Reducing cardiovascular complications by standardization

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Reducing cardiovascular complications by standardization


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It’s no surprise that the ageing population is changing healthcare needs. There is already an increase in surgery on the elderly and with the improving life expectancy this will continue to increase.

Currently, the main cause of death in the UK is cancer. In the past heart disease has been the highest but according to The British Heart Foundation there has been a 74% decline in the deaths by a cardiovascular disease since 1969. This now places cardiovascular disease as the second leading cause with 28% of all deaths. Dying from a heart condition is more common among men, while among women above 80 there is a higher mortality rate by dementia or Alzheimer’s. Therefore, we can expect research to remain focused on treating cardiovascular diseases. 

In the UK cardiovascular disease remains the second leading cause of death, with 28% of all deaths.

A good example of a possible surgical procedure is a heart valve replacement. This surgery is performed when one or more valves are damaged. As the diseased valve will affect the blood flow this surgery can improve the patient’s quality of life. There are a number of different types of replacement valves available on the market. The most common options are a mechanical valve or a tissue valve. The tissue valves are made with cardiac tissue from porcine or bovine. Considering that tissue heart valves don’t need lifelong anticoagulant medication, it is particularly recommended for patients above 65. The downside of the tissue valve is that it has a limited lifespan between 10 and 15 years. There are also a number of complications that can occur during or after the surgery. One example is a bacterial contamination which can occur during a number of phases of the surgery. This can occur at the moment of organ harvesting to the storage or transport, or even by surface contact. This contamination can lead to prosthetic valvular endocarditis (PVE), which in some cases can lead to death.  

Yearly an estimate of 280,000 people undergo aortic valve replacement globally

The lifespan of the biological valve is typically 10 to 15 years

Bacterial contamination can occur during any phase of the surgery. This infection can lead to prosthetic valvular endocarditis (PVE), which in some cases can lead to death. 

PVE develops in 2-3% of patients within the year of the valve replacement. Early-onset infections are mainly caused by contamination during surgery.

Luckily research has established methods to reduce the likelihood of these complications occurring. Standards play a part in this, by generating European or even international standards we can create a standard practise to protect patients and medical staff. These guidelines can define processes such as animal tissue harvesting, sterilization, risk assessment and many more important factors.

To mitigate the risks, standards define processes such as animal tissue harvesting, sterilization, risk assessment and more.

BSI publishes these standards to protect the patients and surgical staff. Currently, 400+ harmonized medical devices standards exist.

Sometimes the European Commission even mandates the creation of a new standard to address a particular risk or to ensure that quality controls are at hand and used by healthcare facilities in Europe.

Some examples of standards that could be applicable when dealing with valve transplantation:

  • BS EN ISO 22442 series for risk assessment of medical devices with an animal origin
  • BS EN ISO 14160 for liquid chemical sterilization of single use products
  • BS EN ISO 5840-2 for performance requirements for surgical heart valve substitutes 
  • BS EN ISO 10993-2 for animal welfare requirements in biological evaluations

There are also standards that cover a wider quality such as, BS EN ISO 13485:2016 which specifies requirements for  medical devices which need to meet customer and applicable regulatory criteria  in different global regulatory jurisdictions. It ensures a consistent design, production, installation, and delivery of devices safe for their purpose. Or BS ISO 18362: 2016 that it was specifically designed to help with the prevention of ingress of extrinsic contamination during processing, and also describes processes to minimize the risk of intrinsic contamination growth.





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ISO 13485

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