Following an alert from an occupational health manager at a U.S. hospital, researchers with the Association of Occupational Health Professionals in Healthcare (AOHP) found a longstanding sharps injury problem with prefilled syringes that were designed as safety devices.
The researchers studied medical device adverse event reports (MDRs) for near-misses, malfunctions, and injuries involving the safety mechanisms of Lovenox/enoxaparin prefilled syringes, which are used to prevent blot clots and deep vein thrombosis.
“Examination of MDRs confirmed device malfunction had been occurring for at least 10 years, was associated with sharps injuries to healthcare personnel (HCP), [and] had not decreased with time,” the authors reported.1
The study results highlight the need for simpler adverse event reporting and more effective intervention by the FDA and device manufacturers.
“Four national adverse event databases were examined over a 12-year period for incidence and brands involved with injury events to staff using enoxaparin prefilled syringes,” the authors reported. “The search revealed 581 adverse events (including 20 sharps injuries) associated with device malfunction in eight of 16 brands.”
Some of the reported problems included:
- The needle/shield forcefully ejecting when the safety mechanism activated;
- Syringes falling apart when the plunger is activated;
- The safety mechanism activating prematurely before injection was completed;
- Syringes failing to activate when force was placed on the plunger;
- Needing excessive force to activate the safety mechanism.
One sharps injury occurred after it was used for a patient with HIV infection, which generally is followed by post-exposure prophylaxis to prevent seroconversion. “This has been so effective we rarely hear of a needlestick leading to seroconversion, though healthcare workers are still at risk of bloodborne pathogens, particularly those downstream of needle use like laundry workers or environmental services,” said Amber Mitchell, DrPH, MPH, CPH, president and executive director of the International Safety Center.
Speaking at a recent AOHP webinar on sharps injuries and the OSHA, Mitchell said OSHA injury logs may capture a needlestick as a moment in time, but a subsequent seroconversion may not be connected to the exposure.
“OSHA doesn’t have the capacity really to evaluate that data and to tie that illness back to that incident,” Mitchell said. “CDC has stopped collecting occupational seroconversions altogether, so it looks like they don’t happen. Post-exposure prophylaxis is really good, especially if it’s done quickly, so seroconversions are a lot lower than they used to be.”
Citing some of the Safety Center’s EPINet data, Mitchell said most injuries are related to suturing and scalpels in the operating room. “We’re seeing more and more injuries from hypodermic syringes used for skin injection, mostly from vaccine programs,” Mitchell noted.
There are safety devices for these instruments, but too often they are not used, or the safety feature is not activated. “In the U.S., more than 300,000 HCP sustain sharps injuries annually,” the authors of the AOHP paper concluded. “The incidence is not decreasing, injuries may transmit more than 60 pathogens, and they can cause high anxiety and emotional trauma in injured HCP.”
When injury or sharps device malfunction occurs, conduct a root cause analysis and mitigate contributing factors.
“Injured users too readily blame themselves and cite ‘user error,’” the authors noted.
REFERENCES
- Grimmond T, Gruden M, Hurst BJ, Crutchfield LF. Sharps injuries with Lovenox and generic enoxaparin prefilled safety syringes: A 12-year retrospective cross-sectional analytical study. Nursing 2023;53: 53-61.
Following an alert from an occupational health manager at a U.S. hospital, researchers with the Association of Occupational Health Professionals in Healthcare found a longstanding sharps injury problem with prefilled syringes that were designed as safety devices.
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