Recall: 3M Steri-Drape Defect Can Render Product Unusable and Unsafe
Recently, 3M™ issued an urgent, voluntary recall of select models and lots of 3M™ Steri-Drape™ Surgical Drapes distributed between October 29, 2021, and August 25, 2022.
How is the drape used?
The Steri-Drape is made from clear polyethylene plastic with a matte finish, which includes an adhesive strip. It is used as a surgical drape for patients during procedures. This drape is intended to absorb liquids with no strike-through to decrease the risk of microbial migration, and function as a barrier to skin.
The effected products include: 3M™ Steri-Drape™ Surgical Drapes, Catalog Numbers 1000, 1000NS, 1000NSD, 1010, 1010NS, 1010NSD, 1020, 1020NS, 1021, 1021NS, 1030, 1030NS, 1033, 1060, 1060NS, 1061, 1061NS, and 1071.
The defect
A 3M investigation confirmed that the liner on the adhesive component of the drapes is difficult to remove without damaging the product and therefore, can render the product unusable and unsafe. The company also received an increase in reported adhesive related skin injuries for these affected lots.
“Although the acceptance criteria for the device was met upon product release, the adhesive component may not meet 3M’s performance criteria throughout product shelf life. 3M requests customers cease use of the product and quarantine it for destruction/disposal,” the company wrote.
Action needed
Any facility in possession of the drapes is urged to take the following steps:
- Immediately discontinue distribution of affected models and lots of 3M™ Steri-Drape™ Surgical Drapes.
- Determine if any stock of the affected models and lots remains in inventory.
- Complete the distributor acknowledgement.
- Notify customers who have purchased this product.
Get alternative products information, insight, and vendor availability
With ECRI’s functional equivalents and vendor availability report for drapes, healthcare supply chain and clinical leaders can quickly identify viable alternatives.
They also can see key performance indicators (KPIs) in the report for the categories they need. This allows them to immediately identify any differences in device functioning or appropriate procedures.
An ECRI alternative can be a 90% match because we provide information, context, and insight that saves time and allows you to make better decisions.
ECRI provides reports that allow the user to quickly identify alternatives and have KPIs right in front of them for the categories they need, so they can identify any difference in the alternative products in function, effectiveness, and appropriateness for certain procedures. The alternatives can be a close match in one category but not so close in another. ECRI provides the insight to make sense of that and saves you time.
This recall is another reminder of the interdependence between patient safety and supply chain. They are not separate parts of healthcare that should function independently of each other. Rather, their interdependence is vital to increasing patient safety; creating efficient, safe, and successful working environments; and maintaining the fiscal viability of healthcare facilities.
Effectively addressing recalls is part of a resilient supply chain. Contact ECRI to learn how we can help you build a proactive, resilient supply chain.