Information Transparency Challenges

Surgery team operating in a surgical room

Millions of medical devices are in use around the world today, ranging from latex gloves, hospital beds, and syringes to stents, pacemakers, insulin pumps, replacement knees, and hips. These devices are often treated before use to ensure strength and durability. Para Tech Coating provides parylene biocompatible coatings for medical devices, and this and other steps helps those devices save lives, reduce pain and suffering and improve the quality of life for patients.

However, complications or malfunctions can have severe consequences, including death, injury, or pain and suffering for patients. These problems, termed “adverse events” by the FDA, could be caused by improper application of the device or user error, improper or poor labeling, device malfunction, or faulty manufacturing. If it’s suspected that there is a problem with a device, it should be fixed immediately instead of being ignored; it could put someone’s life in potential danger. Sometimes, the issue could be resolved by simply contacting a medical cable assembly manufacturer instead of a whole replacement of equipment.

Ultimately, there is no denying that safety has to come first when working in a medical setting. With this in mind, it is vital that measures are put in place to protect patients, doctors, nurses, and other medical facility staff from hazards and danger. For example, it is no secret that medical facilities are often home to large amounts of hazardous chemicals. Put simply, when organizations like medical facilities and laboratories store or handle chemicals within their workplace, some spillage is inevitable. Therefore it is essential to have a spill response plan in place. With this in mind, it is crucial that staff have access to emergency cleaning equipment such as these Storemasta Spill Kits. Above all, investing in spill kits ensures that any spills can be combatted safely and efficiently.

Need for Clear Actionable Information

Healthcare organizations are routinely challenged by the inability to quickly access up-to-date medical device adverse event information. When the right information is available, they can make informed decisions that will ultimately save lives, improve patient outcomes, mitigate risk, and save money.

Many in the healthcare community believe the US FDA identifies all problem medical devices quickly and keeps the healthcare community informed through recalls and notifications. Over 70,000 medical device adverse events are reported every month, but it can take the FDA between two months and two years before problem devices are identified. Once identified, further analysis is required and, if deemed appropriate, the FDA will issue a recall notification to the device manufacturer. The manufacturers should be able to recall these devices easily. When devices like this are being produced, most manufacturers will make sure to print an individual code onto each product with a continuous inkjet printer. This helps them to track the products if the devices become faulty. These printers are being used in more manufacturing plants recently as some of them are now able to print on top of darker colors, ensuring that these codes are visibile on any product or device. To read more about these printers, people could visit a German Site called Kunststoffweb, for example.

The FDA provides public access to over 5.9 million redacted, HIPAA compliant, medical device adverse event reports (MDRs) through their Manufacturer and User Facility Device Experience (MAUDE) public website. However, extracting meaningful information and metrics is cumbersome and requires a great deal of time and effort.

Example FDA MAUDE Data

Consequently, healthcare organizations may not have or be able to access all the pertinent information they need in a reasonable time-frame. Without it, they lack the information for optimal device selection and use – putting patients, physicians and their organizations at risk.

Metrics on Adverse Events and Recalls – Difficult to Obtain

Additionally, MDRs are often misclassified and use ambiguous, confusing language making it virtually impossible, using the FDA’s MAUDE website, to access and obtain accurate and complete metrics on all the MDRs submitted for a device.

For example – When an MDR is submitted by a device manufacturer, a healthcare organization or a patient/patient advocate, they must classify the event as either a Death, Injury or Malfunction. Many reports are classified as Injury or Malfunction even though a Death occurred, obfuscating the true result of the event.

Adverse Event and Recall Information Transparency

Device Events provides easy access to clear, comprehensive metrics, reports and signal alerts on a medical device’s adverse event history. As a result, users are empowered with the most comprehensive and up-to-date information enabling them to act decisively to reduce risk for all concerned parties.

CLICK HERE to view a demonstration of Device Events