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Medical device recalls are inevitable – can your systems locate every patient affected?

Medical device and implant recalls are an unfortunate reality.

When they happen, hospitals need to spring into action, identifying all affected patients and taking the recommended precautions.

But all too often medical data is incomplete.

And former patients will be walking around completely unaware of a potentially ticking timebomb.

So how can hospitals ensure 100% of medical devices and implants are captured at the point of use?

 

UDI medical device and implant recalls.
UDI medical device and implant recalls.

Getting implant tracking workflows right

The FDA publishes and circulates recalled UDI medical devices so that manufacturers, distributors and hospitals can take the appropriate action with expired medical supplies. Their priority will be to protect patients who have consumed the device and remove recalled products from circulation.

Hospitals need to have robust workflows in place on two fronts in order to protect patient safety and safeguard hospital compliance:

  1. Proactive: to digitally record of all medical devices and implants used during surgery
  2. Reactive: to quickly identify and contact the group of patients who consumed a recalled item, as well as to locate and remove recalled stock items.

 

Both of these activities rely upon one thing.

Accurate data.

 

  • Where are the stock items that need to be immediately removed from supplies cabinets?
  • Which patients had the specific batch of the item that has been recalled?

 

Let’s look at both of these in turn.

Gaining full visibility of medical device and implant inventory

Today most hospitals have some type of medical device, tissue and implant cabinet. Many of these will use RFID technology to provide smart management of this high value stock. RFID cabinets use sensors to track the items stored and removed from the cabinet, giving full visibility of the stock at hand. When a product recall occurs the hospital has full inventory visibility and is therefore able to identify recalled items that need to be removed.

IDENTI’s TotalSense cabinet not only provides full inventory vision but it’s AI management software will provide a report on all recalled products that are in the system, allowing for quick action to be taken before a single item is accidentally used.

While undoubtedly a great resource, smart medical device cabinets have their limitations. They are great at managing consumable items but do not associate the items removed with individual patients.  This is the responsibility of the perioperative nurse at the point of care.

Digital documentation of every implant, consumable or medical device during surgery

FDA UDI Regulations dictate that all consumable UDI devices and implants need to be logged at patient level, so that there is a full, digital record that associates the implant with the patient.

In short, every single implant that is consumed needs to be treated as a potential recall and be digitally documented on the EHR.

This patient and batch tracking is where the system can fail. Let’s look at why.

Reasons that medical device and implant usage is not fully captured during surgery

There are many reasons that all items consumed during surgery are not digitally recorded, here are some of them:

Perioperative nurses are busy and the patient is their primary focus; if recording the item is not simple then it will likely join a pile of uncaptured packaging in the procedure room – which is unlikely to end up recorded on hospital systems.

How to record 100% of consumables during surgery

There IS an easy way to record medical devices and implants in OR and it just takes 3 seconds!

Snap & Go by IDENTI Medical is a groundbreaking item capture tool designed for the surgery setting.

Using patent-protected image-capture technology, this award-winning tool digitally captures all product information – whether the item is on the master list or not. Even if it is trunk stock.

It also gives a real time warning if the item is expired or recalled, giving perioperative nurses a safety net that prevents ‘never events’.

Snap & Go image recognition
Snap & Go

100% data capture = recall-friendly workflows

Snap & Go fills in the data gaps in your operating spaces. It provides a digital link between patients and products and prevents the usage of unsafe, recalled medical devices and implants.

It puts an end to time-consuming and inaccurate manual recall checks by seamlessly integrating a quick, effective data capture solution into clinical workflows at the point of care. The result is the ability to carry out prompt recall identification, providing a layer of protection for patients and ensuring full hospital compliance.

Contact us for a demo.

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