Kilogram)
Unit of weight in the metric system. One kilo is equal to 2.2 pounds and 1,000 grams is equal to 1 kilo
L
LASIK
LASIK Surgical Machines – The use of LASIK technology is used primarily for the treatment of eye conditions.
LOD
Limit of detection
Lumbar Puncture
A small needle inserted into the spinal canal to obtain a sample of spinal fluid for testing
Lytes
Short for electrolytes
Lumen
The cavity or channel within a tube such as a blood vessel or the intestine
LVAD – Left Ventricular Assist Device
A surgically implanted, electrically (battery) powered pump that helps a failing heart’s left ventricle pump adequate amounts of blood to the body
LVP
Large Volume Parenteral (LVP) bags, glass or plastic ampoules
Lymphedema Pump
A pneumatic compression device for lymphedema consists of an air pump and a sleeve that fits over your extremity, typically your legs or arms
Lyophilized drug
Freeze-dried drugs. Vaccines are transformed from liquid to solid powder. This process enhances the shelf-life and stability of vaccines
VAD Ventricular assist device
Also known as a mechanical circulatory support device
M
Maglinte tube
An intestinal tube placed in the duodenum or jejunum for performing enteroclysis. It has an expandable balloon used to occlude the bowel lumen to prevent reflux of fluid into the stomach
MALL
Max allowable leak
MAP
MAP Modified atmosphere packaging
MA
MA Holder means the entity that holds the Marketing Approval for a product in a given country.
MAUDE
Manufacturer and User Facility Device Experience, or MAUDE, is a database for medical device electronic reporting (eMDR) submitted to the FDA by manufacturers, importers, device user facilities, health care professionals, patients, and consumers
MDR
Medical Device Report (USA)
MDV
Medical Device Vigilance (EU)
MDI
Metered dose inhaler (MDI) Inhaled respiratory medications are often taken by using a device called a metered dose inhaler, or MDI. The MDI is a pressurized canister of medicine in a plastic holder with a mouthpiece
MRP
Manufacturing Resource Planning is a way of compiling, organizing, and planning various activities carried out by a medical device manufacturer
Meconium
Dark green material in the intestines at birth, which is the first stool a baby passes
Medical Device
Any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes
Medical filters
Used throughout medical devices like respiratory, IVs, drip chambers, blood analyzers and manifolds, in order to filter gasses or liquids according to specifications
Medical fitting
Valves and connectors used to connect medical devices and tubing together push-in fittings, quick-couplings, disconnects, and Luer fittings. These connectors come in various shapes, sizes, and materials like Nylon, Kynar, Polypropylene, and metal. If these fittings do not connect properly to the medical devices, the devices will not perform efficiently and there could be serious consequences
Medical tubing
Component for many medical and pharmaceutical devices. The tubing manages the drainage and fluid of liquid in medical equipment like IVs, catheters, pumps, respiratory, anesthesiology, and biopharmaceutical lab equipment. Medical tubing can vary in size, material, and performance specifications. Tubing can be made of plastic, rubber or metal depending on the performance properties like hardness, flexibility, abrasion resistance, and durability
Meningitis
Infection of the membranes of the spinal cord or brain, caused by bacteria, viruses, or other organisms that reach the membranes by blood or trauma
Microfluidic Chips
Also known as lab-on-a-chip- used in a multitude of biological diagnostic applications, including analytical separation, detection, fluid control such as sampling/mixing
Micron
Unit of thickness measurement One micron is equal to 3.93 x10-5 inches (1×10-6 meter)
Milligram
Unit of weight in the metric system used to measure some drug doses. There are 1,000 milligrams in 1 gram
Monitor
Electronic equipment used to continuously monitor the heart rate, respiration, and blood pressure of the baby
MSDS
Material Safety Data Sheet
Murmur
An abnormal sound made by the heart or in the major blood vessels that may or may not be a problem
N
Nanomaterial
Means a natural, incidental, or manufactured material containing particles in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1-100 nm
Nasal CPAP
Nasal continuous positive airway pressure (CPAP) machines deliver air through specially designed nasal prongs. The machine does not breathe for the baby, but the flow of air creates enough pressure to keep the airway open
Negative predictive value
The ability of a device to separate true negative results from false-negative results for a given attribute in a given population
NIH
National Institutes of Health (U.S.)
Nondestructive
A method in which passing sample can be subsequently utilized in additional analytical methods
NPWT
Negative Pressure Wound Therapy – wound V.A.C therapy, this device uses negative pressure through a controlled suction to close large wounds and promote faster healing.
NPRA
New Product Risk Assessment
NDT
NDT–nondestructive testing
Nonsignificant Risk
Nonsignificant Risk, or NSR, is a measure of risk as outlined by ISO 14971
O
OBL
Own Brand Labeling occurs when a manufacturer sells a medical device in the EU that already has a CE Marking and does so under its own brand
Ostomy Supplies
Pouching systems may include a one-piece or two-piece system. Both kinds include a faceplate/flange (barrier or wafer) and a collection pouch. The pouch (one-piece or two-piece) attaches to the abdomen by the faceplate/flange and is fitted over and around the stoma to collect the diverted output, either stool or urine. The barrier is designed to protect the skin from the stoma output and to be as neutral to the skin as possible
Oximetry
The oximetry system continuously monitors oxygen saturation, noninvasively
QbD
Quality by design
OC
Oxygen Concentrator – Electronically powered device with a series of filters that extract oxygen from room air
Ocs
Oxygen Conserver – A type of regulator, which conserves the amount of gaseous oxygen in portable cylinders. Oximetry testing is required to ensure proper oxygen saturation during the use of a conserver
OES
Optical Emission Spectroscopy
OIP
Orally inhaled products
P
Package integrity
Ability to prevent product loss or maintain product sterility
PAL
Pharmaceutical affairs law
Parenterals
Medicine is taken into the body or administered in a manner other than through the digestive (alimentary) tract, as by intravenous or intramuscular injection. Total parenteral nutrition (TPN) is meant to drip through a needle or catheter placed in a vein. TPN is used for patients who cannot or should not get their nutrition through eating
PAT
Process Analytical Tech
PCR
Polymerase chain reaction (PCR) is a method used to rapidly make copies (complete copies or partial copies) of a specific DNA sample, allowing scientists to take a very small sample of DNA and amplify it to study in detail
Percutaneous Heart Pumps
Tiny heart pumps are placed in the heart via a thin tube called a catheter that is threaded through a puncture site in the skin. Open-chest surgery is not required for placement of a percutaneous heart pump
PDA
PDA Parenteral Drug Association
Perfusionist
A person who runs a cardiopulmonary bypass pump
PEMS
Programmable Electrical Medical Systems PEMS
PC02
A measure of carbon dioxide in the blood
PO
Per Os (by mouth)
Pneumonia
Inflammation of the lungs caused by infection or aspiration
Pneumothorax
Condition in which air escapes from the lungs into the chest cavity and compresses the lungs
PO2
A measure of oxygen in the blood
PoP
Proof of Principle
Polycythemia
Too many red blood cells in the blood
Positive predictive value
The ability of a device to separate true positive results from false-positive results for a given attribute in a given population
Potassium
One of the body’s electrolytes
Probabilistic Leak test method
The converse of the deterministic method, stochastic in nature, relies on sequential events
PRRC
According to Article 15 of the MDR, Authorized Representatives, and small manufacturers must designate at least one staff member responsible for ensuring MDR and/or IVDR compliance known as the PRRC
Proximal and Distal
They describe the position of a structure with reference to its origin – proximal means closer to its origin, distal means further away
Pulmonary Artery
A large blood vessel that carries unoxygenated blood from the heart to the lungs
Pulmonary Hypertension
Increased blood pressure to the lungs makes it difficult for the lungs and heart to provide enough oxygen to the body
PUPSIT
Pre-use Post Sterilization Integrity Testing
Pumps – Impella and TandemHeart
The Impella pulls blood from the left ventricle through the catheter and ejects it into the aorta. The TandemHeart takes oxygenated blood from the upper left chamber of the heart (left atrium) and deposits it in the femoral artery in the leg to be circulated throughout the body
Analgesia Pumps
Analgesia Pumps are for short-term dosages of specific medications and are controlled by patients to pump their own monitored dosage. Syringe pumps deliver small doses of high concentration medications over the course of a longer period of time
R
RBP
Rated burst pressure (RBP) and leak test methods
Recalls
Action needed when the FDA doesn’t approve of a food or drug item. If it doesn’t fit into the guidelines for the safety and efficacy of pharmaceuticals, the company often will recall the item themselves, but in serious situations, the FDA will have to inform the public. Class I recalls – the reasonable probability that it’ll cause injury or death. Class II – exposure may cause temporary injury. Class III – unlikely to cause adverse health reactions, but just wrong labeling or manufacturing regulations
Red Blood Cells
Cells in the blood that contain hemoglobin and carry oxygen
Repeatability
The measure of the accuracy of a system and the testing method used. A highly repeatable system will provide very consistent results
Residual
Amount of formula remaining in the baby’s stomach after a reasonable amount of time
Respiratory Breathing Tube / Circuit
Often manufactured from corrugated polymer tubing, common variants include single limb, dual limb, coaxial in both heated and non-heated variants
Respirator
A machine, sometimes called a ventilator, an object covering the nose and mouth that helps you to breathe when you are in a place that is full of smoke or gas
RDS
Respiratory Distress Syndrome (RDS) — Illness most commonly seen in preemies when the tiny air sacs in the lungs collapse when the baby exhales. It is caused by a lack of lung surfactant.
Retracting
When an infant breathes hard and tugs in at the chest
RFID
Radio-frequency identification (RFID) is an automatic identification method, relying on storing and remotely retrieving data using devices called RFID tags or transponders
Risk
The combination of the probability of occurrence of harm and the severity of that harm
RMM
Rapid Microbiological Methods
Room Air
Normal air we breathe, containing 21 percent oxygen
RUO
Research Use Only, a term used to indicate that a medical device product or instrument does not have an intended medical purpose and instead is to be used for research purposes only
S
SAD
Supraglottic Airway Device
SAEN
Serious adverse events are critical device-related adverse incidents. These can be classified as cases of device malfunction, deterioration in device performance, inadequate instructions or labeling that may or may not result in death or serious injury, or may lead to death or serious deterioration in state of health of the patient
SaMD
Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan – FDA driven
SE
Substantial Equivalence is a regulatory requirement by FDA for market clearance of new products through a 510(k) premarket submission
Seldinger technique
Percutaneous technique for the introduction of catheters and tubes. It avoids the need for a cutdown and employs the use of a guide wire
Sepsis
Infection
Sequential testing
Sequential testing is often required on separate but contiguous components, residual buildup of clinging tracer gases can cause problems during subsequent tests
Shunt
A small tube placed in your body to carry blood or fluid from one place to another
Sodium
One of the body’s electrolytes
SOP
Standard Operating Procedure
SD
Spray drying (SD)
Spaghetti Line
Sometimes called a PICC line or a peripherally inserted central catheter. A very thin intravenous (IV) central line, usually placed in the arm or leg
SvO2
SvO2 mixed venous oxygen saturation
Suction
Suction machines and Basic Suction Pumps are used during and after surgery to remove surgical fluids, tissue (including bones), gases and bodily fluids.
Sině
s̅–abbreviation for “without” (from the Latin preposition sině)
STED
Summary TEchnical Document
STeP
Safer Technologies Program – FDA guidance
STEMI
means that one of the coronary arteries supplying the heart is completely blocked.
SE
Substantial Equivalence, or SE, is a regulatory requirement by the FDA for market clearance of new products through a 510(k) premarket submission – a company must prove its device is as safe and effective as a similar predicate device. SE is required for regulatory submissions for which a premarket approval (PMA) is not required
Sterile / Microbial barrier
Purported loc on container beyond which no microorganism can pass under conditions qualified for the barrier
SUDS
Single-Use Devices are disposable devices intended to be used for a singular event or procedure for one patient only
Surfactant
Fluid in the lungs helps to keep them open and expanded
SVP
Small Volume Parenteral (SVP) bags, glass, or plastic ampoules
Syringe Testing
The opening may be fitted with a needle, nozzle, or tubing to direct flow in and out of the syringe barrel. It is essential that the tip of the syringe flows material through the barrel properly and that the nozzle, tubing, and the plunger’s seal do not leak. Testing types = leak test a Luer lock, normal slip tip, catheter tip, eccentric tip, or an insulin syringe
T
TAH
An implantable device that replaces both the right and left ventricles, as well as the four heart valves, and occupies the space of the removed, failing human heart
Thoratec
Type of ventricular assist device
TACCP
Threat Assessment Critical Control Points
TPR
Test Protocol
Trachea
Windpipe
Tracheostomy
A small opening in the lower part of the trachea and neck allows a tube to be passed so an obstruction can be overcome
U
UPC
Universal product code (UPC) – the product identifier used to identify an item sold at retail in the United States
UDI
Unique Device Identification, or UDI, is a system established by the FDA to catalog and identify each individual device for sale in the U.S. market by assigning a custom identifier that can be read by both humans and machines. A UDI is distinct from a Universal Product Code (UPC), as the UDI is used to identify a medical device on the FDA website via the AccessGUDID portal
UPC
A Universal Product Code, or UPC, is a code printed on retail packaging consisting of a barcode and a 12-digit number
Umbilical Artery Catheter
A small plastic tube or catheter inserted into one of the arteries so blood can be taken from the baby and intravenous (IV) fluid and medications can be given to the baby
URP
Uniform Recall Procedure
Urinalysis
Laboratory examination of urine
URS
User Requirement Specification
USP
United States Pharmacopeia
V
Vaso
vasodilator (vaso/ dilator) – causes the dilation/relaxation of a blood vessel
VAERS
Vaccine Adverse Event Reporting System
VAC
Vacuum-assisted closure of a wound is a type of therapy to help wounds heal
Validation
The process involving the identification and control of materials and processing variables that affect the ability of a packaged device to meet its acceptance requirements
Vein
A blood vessel that carries unoxygenated blood from the body back to the heart
Ventilator
Respirator
Verification
Confirmation, through the provision of objective evidence, that specified requirements have been fulfilled
V and V Verification and Validation, also known as V&V
activities for testing and confirming whether a medical device meets the design procedures and is ready to be released for manufacture
Volumetric
Volumetric pumps deliver large amounts of medication using more advanced features
VACCP
Vulnerable Assessment and Critical Control Point
W
WHO
World Health Organization
WNL
Within normal limits
WYSIWYG
What you see is what you get
Work-up
Work-up (Septic) – A series of tests to identify the organism causing infection – It is done before starting on antibiotics. The tests may include a complete blood count, blood and urine cultures, and a lumbar puncture
Misc.
21 CFR PART 11
acceptance criteria by FDA of electronic records, electronic signatures, and handwritten signatures executed to electronic documents
Design Control Guidance
Design Control Guidance for Medical Device Manufacturers Text related to FDA 21 CFR 820.30
FDA Form 483
An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts
510(K)
A 510(K) is a premarket submission made to the FDA to demonstrate that a device to be marketed is as safe and effective as another legally marketed device that is not subject to premarket approval (PMA)
ISO 27001
ISO 27001 contains tools that can help assess and manage cybersecurity risks in an organization with med dev
ISO 13485
Management system for the design and manufacture of medical devices
ISO 14971
risk management system for medical devices which determine safety during the product life cycle
ISO 15189:2012
Medical Laboratories – Particular Requirements for Quality and Competence
ISO 15378:2017
Quality Management Systems – Primary Packaging Materials for Medicinal Products – Particular Requirements for the Application of ISO
ISO 5000
This standard complements ISO 14001 by offering a specific standardized system for energy management. With it, medical device manufacturers can reduce their operating expenses and improve their overall energy efficiency, which can subsequently enhance their reputation and facilitate regulatory compliance
ISO 16142-1:2016
Medical Devices – Recognized essential principles of safety and performance of medical devices
ISO/TS 20993:2006
Biological Evaluation of Medical Devices – Guidance on a Risk Management Process
ISO 9001
Requirements for quality management systems
IEC 60601
IEC 60601 is a standard pertaining to electrical medical equipment. Any medical device containing electronics must pass the necessary requirements outlined in IEC 60601
IEC 62304
IEC 62304 is a software framework that outlines software engineering and documentation practices. It is also recognized by FDA and provides a risk-based framework that can be used throughout the entire medical device software lifecycle
IEC 62366
IEC 62366 – Application of usability engineering to medical device
OHSAS 18001 / ISO 4500
Pharmaceutical and medical device manufacturing often presents specific occupational risks, particularly when working with the advanced technology found in imaging equipment and other products
Programmable Electrical Medical System
Programmable Electrical Medical Systems, or PEMS, is a key part of what is covered in IEC 60601. PEMS consists of software, firmware, and equipment that can be programmed to carry out functions that aid medical care or treatment. The standard also covers mechanical safety, labeling, and risk management
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