Post-market surveillance (PMS) has become a necessary requirement in the medical device industry in today’s interconnected global environment, where technology plays a crucial role in healthcare. PMS may come with additional costs and procedures, but it is essential to ensure safety, effectiveness, and privacy for consumers.
Safety and effectiveness for consumers
One of the main reasons for implementing PMS is the need to ensure the safety and effectiveness of medical devices. Products must not only be safe but also deliver expected outcomes. Regulatory organizations must guarantee that devices available in the market are both safe and effective, eliminating the possibility of ineffective or hazardous products for consumers.
Imposing greater responsibility on manufacturers
Before the introduction of new regulations, the responsibility for the cybersecurity of medical devices largely fell on consumers or end-users. However, it is increasingly recognized that cybersecurity is a collective task. Manufacturers have a significant role to play in ensuring the cybersecurity of medical devices throughout their lifecycle. The change in regulations aims to increase manufacturers’ accountability for device safety.
The need for post-market surveillance: real-life examples
To emphasize the importance of post-market surveillance, let’s look at a few cases that highlight the necessity for continuous monitoring and assessment of medical devices.
Hackable pacemakers
In 2017, nearly half a million implantable pacemakers were recalled from the market due to their vulnerability to cyberattacks. They allowed hackers remote access to the devices, which could lead to battery depletion or even the delivery of unnecessary electrical shocks. Although no cases of exploitation by hackers were reported, this incident definitely underscored the urgent need for constant attention to the security of implantable medical devices throughout their lifecycle.
Excessive availability of medical device-related information
Privacy concerns are another significant issue related to medical devices. In 2018, it was revealed that fitness device applications, such as Fitbit, accidentally disclosed the location and activity of US soldiers. Although this incident was not directly related to medical devices, it demonstrates the importance of proper data management. Mishandling of data can lead to privacy breaches and data theft, highlighting the necessity for effective post-market surveillance.
Infusion pump defects
Another recent incident involved the issuance of a recall classification for several insulin pumps due to a defect that prevented the detection of air in the tubing. The presence of air in the pump can have life-threatening consequences, such as asphyxiation or blood vessel blockages. Although no serious health threats have been reported so far, this incident emphasizes the significance of post-market surveillance in quickly identifying and removing faulty devices.
Post-market surveillance should be seen as an integral part of conducting business in the medical device industry. It not only ensures regulatory compliance but also promotes the safety, effectiveness, and privacy of consumers. Through active monitoring and assessment of devices after their market introduction, we can identify potential risks and prevent harm to patients.
Frequently Asked Questions (FAQ)
What is post-market surveillance?
Post-market surveillance (PMS) is the process of continuously monitoring medical devices after their introduction to the market to ensure safety, effectiveness, and compliance with regulations.
What are the benefits of post-market surveillance for consumers?
Post-market surveillance provides consumers with safety and effectiveness assurance for medical devices and protects their privacy.
What are some examples of incidents that highlight the importance of post-market surveillance?
Examples include the recall of hackable pacemakers, inappropriate disclosure of information by fitness device applications, and defects in infusion pumps.
Sources:
– Sample Website
– Another Sample Website
The source of the article is from the blog qhubo.com.ni