Glass particles in drugs that are delivered in glass ampules

Liquid drugs are frequently delivered in glass ampules. The opening of glass ampules may generate glass particles that can contaminate the drug when the ampule is broken. The glass particles might be transferred to a patient via injection of infusion.

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SBU Enquiry Service

Consists of structured literature searches to highlight studies that can address questions received by the SBU Enquiry Service from Swedish healthcare or social service providers. We assess the risk of bias in systematic reviews and when needed also quality and transferability of results in health economic studies. Relevant references are compiled by an SBU staff member, in consultation with an external expert when needed.

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Published: Report no: ut202312 Registration no: SBU 2022/680

Question

What scientific studies are published on 1) the presence of glass particles in drugs from glass ampules drawn with or without filter needle, and 2) documented clinical complications from glass particles in drugs?

Identified literature

No relevant systematic review was identified but nine primary studies were identified [1–9]. The primary studies were not assessed for risk of bias.

References

  1. Carbone-Traber KB, Shanks CA. Glass particle contamination in single-dose ampules. Anesth Analg. 1986;65(12):1361-3.
  2. Driscoll DF, Lawrence KR, Lewis K, Bistrian BR. Particle size distribution of propofol injection from ampules and vials: the benefits of filtration. Int J Pharm Compd. 1997;1(2):118-20.
  3. Erkoc Hut A, Yazici ZA. Glass particle contamination threat in nursing practice: A pilot study. J Adv Nurs. 2021;77(7):3189-91. Available from: https://doi.org/10.1111/jan.14847.
  4. Joo GE, Sohng KY, Park MY. The effect of different methods of intravenous injection on glass particle contamination from ampules. Springerplus. 2016;5:15. Available from: https://doi.org/10.1186/s40064-015-1632-0.
  5. Preston ST, Hegadoren K. Glass contamination in parenterally administered medication. J Adv Nurs. 2004;48(3):266-70. Available from: https://doi.org/10.1111/j.1365-2648.2004.03195.x.
  6. Sabon RL, Jr., Cheng EY, Stommel KA, Hennen CR. Glass particle contamination: influence of aspiration methods and ampule types. Anesthesiology. 1989;70(5):859-62.
  7. Sandell E, Ernerot L. Membrane filtration during administration for elimination of glass particles from ampoules. Acta Pharm Suec. 1968;5(2):111-3.
  8. Zabir AF, Choy CY, Rushdan R. Glass particle contamination of parenteral preparations of intravenous drugs in anaesthetic practice. Southern African Journal of Anaesthesia and Analgesia. 2008;14(3):17-9. Available from: https://doi.org/10.1080/22201173.2008.10872550.
  9. Hafez MA, Al-Dars AM. Glass foreign bodies inside the knee joint following intra-articular injection. Am J Case Rep. 2012;13:238-40. Available from: https://doi.org/10.12659/AJCR.883492.

Literature search

Medline via OvidSP 28 October 2022, updated 15 March 2023

Title: Filtration of glass delamination particles.
/ = Term from the MeSH controlled vocabulary; exp = Term from MeSH, including terms found below this term in the MeSH hierarchy; .ti,ab = Title or abstract; .tw = Title or abstract; .kf = Keyword Heading Word; .bt = Book title; NLM Bookshelf; adjn = Adjacent; proximity operator retrieving adjacent words, adj3 retrieves records with search terms within two terms from each other; * = Truncation
Search termsItems found
Injection etc.
1. exp Catheters/ 35394
2. Syringes/ 6649
3. Needles/ 17054
4. exp Administration, Intravenous/ 148257
5. Injections, Intramuscular/ 32037
6. (intraven* adj3 (drip or infus*)).ti,ab,bt,kf. 41645
7. (ampoul* or ampul* or cannul* or cathet* or intramuscular inject* or needl* or syring* or vial*).ti,ab,bt,kf. 465924
8. or/1–7 668408
Filter
9. exp Filtration/ 38358
10. (filter* or filtr*).ti,ab,bt,kf. 308956
11. or/9–10 326318
Glass
12. Glass/ 18921
13. glass.ti,ab,bt,kf. 110758
14. or/12–13 116116
Glass particulate
15. (glass adj3 (contam* or delaminat* or flake* or fragm* or partic*)).ti,ab,bt,kf. 1858
Combined sets:
16. 11 AND 14 3943
17. 15 OR 16 5707
Final result
18. 8 AND 17 320

Embase via Elsevier 28 October 2022, updated 15 March 2023

Title: Filtration of glass delamination particles.
The final search result, usually found at the end of the documentation, forms the list of abstracts.
/de = Term from the EMTREE controlled vocabulary; /exp = Includes terms found below this term in the EMTREE hierarchy; :ab = Abstract; :kw = Author keyword; :ti = Article Title; :ti,ab = Title or abstract; * = Truncation; ' ' = Citation Marks; searches for an exact phrase; NEAR/n = Requests terms that are within 'n' words of each other in either direction
Search termsItems found
Injection etc
1. 'catheter'/exp 238531
2. 'syringe'/exp 25021
3. 'cannula'/exp 25042
4. 'ampoule'/de 1872
5. 'intravenous drug administration'/exp 394961
6. 'intramuscular drug administration'/de 70043
7. (intraven* NEAR/3 (drip OR infus*)):ti,ab,kw 54311
8. ampoul*:ti,ab,kw OR ampul*:ti,ab,kw OR cannul*:ti,ab,kw OR cathet*:ti,ab,kw OR 'intramuscular inject*':ti,ab,kw OR needl*:ti,ab,kw OR syring*:ti,ab,kw OR vial*:ti,ab,kw 690761
9. 1 OR 2 OR 3 OR 4 OR 5 OR 6 OR 7 OR 8 1250670
Filter
10. 'filter'/exp 71817
11. filter*:ti,ab,kw OR filtr*:ti,ab,kw 392383
12. 10 OR 11 408250
Glass
13. 'glass'/de 42964
14. glass:ti,ab,kw 118690
15. 13 OR 14 124882
Glass particulate
16. (glass NEAR/3 (contam* OR delaminat* OR flake* OR fragm* OR partic*)):ti,ab,kw 2080
Combined sets
17. 12 AND 15 4867
18. 16 OR 17 6815
Final result
19. 9 AND 18 463
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