Answer Library / PPE & First Aid OSHA letter · 2019-09-06

Do shipping boxes with blood-contaminated medical devices need OSHA biohazard labels?

Quick answer

Yes, in some cases. If equipment cannot be decontaminated before shipping, an OSHA biohazard label stating which portions remain contaminated is required (29 CFR 1910.1030(g)(1)(i)(H)). When DOT labels are not required but an exposure risk exists, the Bloodborne Pathogens labeling requirements apply to the tertiary (outer) shipping package.

A medical device manufacturer asked OSHA whether biohazard labels are required on tertiary shipping packages containing potentially infectious medical devices when Department of Transportation (DOT) labels are not required. The question matters because contaminated devices are often returned for servicing in multi-layer packaging.

OSHA explained that the Bloodborne Pathogens standard requires equipment potentially contaminated with blood or other potentially infectious materials to be decontaminated before servicing or shipping unless that is infeasible (29 CFR 1910.1030(d)(2)(xiv)(A)). When decontamination cannot occur, a readily observable label meeting 29 CFR 1910.1030(g)(1)(i)(H) must be attached, stating which portions of the equipment remain contaminated.

On the overlap with DOT rules: where DOT labels are required, they satisfy the external container labeling as long as the OSHA biohazard label appears on internal containers. But when DOT labels are not required and an exposure risk exists from the contents, the Bloodborne Pathogens standard's labeling requirements must be followed on the tertiary shipping package itself.

29 CFR 1910.1030(d)(2)(xiv)(A)29 CFR 1910.1030(g)(1)(i)(H)
Source: OSHA Standard Interpretation letter, 2019-09-06 — read the official letter on osha.gov →
Interpretation letters explain how OSHA applies its rules to specific situations. Always verify current requirements — regulations and enforcement policies change.

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