On February 6, 2018, the China Food and Drug Administration (CFDA) and its Center for Medical Device Evaluation (CMDE) issued a draft guidance entitled “Guidance on the Review of Medical Devices for Preventing and Treating Rare Diseases.” The draft guidance is based on the reform measures recently outlined in the government’s broad blueprint for drug and device reform—the Opinion on Strengthening the Reform of the Drug and Medical Device Review and Approval Process to Encourage Drug and Medical Device Innovation (“Opinion 42”).
It is a disturbing, but true fact that medical devices are hacked. Medical devices have inbuilt software, and hackers try to breach this. Medical device cybersecurity is thus critical, because lack of it can bring harm to patients who use medical devices that come with software built into them.
When the FDA identifies that a product it regulates violates the law, it protects the public by working with the manufacturer and distributors to facilitate the product’s recall (i.e., removal from the marketplace or product correction). Among other actions, FDA assures that the public is warned when products present the most significant public hazards, including those recalls associated with an outbreak.
Recent guidance from UK medical device market regulators on human factors engineering (HFE) includes some recommendations that differ from HFE requirements established in Europe, suggesting a more standalone British approach to some areas of device development.
A study released in October 2017 found EHR (electronic health records) use has been listed as a contributing factor to patient injury at an increased rate over the past decade. Poorly-designed EHR systems combined with human error have resulted in patient safety problems in an increasing number of malpractice claims from 2007-2016.
The final FDA guidance on design consideration and pre-market submission for interoperable medical devices was released on September 6. The demand for these devices is increasing in the healthcare system as our dependence on more rapid and protected interactions between devices grows. This increase presents a need for a parallel increase in adequate FDA regulations for this elaborate device field.
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