Tag Archives: Food Drug and Administration

How medical device surveillance benefits clinicians

Patients deserve high-quality care options, thoroughly grounded in research to ensure the best possible outcomes. It sounds like an obvious staple of the health-care world, but this is not always the case.

Efforts exist to better understand the effects of prescription drugs – both benefits and risks – but no such efforts exist to discover the same in medical devices. In fact, many devices have little accompanying data pertaining to their effectiveness, reliability or quality once they are released to the market. Instead, these things are learned “in the field” when they are used in association with the treatment of patients. Rarely is that information shared.

This isn’t to say clinical trials are not done – far from it in fact. But the information these trials offer often fails to answer the questions that arise from in-practice situations.

Medical professionals are working to change this. A joint project from the Center for Health Policy at Brookings, the Food and Drug Administration and clinician, industry, payer and patient representatives will seek to outline the process for creating a national system that captures important device-related information as they are used in the field.

The medical device post market surveillance system, as it is being called, aims to improve safety surveillance while supporting device evaluation capabilities. The data gleaned here will further allow clinicians to analyze the device’s capabilities, overall quality and how it compares to other devices in the same space.

To succeed, however, the system will need to determine how to gather this information while minimizing the reporting required from clinicians. Research shows the average clinician may spend as little as four minutes with a patient, and most spend 8-15 minutes reporting afterward. It is not possible for these numbers to actually decrease if additional reporting time is required.

This new evidence must also be delivered in real time in order to offer any benefit. In a fast-paced industry such as health care, data that is reported late will likely be reported for a device that has already become obsolete.

While these are important challenges, the idea of a medical device post market surveillance system offers benefits to everyone involved in health care. Patients deserve high-quality options and such a system makes those options possible.

To find the medical devices your health-care facility needs, visit MedicalDeviceDepot.com.

How patient experience improves the medical device industry

This is an exciting time to work in the medical device industry. After decades of trying to determine the role of patient experience when creating regulatory policy, it appears answers may finally be coming.

The Medical Device Innovation Consortium released what it calls an “initial thought piece” in May, providing a guide for device makers seeking out information regarding patient preference when submitting data to obtain product approvals. The Consortium represents a joint effort of the device industry itself, the National Institute of Health and the Food and Drug Administration.

Ross Jaffe of Versant Ventures says that while patient preference is not required for a device manufacturer to obtain FDA approval, device manufacturers should consider it “an enhancement of a submission.”

In addition, device manufacturers benefit from the newly released FDA guidance that outlines just what patient preference information will be reviewed and considered by the FDA when weighing approval of any application for a new medical device.

For medical device manufacturers, these developments shed new light on an area that has always been frustratingly unclear. Device manufacturers can now use this information and these new guidelines to efficiently deliver proper applications to the FDA and get new, helpful medical devices on the market for the health-care facilities and patients in need, all more quickly than ever before.

To find all of the medical devices your health-care facility needs, contact Medical Device Depot today

Medical device recall numbers plummet in first quarter

The year 2015 is off to a great start in the medical device industry, with medical device recalls falling to near-record lows in Q1. That’s according to a review of the Food and Drug Administration’s (FDA) data conducted by Regulatory Focus.

Reviewing the FDA’s data shows that while 968 separate device recall events took place in the fourth quarter of 2014, only 426 recalls took place in the first quarter of 2015. This figure marks the lowest recall total since Q1 of 2013 when 367 recall events took place.

So why the big change between Q4 of 2014 and Q1 of 2015?

According to the Regulatory Affairs Professional Society (RAPS) three large incidents involving more than 721 recalled devices took place in 2014, making recall numbers especially high. In one instance, 233 devices were recalled because of packaging flaws. Even though the supplier and customer were the same for each device, it still counted as 233 recalls. The first quarter of 2015 represents a shift away from these previous outliers and a lower, more positive recall number.

It’s also important to point out that the recall numbers show only the number of different models recalled, not the total number of devices recalled. Some recalls may affect 10 or fewer devices while others can affect thousands or even millions. Each case is treated as one recall incident. It’s also worth noting that the FDA’s entrance of a recall reflects the date the FDA classified the recall, not the date when the recall actually occurred.

After recalls peaked at the end of 2014, a recall reduction of more than 50 percent last quarter is a great way to start the New Year. History shows recall numbers have fluctuated in Q2, being both higher or lower than their Q1 counterparts in 2013 and 2014. As the industry moves forward, it would prefer the latter.