PA.NET International Quality Certification Protocol for blood pressure monitors.
Although standard validation protocols provide assurance of the accuracy of blood pressure monitors (BPMs), there is no guidance for the consumer as to the overall quality of a device. The PA.NET International Quality Certification Protocol, developed by the Association for Research and Development of Biomedical Technologies and for Continuing Medical Education (ARSMED), a nonprofit organization, with the support of the Italian Society of Hypertension-Italian Hypertension League, and the dabl Educational Trust denotes additional criteria of quality for BPMs that fulfilled basic validation criteria, published in full in peer-reviewed medical journals. The certification is characterized by three phases: (i) to determine that the device fulfilled standard validation criteria; (ii) to determine the technical and functional characteristics of the device (e.g. operativity, display dimension, accessory functions, memory availability, etc.) and (iii) to determine the commercial characteristics (e.g. price-quality ratio, after-sale service, guarantee, etc.). At the end of the certification process, ARSMED attributes a quality index to the device, based on a scale ranging from 1 to 100, and a quality seal with four different grades (bronze, silver, gold and diamond) according to the achieved score. The seal is identified by a unique alphanumeric code. The quality seal may be used on the packaging of the appliance or in advertising. A quality certification is released to the manufacturer and published on www.pressionearteriosa.net and www.dableducational.org. The PA.NET International Quality Certification Protocol represents the first attempt to provide health care personnel and consumers with an independent and objective assessment of BPMs based on their quality.
Omboni
Stefano
S
ARSMED (Association for Research and Development of Biomedical Technologies and for Continuing Medical Education), Varese, Italy. presidente@arsmed.net
Costantini
Carlo
C
Pini
Claudio
C
Bulegato
Roberto
R
Manfellotto
Dario
D
Rizzoni
Damiano
D
Palatini
Paolo
P
O'brien
Eoin
E
Parati
Gianfranco
G
D001795:Blood Pressure Determination / Q000295:instrumentation*; D002138:Calibration; D002568:Certification; D006801:Humans; D011786:Quality Control