2017-18 HSC Section 4 Green Book

P ART I A L L Y U S ED HYA L URON I C AC I D F I L L E R S

Mycobacterial Detection System (Becton Dickinson Microbiology Systems, Sparks, MD). Enriched liquid media Todd Hewitt broth tubes were incubated at 37 C in CO 2 incubator for 14 days and observed daily for any turbidity. The MGIT was placed into the BAC- TECMGIT 960, where the cultures were continuously monitored for 6 weeks after which time they were considered negative. If there was any indication of growth, the fl uid from the tube was inoculated on sheep blood agar, chocolate agar, MacConkey agar, anaerobic agar media, and Sabouraud ’ s media for fungal culture. All aerobic and anaerobic culture media were incubated for a total of 14 days. All col- onies grown were Gram stained and full identi fi cation and susceptibility were performed using the fully automated VITEK Immunodiagnostic Assay System (BioM´erieux, Marcy-l ’ Etoile, France). There was no growth in any of the fungal and acid-fast bacilli culture media in any of the 36 syringes cultured. However, there were 5 positive bacterial cultures that resulted in predominantly Staphylococcus species as follows: samples 16, 20, and 29 were Staphylococcus epidermidis , sample 32 was a Corynebacterium spe- cies and sample 36 was a Bacillus species (storage durations in months were 46.9, 52.27, 52, 67.77, and 71.57, respectively). Results A retrospective paper published in 2010 supported the theory that injectable HA fi llers can be stored in a refrigerator under clean conditions without evidence of contamination for 2 years. The study tested the stored materials for bacterial, mycobacterial, and fungal contaminants. 2 Another 2 studies tested HA fi llers stored at room temperature for bacterial growth, which was not evident, and they concluded that reuse of the remaining material in the syringe may be safe and more economical than discarding it. 1,3 A retrospective chart review study of patients injected with stored HA fi llers also showed that there was minimal risk of bacterial infection associated with the use of stored fi llers. 4 The earliest study that ques- tioned and tested this issue was performed on collagen Discussion

Methods

The study was performed at the Medical City of King Saud University in Riyadh. It included products from Juv´ederm Ultra Plus (Allergan, Irvine, CA) and Restylane (Q-med, Sweden). The patients were ini- tially injected with some of the fi ller between January 1, 2009, and December 31, 2012, at a dermatology clinic. Before injection, the patients ’ skin was prepared with povidone iodine and then cleansed with 70% isopropyl alcohol before the fi llers were administered using sterile needles. The remaining, unused HA material from 36 syringes was stored at room tem- perature. Exchanging the needle used for the initial augmentation procedure with the original tip cap, which had been stored on a sterile surface, or with a new sterile needle was considered a critical step before storing any syringe to avoid retrograde micro- bial contamination (Figure 1). All the samples were returned to their original packets directly after injec- tion and syringes and packets were both labeled with each patient ’ s name, record number, and the date of the procedure. The syringe was then stored at room temperature in a clean cabinet with a mean storage duration of 57.8months. The longest storage duration was 71.57months and the shortest was 32.87 months. At the end of the storage period in August 2015, each syringe was subjected to in vitro testing for the growth of microbes, including aerobic and anaerobic bacteria, mycobacteria, and fungi.

Culture Protocol

The remaining material from each syringe was inoc- ulated in both enriched liquid media Todd Hewitt broth (Difco Laboratories) and Mycobacterium Growth Indicator Tube (MGIT) BACTEC MGIT 960

Figure 1. Hyaluronic acid syringes. The needles have been removed after use and replaced with tip caps.

DE RMATOLOG I C S URG E RY

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