Every industry has its own lingo. Yet, among all profession-specific languages, one of the pillars of med tech is surely the use of acronyms. As a bit of trivia for your next industry conversation, the use of acronyms evolved out of telegraph code, where creative abbreviations for words were born to save time (and money, if you were the sender).
ASL Note: Not to be confused with ASL, as in American Sign Language
BOM Note: Not to be confused with slang expression of admiration, “You’re da BOM(B)!”
CA (1st meaning)
CA (2nd meaning) Note: Because the best acronyms are obviously worth using more than once, with entirely unrelated meanings. Also, not to be confused with yet another use of CA, the State of California abbreviation.
CAPA Note: Not to be confused with urban slang “cappa,” or someone who cannot tolerate much alcohol (he could only handle a ‘cap’ full, or “cappa”). Also,see item 6., not applied.
cGMP Note: Because why not throw in a lower-case letter?
DC Note: Not to be confused with the geographic location of US political headquarters.
EtO Note: Not to be confused with famed Cameroonian soccer player, Samuel Eto’o!
HDPE Note: Finally, an acronym that stands alone.
IFU
RA 1
RA 2 See Note for items 3 and 4 above. Also, not to be confused with the ancient Egyptian sun deity, “Ra” whose mother lived before the 19th century advent of acronyms.
SOP Note: Not to be confused with similar “SOS” call for help, or its obsolete word form, “sop,” meaning to soak.
UDI Note: Not to be confused with US gluten-free baked goods brand (yum!).
V&V
CHEAT SHEET
ASL Approved Supplier List, maintained by medical device and packaging manufacturers to denote suppliers known to meet or exceed the manufacturer’s quality practices.
BOM. Bill of Materials, a complete inventory of ingredients, materials and components compiled by design teams and manufacturers of medical devices or pharmaceutical companies to exhaustively indicate volume and specifications for everything needed to produce the finished product. Also used to track and implement change management.
CAPA. Corrective and Preventive Action, A formal US Food and Drug Administration process by which a medical device maker implements changes to processes or quality steps to mitigate or remove risks or non-compliant factors.
CA. Conformity Assessment, European Union regulatory documentation confirming that a medical device has passed safety and intended use requirements.
CA. Competent Authority, a legislative body within each European Union member state.
cGMP. Current Good Manufacturing Practice, the body of US FDA regulations by which pharmaceuticals are deemed compliant (or non-compliant) across packaging, manufacturing and processing of a drug.
DC. Design Controls, the FDA’s process under 21 CFR 820.30 that outlines design requirements and documentation processes and procedures throughout the medical device process, including the packaging, to ensure regulatory compliance.
EtO. Ethylene Oxide, a common, low temperature gas used in medical device sterilization. It is widely used for healthcare product sterilization due to low moisture and heat considerations for medical device materials and packaging.
HDPE. High Density Polyethylene, growing in use throughout the industry and the most environmentally stable of all plastics (no environmentally harmful emissions). The material is also energy efficient to produce. It can be made into many forms, making it ideal for medical packaging and containers.
IFU. Instructions for use, the print literature and “form of prescription drug labeling.” Content is required to be inserted in packaging of all drugs and certain classes of medical devices to meet EU and US FDA regulatory requirements.
RA. Regulatory Affairs, a team within most pharma companies dedicated to and responsible for the approval and regulatory process for both drug and medical device design and manufacture.
RA. Risk Analysis, the methodologies used to identify risks within processes, procedures, and medical device design that exist on the production continuum. Analyses associated with RA include fault tree, preliminary hazard or failure mode and effect, for example.
SOP, Standard Operating Procedure, an organizational procedure that sets forth repeatable, standardized actions to be followed. The SOP provides written documentation to ensure that employees and teams act and implement work in support of the Quality Management System.
UDI, Unique Device Identification, Evolving, multifaceted FDA labeling requirements. The UDI concept was first presented as a 2013 Rule that “[established] a system to adequately identify devices through distribution and use.” With myriad global and practical considerations, UDI rules, non-binding guidance and related FDA database (Another acronym! See, GUDID), continue to take shape.
V&V, Validation and Verification, this encompasses all the actions implemented by design teams to test and confirm that medical device design procedures have been met. Analysis and testing determine the readiness of the product for manufacturing.