Detecting Endotoxin Contamination of Ophthalmic Viscosurgical Devices

Buchen, Shelley Y.; Calogero, Don; Hilmantel, Gene; Eydelman, Malvina B.

doi:10.1016/j.ophtha.2012.04.005

Cited by 16 publications

(8 citation statements)

References 9 publications

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“…Results suggest that the 3% HA OVD was contaminated with the bacterial endotoxin from the outset, whereas the 1% HA OVD showed no detectable level of the bacterial endotoxin. Nondigested 3% HA OVD alone cannot be assayed for the presence of bacterial endotoxin because of its high viscosity 13 and difficulty in handling small volumes accurately. Figure 4 shows the results of bacterial endotoxin detection in 2% HA-based dermal filler, as received or spiked with 24 EU/mL of bacterial endotoxin, which were then digested prior to testing.…”

Section: Hyaluronidases Testing For the Bacterial Endotoxinmentioning

confidence: 99%

“…12 FDA researchers investigated the causes of TASS outbreaks as adverse events 13 ; and developed new testing methods to determine the inflammatory potential of suspected contamination of subject devices. [14][15][16][17][18][19][20][21] In 2012, Buchen et al evaluated an inflammatory potential of cohesive and dispersive OVDs which were spiked with known endotoxin concentrations, 13 and were measured using the LAL kinetic turbidimetric assay. Rabbits were given known concentrations of bacterial endotoxins mixed with HA and the researchers noted the concentration at which of endotoxin caused inflammation in the eye.…”

Section: Introductionmentioning

confidence: 99%

“…They also noted that because the HA was so viscous, it was difficult to obtain accurate amount of samples to measure bacterial endotoxins using the LAL assay. 13 16 These events may have occurred due to the surgical procedure technique (depth and the correct placement of injection itself), concentration of the product used (excessive amount), protein and endotoxin contamination, and lowmolecular-weight HA fragments generated during biological degradation. 8,[17][18][19][20] The focus of this study is to develop a simple and rapid method for testing the presence of bacterial endotoxin in HA-based medical devices.…”

Section: Introductionmentioning

confidence: 99%

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Bacterial endotoxin detection in hyaluronic acid-based medical devices

Baeva

Das

Hitchins

2016

J. Biomed. Mater. Res.

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Section: Hyaluronidases Testing For the Bacterial Endotoxinmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Bacterial endotoxin detection in hyaluronic acid-based medical devices

Baeva

Das

Hitchins

2016

J. Biomed. Mater. Res.

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“…OVD can be contaminated by toxins and indeed have been in the past in several welldocumented instances [24]. No OVD means one intruder into the inner sanctum of the eye less and therefore less chance for infection or irritation [22].…”

Section: Rendering Phaco Energy (Almost) Obsoletementioning

confidence: 99%

Femtosecond cataract surgery overcoming clinical challenges

Dick¹,

Gerste²,

Schultz³

2013

Expert Review of Ophthalmology

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Cataract surgery has been undergoing revolutionary changes over the last 5 years, welcomed by a number of surgeons, reluctantly observed and sometimes critically commented upon by others. The femtosecond laser has introduced new standards in precision and reproducibility when it comes to corneal incisions and capsulotomies, it has changed the way we deal with the lens: originally conceived as a 'pretreatment', the laser is on the way to render the original treatment -phacoemulsification -obsolete. In a relatively short time, challenging clinical situations have been tackled successfully: small pupils, mature cataracts and even congenital cataracts. With growing experience, the use of ultrasound energy could be substantially reduced, in most cases even eliminated and thus the chance of ultrasoundrelated complications. We also have reason to envision performing cataract surgery without employing ophthalmic viscosurgical devices. These developments have the potential to make cataract surgery significantly safer.

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“…Retinal tamponades are ophthalmic viscosurgical devices (OVD), which are viscous and viscoelastic intraocular fluids used during a variety of surgeries to create and maintain space in the anterior chamber to protect internal eye tissues. However, they may be contaminated with endotoxin as well [19,20]. Due to the serious risks associated with endotoxin, the U.S. Food and Drug Administration (FDA) has issued endotoxin testing recommendations for intraocular single-use ophthalmic devices for industry.…”

Section: Introductionmentioning

confidence: 99%

Rapid detection of bacterial endotoxins in ophthalmic viscosurgical device materials by direct analysis in real time mass spectrometry

Hitchins

Wickramasekara

2016

Analytica Chimica Acta

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Bacterial endotoxins are lipopolysaccharides bound to the bacterial cell wall and released when bacteria rupture or disintegrate. Possible contamination of endotoxin in ophthalmic devices can cause a painful eye inflammation or result in toxic anterior segment syndrome after cataract surgery. Measurement of bacterial endotoxin in medical device materials is difficult since endotoxin binds with polymer matrix and some of the materials are very viscous and non-water soluble, where traditional enzyme-based Limulus amebocyte lysate (LAL) assay cannot be applied. Here we propose a rapid and high throughput ambient ionization mass spectrometric (MS) method using direct analysis in real time (DART) for the evaluation of endotoxin contamination in medical device materials. Large and structurally complex endotoxin instantaneously breaks down into low-mass characteristic fragment ions using DART and is detected by MS in both positive and negative ion modes. This method enables the identification and separation of endotoxin from medical materials with a detection limit of 0.03 ng mL−1 endotoxins in aqueous solution. Ophthalmic viscosurgical device materials including sodium hyaluronate (NaHA), non-water soluble perfluoro-n-octane (PFO) and silicone oil (SO) were spiked with different known concentrations of endotoxin and analyzed by DART MS, where the presence of endotoxin was successfully detected and featured small mass fragment ions were generated for NaHA, PFO and SO as well. Current findings showed the feasibility of measuring endotoxin contamination in medical device materials using DART-MS, which can lead to a one-step analysis of endotoxins in different matrices, avoiding any potential contamination during sample pre-treatment steps.

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Detecting Endotoxin Contamination of Ophthalmic Viscosurgical Devices

Cited by 16 publications

References 9 publications

Bacterial endotoxin detection in hyaluronic acid-based medical devices

Bacterial endotoxin detection in hyaluronic acid-based medical devices

Femtosecond cataract surgery overcoming clinical challenges

Rapid detection of bacterial endotoxins in ophthalmic viscosurgical device materials by direct analysis in real time mass spectrometry

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