The UDI Education Series:

How does the UDI Rule improve Medical Device Recalls?

The current state-of-the-art method for investigating a medical device recall is typically a manual process which requires the Risk Management department and other hospital staff to check current inventory and patient implant records to determine exposure of the recall within the facility. The UDI Rule will streamline this process in the following ways:

• By providing a standardized identifier, hospitals can track inventory at the production identifier level (serial number, lot number, expiration date) for the first time.
• Because of this new standardization it should become easier for healthcare professionals to capture specific implant usage data by procedure and patient.
• Utilizing internet based UDI implant tracking services, hospitals will also be able to identify recalled devices in their inventory more efficiently.

For over 2 years Champion Medical Technologies has been attending UDI conferences, workshops and educating hospitals on the UDI initiative. Our market leading UDITracker® service with RecallConnect™ was specifically designed to help hospitals keep pace with regulatory changes. We’ve been preparing for this moment so you don’t have to.

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How does the UDI Rule improve Medical Device Registries?

The current state-of-the-art method for collecting data for device registries is a manual process which requires the physician to complete a survey on their own time. As a result, data submission rates to these registries is disappointingly low.

• Because the UDI rule will standardize the labeling of medical devices, it should become easier for healthcare professionals to capture specific implant usage data by procedure and patient.
• Utilizing internet based UDI implant tracking services, physicians would be able to submit non-confidential patient and implant records directly to registries. This automates the submission process to significantly improve participation.
• Better physician participation means better outcome data and improved postmarket surveillance of medical devices.

For over 2 years Champion Medical Technologies has been attending UDI conferences, workshops and educating hospitals on the UDI initiative. Our market leading UDITracker® service was specifically designed to help hospitals keep pace with regulatory changes. We’ve been preparing for this moment so you don’t have to.

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1. What is the UDI rule?

An FDA initiative requiring most medical devices distributed in the United States to carry a unique device identifier, or UDI. Congress passed legislation in 2007 directing the FDA to develop regulations establishing a unique device identification system for medical devices. The final rule should become law by the Spring of 2013.

2. What are the benefits of a UDI system?

The UDI system has the potential to improve the quality of information in medical device adverse event reports, which will help the FDA identify product problems more quickly, better target recalls and improve patient safety.

3. How does it work?

Each medical device will be given a code that will contain two types of information: a unique numeric or alphanumeric code, called a Device Identifier, which is specific to a device model, and a Production Identifier, which includes the current production information for that specific device, such as the lot or batch number, the serial number and/or expiration date. These identifiers will be used to track medical devices from manufacturer to patient.

4. Will the UDI rule affect hospitals?

Yes. In order for the UDI system to be effective, hospitals must be involved in the tracking of these medical devices throughout their supply chain.

For over 2 years Champion Medical Technologies has been attending UDI conferences, workshops and educating hospitals on the UDI initiative. Our market leading UDITracker® service was specifically designed to help hospitals keep pace with regulatory changes. We’ve been preparing for this moment so you don’t have to.

The post The New UDI Rule – 4 Facts Every Hospital Should Know appeared first on Champion Medical Technologies.

Why should you stop tissue tracking with a log book?

Everyone who works in an OR knows all about The Joint Commission and the FDA. They are the ones that make up the rules about how we handle implantable tissue and medical devices in our facilities. Perioperative nurses are the primary advocates for their patient’s safety. We all know that the rules are evidence-based and exist for the safety and protection of our patients—however, that is not to say that sometimes following and interpreting the rules is always easy, and can contribute to a few grey hairs. Until recently, the tracking of implantable tissue and medical devices was, at best, inconsistent and incomplete.  A report  for the first half of 2010 issued by The Joint Commission showed that only 28% of hospitals surveyed were compliant in using standardized procedures for managing tissue!  Champion Medical addressed the tracking challenge and offers two products that help hospitals meet regulatory compliance. Here are five reasons for you to upgrade your old tissue logbook to GraftTracker® or UDITracker®.

1. Ensure Joint Commission Compliance

UDITracker® and GraftTracker® were designed from the ground up to meet The Joint Commission Hospital & Laboratory Accreditation tissue tracking Standards for simplified compliance. Since their implementation in hospitals around the country, our customers have not only been compliant, but honored for their peak level of performance. With UDITracker® and GraftTracker®, specifically requested reports and logs can be accessed and produced in seconds during your next site visit from The Joint Commission. Compliance has never been easier!

2. Save Time & Money

Checking out-dates is time consuming and potentially costly in terms of very expensive implantable device products lost and staff productivity. No more worrying about assigning staff to the task–UDITracker® / GraftTracker® automatically notifies you up to 90 days prior to the expiration date of your tissue and implantable devices. You’ll never again lose money due to items that expire on the shelf!

3. Speed Up Recall Investigations

Untimely manufacturer recalls coupled with the arduous task of investigating can be futile. Even using multiple staff members; the task can take weeks or months to complete, if the information is found at all. When you log into your UDITracker® / GraftTracker® program, you will find the most up-to-date recall notices from the FDA right on your desktop. In seconds, RecallConnect™ will locate all recalled items, not only in your available inventory, but will notify you of inventory that has been implanted or discarded as well.

4. Focus on Patients

Are your circulating nurses spending time out of the OR and away from their patient when searching for a particular tissue product that may not even exist in your inventory? UDITracker® / GraftTracker®‘s search capabilities allow them to search available inventory by multiple means, including product type, product code or ID/Serial/Lot number. Search results will provide the available inventory level and location in seconds.

5. Reduce Files & Paper

Hand-written forms, ledgers, spiral notebooks, temperature logs, Excel spreadsheets and supplier provided forms produce VOLUMES of paper and electronic files. UDITracker® /GraftTracker® traces every step of your implantable device inventory; from receipt to final use or disposition in one safe, easy to access format.

Don’t just take our word for it, click here to read what our customers have to say.

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