FDA Considers Regulating Refurbishers and Other Third Parties

POSTED IN FDA, INTERNATIONAL HEALTHCARE, LEGISLATION, MEDICAL DEVICE, MEDICAL DEVICE, PHARMACEUTICAL, QUALITY AND PERFORMANCE MEASURES,REGULATORY COMPLIANCE
The Food and Drug Administration (FDA) requested comments on March 4 regarding definitions and possible regulations governing medical device refurbishers, reprocessors, and other third parties.

Medical device manufacturers have the duty, under 21 C.F.R. Part 820, to provide instructions to third parties that may service or install their products.  However, manufacturers may not be able to maintain control over their device after it leaves their hands, which can be a problem especially if the device is not repaired correctly or a third party changes the product.  Stakeholders expressed concerns regarding the safety and effectiveness of medical devices that undergo one or more activities by a third party.  FDA proposed adding seven definitions for third parties and the activities they perform on already-manufactured medical devices:

  • Recondition: Restores and/or refurbishes a medical device to the OEM’s original specifications. Under limited circumstances the medical device may be restored and/or refurbished to current specifications.
  • Service: Maintenance or repair of a finished device after distribution to return it to the safety and performance specifications established by the OEM and to meet its original intended use. Servicing cannot change the intended use(s) of the device from its original purpose(s).
  • Repair: Return the device or component to original specifications including replacing non-working components or parts outside of routine or periodic upkeep for the current owner of the device.
  • Refurbish: Restore device to a condition of safety and effectiveness that is comparable to when new. This includes reconditioning, repair, installation of certain software/hardware updates that do not change the intended use of the original device, and replacement of worn parts.
  • Remanufacture: Process, condition, renovate, repackage, restore, or any other act done to a finished device that significantly changes the finished device’s performance, safety, specifications, or intended use.
  • Remarket: The act of facilitating the transfer of a previously owned device from one party to another by sale, donation, gift, or lease.

Continue reading…

End Times: Planning for Capital Equipment Purchases

Published on March 4, 2016

By Dallas T. Sutton, Jr, CRES

Planning for Capital Equipment Purchases

Preparation begins long before devices hit their life expectancy

 

The key to capital equipment management is planning. That perspective is not unfamiliar to or contested by most of us, but what does planning mean?

Generally, when we plan to replace a device, there are many factors to consider, not the least of which is the financial impact to the organization. How often and why you replace your capital equipment will inevitably affect the bottom line. All of us have the responsibility to maintain each piece of equipment as efficiently and economically as possible, but let’s face it—at some point, every device will leave the building.

The good news is that time should come as no surprise. You will still have the occasional emergency requisition when the central station floods during a water main break or a manufacturer’s recall forces you to pull a device out of service sooner than expected. But for the most part, there is ample opportunity to plan for the replacement of every device in your inventory.

Many organizations use some sort of equipment planning document like a “5-Year Capital Replacement Plan” to aid in this process. However, the content of this document, as well as the organization’s reverence for its recommendations, will vary greatly. More often than not, these documents are generated at least in part by the Clinical Engineering department. The responsibility to provide the most accurate and impartial data to organizational leadership therefore falls square on our shoulders. So, what information do you need to provide, where do you get it, and who needs to receive it?

Continue reading…24×7 Magazine