Lessons Learned

Expired Medical Implants
Lessons from the CHPSO Database

According to the FDA, an implantable device or medical implant refers to devices or tissues placed either inside or on the surface of the body. Implants may be temporary or permanent, and serve a variety of purposes. Some common examples include:

  • Replacement of missing body parts (i.e., prosthetics)
  • Providing support to organs and tissues (i.e., surgical mesh)
  • Medication delivery (i.e., chemotherapy ports)

While medical implants may be necessary to treat disease and/or improve quality of life, there are risks associated with their use. This is true of all surgical procedures and every precaution should be taken to minimize the risk of patient harm.

In 2018, JAMA published a study examining incorrect surgical procedures across a large US health system. These authors found a total of 277 adverse events and 206 near misses. Among the adverse events, ophthalmology, dentistry, anesthesia, and orthopedics were the top four specialties reported. Across all of the 277 cases there were a total of 86 classified by the authors as “wrong implant”. This category included expired implants with expired ocular lenses, representing 52 of the cases.

Recently, CHPSO conducted a review of safety event reports related to expired implantable devices. We reviewed 170 reports and found a variety of expired implantable devices. Examples of expired medical device types included:

  • Ocular lenses
  • Bone cement
  • Mesh
  • Screws
  • Shunts

Some of these cases involved a near-miss in which the staff noticed  the device was expired before it was implanted. In these cases, the item would either be replaced with a non-expired item, or the provider would make the decision to use the item if there was no other alternative.  In other cases, the team did not know the item was expired until it had already been implanted. Sometimes, the item could still be removed and replaced with another device. In other cases, the potential for harm in attempting to remove the device was considered to be greater than leaving the expired device in place.

For expired medical devices that were implanted, without recognition of the expiry date having passed, the expiration date was commonly noticed when the RN staff were documenting the case in the patient’s medical record. This would indicate potential opportunities for improvement in supply-chain management, team communication, and perhaps in the “time-out” process. Recommendations for improvement from the authors of the study cited above include:

  • Ensuring clinicians adhere to universal protocol
  • Performing complete and mindfully conducted “time-outs”
  • Maintaining adequate leadership support for best practices
  • Incorporating strong peer-to-peer communication, including sharing lessons learned.

Resources and References

Croke, L. (2019). Updated statistics underscore the importance of the surgical time out. AORN journal, 109(6), P5-P5. Available here.

Neily, J., Chomsky, A., Orcutt, J., Paull, D. E., Mills, P. D., Gilbert, C., … & Gunnar, W. (2018). Examining wrong eye implant adverse events in the Veterans Health Administration with a focus on prevention: a preliminary report. Journal of patient safety, 14(1), 49-53. Abstract only available here.

Neily, J., Soncrant, C., Mills, P. D., Paull, D. E., Mazzia, L., Young-Xu, Y., … & Gunnar, W. (2018). Assessment of Incorrect Surgical Procedures Within and Outside the Operating Room: A Follow-up Study From US Veterans Health Administration Medical Centers. JAMA network open, 1(7), e185147-e185147. Available here.

Mushtaq, F., O’Driscoll, C., Smith, F. C., Wilkins, D., Kapur, N., & Lawton, R. (2018). Contributory factors in surgical incidents as delineated by a confidential reporting system. The Annals of The Royal College of Surgeons of England, 100(5), 401-405. Available here.