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 ïŹts 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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