Medical devices play a crucial role in diagnosis, treatment, and rehabilitation of disease and illness. According to estimates, over 50,000 medical devices are in use daily in healthcare divisions all over the world. Some of them are simple, while others are quite complex and combine more than one technology.
A critical resource in the healthcare ecosystem
There is no doubt that medical devices are tangible assets and need to be appropriately maintained. They require a lot of investment and maintenance costs, as they have a direct effect on human lives. The world health organization’s (WHO) report states that over 50 to 80% of the medical equipment in developing countries are non-functional, not used correctly, and are not well maintained. Therefore, in many cases, they fail to deliver the desired healthcare service. Unless hospitals have a proper policy in place for the management of medical devices, it isn’t easy to correct the situation.
This problem is further compounded by the fact that most hospitals fail to utilize the full potential of technology that is currently available. The depreciation value of medical devices from procurement to use is highly non-typical. According to estimates, on an average, 30% of depreciation occurs because of incorrect specifications, irrational use, shortage of spare parts, lack of inspection and preventive maintenance, and repair agreements with the supplier. Owing to all these factors, the value of a device falls to about a tenth of the original investment.
Accurate documentation of device failures
Another dimension to the problem is the lack of accurate repository and documentation of device failure. Healthcare providers fail to monitor the performance of medical devices and report issues in time. Even injuries caused by device malfunctions are not recorded properly, and therefore unable to tell about faults caused due to network tampering.
To address the device failure issue, healthcare facilities must maintain a central repository of all the medical devices. Automated systems can be used to maintain an up to date inventory. Clinical workflows must incorporate the role of medical devices to estimate the impact of malfunctioning devices on the quality of patient care. The system must also be used to monitor device communications to identify anomalies in case of an intrusion.
What makes medical devices risky?
The Food and Drug Administration (FDA) in the United States has released countless warnings regarding the common vulnerabilities that plague medical devices. These vulnerabilities pose a threat to patient safety. The list includes not only MRI machines and CT scanners but also other medical devices like infusion pumps, ECG machines, and lab analyzers, to name a few. What complicates it further is the fact that clinical systems are increasingly connected to smart devices, which makes them prone to cyber-attacks. If hackers or people with vested interests manage to tamper with the medical devices, it endangers the lives of patients.
In a recent press note, Suzanne Schwartz, deputy director – Strategic Partnerships and Technology Innovation in the FDA’s Center for Devices and Radiological Health says, “Medical devices are becoming increasingly connected, and connected devices have inherent risks, which make them vulnerable to security breaches. These breaches potentially impact the safety and effectiveness of the device and, if not remedied, may lead to patient harm.”
Schwartz further adds, “The FDA recommends that medical device manufacturers stay alert for cyber security vulnerabilities and proactively address them by participating in coordinated disclosure of vulnerabilities as well as offering mitigation strategies. An essential part of the FDA’s strategy is working with manufacturers, health care delivery organizations, security researchers, other government agencies, and patients to address cyber security concerns that affect medical devices to keep patients safe.”
As a critical component of clinical and support technologies in the healthcare ecosystem, medical devices must be managed and used properly to produce effective medical intervention. Healthcare providers are gradually becoming aware of the need to secure medical devices. Once we establish transparent systems and methods for analyzing device failures, only then will we be able to have a full idea of the risks involved. Moreover, with better visibility and control over the functional aspects of medical devices, healthcare facilities will be able to safeguard their patients better and ensure continuity of quality treatment.
Author – Nikhilesh Tiwari, founder of Collateral Medical (Colmed). Colmed is India’s leading medical device, instruments, consumables and disposables marketing and distribution company in India.