Article by Richard Asiedu Ofori, Msc, MBA, CQP, MCQI ; Head of Industrial Metrology, Quality Coordinator, Metrology Directorate -Ghana Standards Authority
Verification is an activity to confirm if a measuring device is within specified requirements as stated by law. In other words, verification is intended to check that a product, service or system meets a set of requirements, specification and regulation. It is a process that is used to evaluate whether a product, service, or system complies with regulations and specifications. What is a medical device? A medical device is an instrument which is used for medical purposes in patients, in diagnosis, therapy or surgery if applied to the body. This article is centered on blood pressure medical device. Blood pressure is the pressure in the arterial system of the body. If your blood pressure is too high over a period of time, and is not treated, you are more likely to have a stroke, heart attack, or kidney failure in the future.
There is also increasing evidence that high blood pressure is linked to dementia a state of heart disease, organ damage and early mortality. High blood pressure usually has no signs and symptoms, which is why many people do not know they have it. For this reason it is often called the silent killer. The only way to find out whether one has high blood pressure is to have it measured correctly. This explains why it is important to have blood pressure devices checked and verified regularly. Measurement of a patient’s blood pressure is one of the most important medical assessments. However, errors in measuring blood pressure occur often. Most errors result in overestimation of blood pressure, which in effect is a cause of wrong diagnosis of patients as being hypertensive. Unverified and inadequately verified medical instruments are an unrecognized cause of preventable medical errors.
This article also focuses on the needs for the health sector to promote safe use of sphygmomanometers for the diagnosis of patients. It also identifies factors contributing to errors during measurement of blood pressure and assesses the precision and integrity of all sphygmomanometers. Sphygmomanometers that measure patient’s blood pressure inaccurately could cause wrong diagnosis of patients as being hypertensive. It also provides information and guidance to all involved with the purchase, management and use of blood pressure measurement devices.
A system for ensuring that medical measurement systems are traceable would improve the quality of health care and reduce overall costs to patients and the society in the long term. All blood pressure measuring devices require regular verification. Verification of devices subjected to intensive usage should be repeated at regular intervals. Information should be clearly provided on the need for periodic verification of medical devices. The measurement of blood pressure is important in the diagnosis and monitoring of a wide range of clinical conditions. Physicians agree that daily self-monitoring of blood pressure is an important step individuals can take to maintain cardiovascular health and prevent the serious consequences associated with undetected and untreated hypertension. Failure to identify hypertension is largely due to the unavailability of
suitable blood pressure measurement devices and the limited attention paid to the techniques and procedures necessary to obtain accurate blood pressure readings.
Accuracy is of prime importance when selecting a blood pressure measuring device. Thus, regardless of the type of device used, standardized validation procedures are essential (OIML R16-1), (OIML R16-2). In this regard it is important to define standards and refine specifications to be sent to industries, as well as to provide information to assist consumers in selecting reliable devices. The use of sphygmomanometers should go beyond government white papers and policy formulation into more practical approach of educating society, schools on the benefits of blood pressure measurement.
It is important that health professionals in collaboration with industry should explore the development of precise and accurate blood pressure measuring devices for the health industry.
Accuracy is of prime importance when selecting a blood pressure measuring device and it is necessary to standardized validation procedures. In this regard it is important to define standards and refine specifications to be sent to industries, as well as to provide information to assist consumers in selecting reliable devices.