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.
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:
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.
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
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.
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