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Returning explants to patients

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An interesting observation on safety issues raised in returning contaminated items such as jewelry to clients, as voiced by this medical professional’s concerns for their patients. It is evident that infection control measures should be carefully considered when previously worn jewelry or other contaminated personal items are to be returned to a customer.

Please regard the discussion in the comments below


Question

I am an OR nurse and recently started a new job in a prestigious orthopedic hospital. At the request of a surgeon or patient when implants are removed we have been cleaning and flashing them and returning them to the patient in a plastic bag.

[NOTE: Flashing is an outdated term for sterilizing items unwrapped for immediate use]

At my previous hospital we never would do this as it was considered unsafe and a possible infection hazard. I questioned the peri-operative educator about this practice and she stated there was nothing wrong with doing this and there was no regulation against returning explants to patients. Frankly, I am appalled at this practice. Can you tell me if there is any professional standard on this or if this is an acceptable practice?

Answer

Ray Taurasi — Healthmark Industries
Ray Taurasi — Healthmark Industries

There is no universal standard or regulation on this practice. In my experience the decision and process is left to each hospital to decide and to develop a hospital policy.

In developing a policy on the return of explants to patients there are many concerns and issues that need to be considered and addressed. It is suggested that a task force or committee be established, bringing together the required expertise to develop a sound and rational policy. Representation on the committee may include surgeons, peri-operative staff, infection control, epidemiology, risk management, legal affairs, manufacturer, sterile processing, pathology and materials management. Each committee representative or grouping of representatives will investigate issues related to their area expertise. The following is a list of some of the concerns and issues to address.

  • Reprocessing of implants
  • Method of cleaning, decontamination and sterilization for each type of explants
  • Personal safety, injury risk assessment associated with explants to be processed and returned to patient
  • Identify which explants can and cannot be returned to patients
  • QA of reprocessing efficacy
  • Packaging and labeling of device for sterilization and return to patient
  • Adherence to any biohazard handling or labeling in accordance with federal, state and local regulations
  • Who rightfully has ownership rights to the explant
  • Issues involving past, current or future implant recalls — and compliance to FDA regulations — e.g. tracking, ownership, reporting, return to manufacturer
  • Compliance with FDA and/or other regulatory mandates relating to disbursement and distribution of such devices
  • Maintenance of required documents and manifestos for tracing purposes
  • What other records will hospital create and maintain
  • Who, when, where and how will explants be returned to patient

Reference: February 2012+AORN Journal Vol. 95, Issue 2, Pages 288-296 Returning Explants to Patients AORN 2012 PDF

From Healthcare Purchasing News

Ray Taurasi is Eastern Regional Director of Clinical Sales and Services for Healthmark Industries. His healthcare career spans over three decades as an Administrator, Educator, Technologist and Consultant. He is a member of AORN, AHA, SGNA, AAMI and a past president of IAHCSMM and has served on and contributed to many national committees with a myriad of professional organizations, manufacturers, corporations and prestigious healthcare networks. Taurasi has been a faculty member of numerous colleges teaching in the divisions of business administration and health sciences. In addition to this column he has authored several articles and has been a featured speaker on the international scene.


Recommendations by the Quality Task Group (91)

Implants for Orthopaedics and Traumatology

 

Recommendations by the Quality Task Group (93)

Reprocessing implants, supplied in an unsterile state, for orthopaedics and traumatology – Part 2

To avoid contamination with particles, implants must not be cleaned or disinfected together with other used medical devices. Ideally, a dedicated washer/disinfector should be available for implants.

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