A recent Recall report from Stericycle Expert Solutions shows that 2018 Q2 results had the highest medical device recall count since 2005. The leading cause of recalls was software, while the biggest reason for recalled units was sterilization. What is causing this spike in recalls? In today’s growing healthcare industry, medical technology is expanding at an incredible rate. Amidst this growth in innovation, patient safety and positive outcomes must remain the center of attention in all aspects of the industry. While the objective of new medical technology is to decrease financial burden, increase device quality, and create better patient outcomes, the onus is on Value Analysis Committees to ensure patient safety before a product can be purchased for use.

Hospitals and physicians are trusted by their patients to have their best interest in mind; thus, it is the hospital’s duty to confirm the safety of a medical device. To do this, hospitals may utilize the FDA MAUDE database and FDA Recall database. The MAUDE database lists adverse events in which a device was involved. The events include deaths, injuries, malfunctions, or other abnormal happenings. By comparing the frequency and quantity of individual events, a hospital may assess the risk of a device. The Recall database shows current and past recalls on all medical devices, and the hospital may use this database to reference recalls.

To ensure the safety of a device, Value Analysis Committees may use the information from all sources to determine the risk associated with the device, and the likelihood that the device will harm a patient. The Value Analysis Committee is the final decision maker in the evaluation of a product, and the last line of defense for patients. The patient’s safety and care ultimately rest on the hospital’s shoulder, and the committee has a duty to put the patient first above all else.

Read More About Value Analysis For Providers

 

Sources:

  1. E. (2018, March 23). Recall Index and Spotlight. Retrieved August 26, 2018, from https://www.stericycleexpertsolutions.com/recall-index/
  2. Maude database
    1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/TextSearch.cfm
  3. Recall database
    1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm
  4. E. (2018, March 23). Recall Index and Spotlight. Retrieved August 26, 2018, from https://www.stericycleexpertsolutions.com/recall-index/

 

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