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Occasionally a healthcare facility or safety organization just runs out of ideas on how to resolve a problem - or improve on a process that has demonstrated the need. They find it efficient and economical to look beyond their own organization to advisors who have worked in hundreds of similar facilities across the nation.

  • Perhaps a hospital has noticed an increasing trend in lawsuits resulting from poor inter-departmental communication between their Emergency Department and other support departments resulting in missed or delayed patient diagnosis.
  • Perhaps a healthcare facility is unsure of what performance requirements to place into the service contracts with external service providers and vendors. Or, worse yet, don't know how to measure the performance of such vendors to assure that they are avoiding risk or regulatory exposures while receiving top value for their contracting funds.
  • Perhaps a healthcare system expands in size and scope and finds that it now has 6-7 ways to perform a single process or procedure that is more dependent on the location - than on the procedure itself. They are inspired to know that a universal procedure approach will automatically translate the value of using one training method for one procedure… as opposed to training staff six different ways to perform a singular procedure - and thus will avoid chaos and errors.

A Sample Customized Solution
In July 2005, we were commissioned by UCLA Healthcare in Los Angeles, California to develop a Tag and Sequester Program for defective medical devices. Our program solution was destined to be used by all UCLA facilities and national members of MedSun1 - a prominent medical device safety network.

UCLA and MedSun challenged us to create a solution intended to:

  • Ensure that the safety of patients, staff and facility property are protected against harm resulting from dysfunctional medical devices
  • Coordinate intra- and inter-departmental efforts in a collaborative manner to promote the identification, designation, removal from service, assessment, repair (and replacement as needed) of ALL clinical, electrical and mechanical devices that:
  • Present the potential for harm;
  • Have contributed to harm as a result of malfunctioning;
  • Are in use beyond the designated date that the device was scheduled for inspection, maintenance and testing evaluation.

In response to this challenge, we created the Stop - Tag - And - Report (STAR) Program for presentation to the leadership team of UCLA, executive leaders of MedSun and FDA representatives. You may view a Power Point presentation of the STAR program to examine a portion of this customized solution.

1 Medical Product Surveillance Network (MedSun) is a pilot program launched in 2002 by the U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH). The primary goals for MedSun are to identify, understand and share information about problems with the use of medical devices. MedSun plays an important role in FDA's post-market surveillance effort.

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