Cost–Benefit Analysis of Single versus Repeated Use of Single-Use Devices in Cataract Surgery

Figures & data

Table 1 List of Primary and Possible Concomitant Secondary Complications Included in the Model

Primary Complication	Possible Concomitant Secondary Complication	Additional Specifications
Posterior capsule rent	Nucleus drop	Vitreous present in the anterior chamber
		No vitreous present in the anterior chamber
	No nucleus drop	Vitreous present in the anterior chamber
		No vitreous present in the anterior chamber
Acute endophthalmitis	Visual acuity better than light perception
	Visual acuity no better than light perception
Chronic endophthalmitis	Nidus of infection in IOL or capsular bag
	Nidus of infection not in IOL or capsular bag
Cornea tunnel infection	Resolution of infection with topical antibiotics only
	Progression of infection despite medical therapy/need for a corneal patch graft
Toxic anterior segment syndrome (TASS)	Cornea melt
	No cornea melt
Prolonged postoperative inflammation	None
Cystoid macular edema	Improvement after 3 months
	No improvement after 3 months
Elevated intraocular pressure on the first postoperative day	None
Postoperative hypotony due to a Seidel-positive corneal wound	Brisk flow from main wound
	Slow flow from main wound	Wound closure without surgical revision
		Wound closure after surgical revision
Corneal edema in the immediate postoperative period	None
Corneal edema months to up to 1 year after the procedure	None
Phaco wound burn	Ability to suture the wound
	Inability to suture the wound	Postoperative leakage from main wound, despite application of cyanoacrylate glue and bandage contact lens, requiring a corneal patch graft
		No leakage from main wound postoperatively after application of cyanoacrylate glue and bandage contact lens
Retinal detachment	None
Postoperative astigmatism	None

Table 2 Model Inputs

Input	Values (€)	Source
Cost data
Procedure/hospitalization	973.94	Greek DRG system (adjusted for wages)^Citation20,Citation21
Medications	13.86	Official Medication Price Bulletin^Citation19
Postoperative visits	52	EOPYY^Citation22
SUDs	100.4	Manufacturer
Sterilization of SUDs per procedure	3.06	Landouzy et al(2015)^Citation27
Mean daily wage	29.01	Labour Institute GSEE^Citation24
Minimum daily wage	21.84	National Legislation^Citation25
Transfer expense	5.00	Assumption
Adverse Events Costs
Posterior Capsule Rent	2,281.28	Greek DRG system adjusted for wages, Medications, Additional postoperative visits^Citation19^–^Citation22
Acute endophthalmitis	7,402.90
Chronic endophthalmitis	10,869.55
Cornea tunnel infection	8,424.06
Toxic anterior segment syndrome (TASS)	7,751.30
Prolonged postoperative inflammation	294.70
Cystoid macular edema	3,990.46
Elevated intraocular pressure on the first postoperative day	112.95
Postoperative hypotony due to a Seidel-positive corneal wound	771.88
Corneal edema in the immediate postoperative period^a	5,106.31
Corneal edema months to up to 1 year after the procedure	4,448.30
Phaco wound burn	2,902.71
Retinal detachment	2,047.80
Postoperative astigmatism	1,131.20^b
Epidemiological Data	Relative Risk (Reuse vs Single Use)	Source
Posterior Capsule Rent	1.070	Expert panel
Acute endophthalmitis	7.204
Chronic endophthalmitis	5.777
Cornea tunnel infection	9.459
Toxic anterior segment syndrome (TASS)	23.727
Prolonged postoperative inflammation	2.200
Cystoid macular edema	1.429
Elevated intraocular pressure on the first postoperative day	1.184
Postoperative hypotony due to a Seidel-positive corneal wound	2.766
Corneal edema in the immediate postoperative period	1.493
Corneal edema months to up to 1 year after the procedure	4.582
Phaco wound burn	3.510
Retinal detachment	1.112
Postoperative astigmatism	2.143

Notes: ^aThe cost of corneal edema in the immediate postoperative period includes the immediate treatment required as well as the cost of keratoplasty, weighted for the probability that the edema persists after 2 months. ^bThe cost of postoperative astigmatism includes additional cost for spectacles.²³

Table 3 Expected Additional Cost of Each Complication per Cataract Surgery per Patient, Healthcare Sector Perspective

Complication	Single Use (€)	Repeated Use (€)
None	0.00	0.00
Posterior Capsule Rent	16.26	17.40
Acute endophthalmitis	1.59	11.45
Chronic endophthalmitis	4.89	28.26
Cornea tunnel infection	0.80	7.60
Toxic anterior segment syndrome (TASS)	1.57	37.28
Prolonged postoperative inflammation	1.11	2.45
Cystoid macular edema	36.67	52.42
Elevated intraocular pressure on the first postoperative day	2.24	2.65
Postoperative hypotony due to a Seidel positive corneal wound	1.09	3.03
Corneal edema in the immediate postoperative period	62.49	93.32
Corneal edema months to up to 1 year after the procedure	7.43	34.05
Phaco wound burn	3.24	11.38
Retinal detachment	5.36	5.97
Postoperative astigmatism	15.01	32.18
Total	159.78	339.43

Table 4 Expected Additional Cost of Each Complication per Cataract Surgery per Patient, Societal Perspective

Complication	Single Use (€)	Repeated Use (€)
None	0	0
Posterior Capsule Rent	19.23	20.57
Acute endophthalmitis	1.98	14.23
Chronic endophthalmitis	5.92	34.18
Cornea tunnel infection	0.97	9.15
Toxic anterior segment syndrome (TASS)	1.86	44.12
Prolonged postoperative inflammation	1.29	2.83
Cystoid macular edema	41.23	58.94
Elevated intraocular pressure on the first postoperative day	2.54	3.01
Postoperative hypotony due to a Seidel-positive corneal wound	1.37	3.78
Corneal edema due to endothelial cell loss in the immediate postoperative period	68.47	102.25
Corneal edema months to years after the procedure due to endothelial cell loss	8.02	36.77
Phaco wound burn	3.49	12.27
Retinal detachment	5.74	6.38
Postoperative astigmatism	16.78	35.96
Total	178.87	384.45

Table 5 Results from Sensitivity Analysis: Mean Expected Additional Cost of Each Complication per Cataract Surgery per Patient Under a Single-Use Policy, a Reuse Policy and Its Difference Expressed in Euros

Costs	Reuse of SUDs	Single Use of SUDs	Difference (Reuse-Single Use)
Monetary cost of cataract surgery^a	1,146.86	1,244.20	−97.34
Procedure/hospitalization	973.94	973.94	0
Medications	13.86	13.86	0
Postoperative visits	156	156	0
SUDs	-	100.4	−100.4
Sterilization of SUDs per procedure	3.06	-	3.06
Adverse Events Costs^b	339.60	160.02	179.58
Posterior Capsule Rent	17.36	16.27	1.09
Acute endophthalmitis	11.42	1.53	9.89
Chronic endophthalmitis	28.27	4.97	23.31
Cornea tunnel infection	7.63	0.78	6.85
Toxic anterior segment syndrome (TASS)	37.42	1.58	35.84
Prolonged postoperative inflammation	2.44	1.12	1.32
Cystoid macular edema	52.46	36.72	15.74
Elevated intraocular pressure on the first postoperative day	2.65	2.24	0.41
Postoperative hypotony due to a Seidel-positive corneal wound	3.02	1.09	1.94
Corneal edema due to endothelial cell loss in the immediate postoperative period	93.44	62.74	30.69
Corneal edema months to up to 1 year after the procedure due to endothelial cell loss	34.06	7.45	26.60
Phaco wound burn	11.37	3.24	8.13
Retinal detachment	5.96	5.34	0.62
Postoperative astigmatism	32.10	14.95	17.15
Total cost of cataract surgery (95% CI)^c	* 1,486.47 (1,485.65 to 1,487.29)	** 1,404.21 (1,403.70 to 1,404.72)	*** 82.26 (81.29 to 83.22)
Range	1,349.58 to 1,669.28	1,319.71 to 1,512.17	−100.53 to 280.02

Notes: ^aThis is the sum of the following subcosts: procedure/hospitalization, medications, postoperative visits, SUDs and their sterilization” ^bThis is the sum of the following adverse events’ subcosts: posterior capsule rent, acute endophthalmitis, chronic endophthalmitis, cornea tunnel infection, toxic anterior segment syndrome, prolonged postoperative inflammation, cystoid macular edema, elevated intraocular pressure on the first postoperative day, postoperative hypotony due to a Seidel-positive corneal wound, corneal edema due to endothelial cell loss in the immediate postoperative period, corneal edema months to up to 1 year after the procedure due to endothelial cell loss, phaco wound burn, retinal detachment and postoperative astigmatism. ^cThis is defined as the monetary cost of cataract surgery in each case plus the cost of adverse events, as listed above. It is displayed as the mean values and its 95% confidence interval based on the results from the sensitivity analysis. * Total cost of cataract surgery with SUD reuse = monetary cost of cataract surgery with SUD reuse + adverse events costs with SUDs reuse. ** Total cost of cataract surgery with SUD single use = monetary cost of cataract surgery with SUD single use + adverse events costs with SUD single use. *** Difference of total cost of cataract surgery between SUD reuse and single use = Total cost of cataract surgery with SUD reuse - Total cost of cataract surgery with SUD single use. The final results of the analysis are highlighted in bold.

Abbreviations: SUD, single use device; CI, confidence interval.

Figure 1 Schematic representation of the sensitivity analysis for the difference (in classes) of the total expected cost of cataract surgery when SUDs are reused minus the total expected cost of cataract surgery when SUDs are used only once. Values are presented in euros.

Greek Diagnostic Related Groups System. [homepage on the internet]. Available from: http://kenicd.e-healthnet.gr/. Accessed November 15, 2020.

 Google Scholar

Hellenic Ministry of finance, Hellenic Ministry of labour, social insurance and welfare, Hellenic Ministry of health. ΦΕΚ 3096/Β/23.11.2012: Αριθμ. Υ4α/oικ.105494 [Government Gazette Issue 3096/Β/23.11.2012: Joint Ministerial Decision Υ4α/oικ.105494]; Athens: National Printing Office. Available from: http://www.et.gr/idocs-nph/search/pdfViewerForm.html?args=5C7QrtC22wEbA_BZxkczbHdtvSoClrL8Hcsihn8f1EIfP1Rf9veiteJInJ48_97uHrMts-zFzeyCiBSQOpYnTy36MacmUFCx2ppFvBej56Mmc8Qdb8ZfRJqZnsIAdk8Lv_e6czmhEembNmZCMxLMtUp6gROBB3AeQKo8RTWTCbwwgxBtjpIVgh1q-uwg-7Fa. Accessed March 22, 2021.

 Google Scholar

Ministry of Health. Medication Price Bulletin. Available from: https://www.moh.gov.gr/articles/times-farmakwn/deltia-timwn/6053-epikairopoihsh-deltiwn-timwn-farmakwn-logw-dioikhtikwnmetabolwn-kai-allaghs-f-p-a-12-2-2019. Accessed November 15, 2020.

 Google Scholar

Ministry of Finance, Ministry of Health. ΦΕΚ 1958/B/12-8-2013, Απόφαση Αριθμ Oικ. 72944 [Government Gazette Issue 1958/B/12-8-2013, Joint Ministerial Decision 72944]. Athens: National Printing Office. Available from http://www.et.gr/idocs-nph/search/pdfViewerForm.html?args=5C7QrtC22wEaosRGzKxO6XdtvSoClrL8vnZOzRHI6VLuFUDqazHcNeJInJ48_97uHrMts-zFzeyCiBSQOpYnTy36MacmUFCx2ppFvBej56Mmc8Qdb8ZfRJqZnsIAdk8Lv_e6czmhEembNmZCMxLMtbrLuXTahBK3eaKz7OnbV4kUsGqhjeki8Zogqmlz3hjF. Accessed March 22, 2021.

 Google Scholar

Landouzy M, Rossi M, Okiemy E, Velu MBI Comparative medical economical study about cataract surgery sets: single use versus reusable. Poster ID-146 presented at: 16th World Sterilization Congress & Annual conference of AFS; October 7-10; 2015; Lille, France. Available from: https://www.sf2s-sterilisation.fr/wp-content/uploads/2016/08/ID146_WFHSS_2015.pdf.Accessed March 22, 2021.

 Google Scholar

Labour Institute GSEE. Greek Economy and Employment. Annual Report 2019.; 2019. Available from: https://www.inegsee.gr/ekdosi/etisia-ekthesi-2019-ine-gsee-i-elliniki-ikonomia-ke-i-apascholisi/. Accessed November 15, 2020.

 Google Scholar

Ministry of Labour, Social Insurance and Social Solidarity. ΦΕΚ 173/Β/30-1-2019, Υπoυργική Απόφαση Αριθμ. oικ. 4241/127/2019 [Government Gazette Issue 173/Β/30-1-2019, Ministerial Decision 4241/127/2019];. Athens: National Printing Office; Available from http://www.et.gr/idocs-nph/search/pdfViewerForm.html?args=5C7QrtC22wFqnM3eAbJzrXdtvSoClrL8LHF9k8yiZ3t5MXD0LzQTLf7MGgcO23N88knBzLCmTXKaO6fpVZ6Lx3UnKl3nP8NxdnJ5r9cmWyJWelDvWS_18kAEhATUkJb0x1LIdQ163nV9K–td6SIuf2F2zpv5lDUhp0ASkQZV75FWh666bqpExbOic1jRo33.Accessed March 22, 2021.

 Google Scholar

Ministry of Finance, Ministry of Health. ΦΕΚ 4898/Β/1-11-2018, Απόφαση Αριθμ. ΕΑΛΕ/Γ.Π. 80157 [Government Gazette Issue 4898/Β/1-11-2018, Joint Ministerial Decision ΕΑΛΕ/Γ.Π. 80157]. Athens: National Printing Office. Available from https://eopyy.gov.gr/Files/%CE%A6%CE%95%CE%9A%204898%20%CF%84%20%CE%92%202018%20-%20%CE%9D%CE%95%CE%9F%CE%A3%20%CE%95.%CE%9A.%CE%A0.%CE%A5%2001%2011%202018.pdf. Accessed March 22, 2021.

 Google Scholar