[Fibrin sealants and hemostatic matrices in an intraoperative context]

Allard, B, Béland LC, Corbin D
Record ID 32018014014
French
Original Title: Colles de fibrine et matrices hémostatiques en contexte peropératoire
Authors' objectives: In Quebec, certain blood-derived products, such as fibrin sealants and hemostatic matrices, are used to manage bleeding and close incisions intraoperatively. To be distributed, these products must be added to the Liste des produits du système du sang du Québec (hereinafter referred to as the List) of the Ministère de la Santé et des Services sociaux (MSSS). Currently, the List includes 3 fibrin sealants and 2 hemostatic matrices. Two of these 5 products are not available. The 3 available products come from a single supplier, which exposes the supply chain to the risk of disruption. As part of a future market survey, the MSSS has mandated the INESSS to provide an overview of the use of fibrin sealants and hemostatic matrices in the intraoperative context, in order to better define the requirements for this type of product in the Quebec healthcare system.
Authors' results and conclusions: RESULTS (#1 DATA ON CLINICAL RELEVANCE): Data from 50 randomized controlled trials (RCTs) indicate that fibrin sealants and hemostatic matrices are generally more effective and faster than conventional methods in achieving hemostasis. Some studies indicate that they are also more effective than conventional methods for graft adhesion and reducing leakage of biological fluids. (#2 INTRAOPERATIVE USE OF FIBRIN SEALANTS AND HEMOSTATIC MATRICES IN QUEBEC): To meet the heterogeneous medical needs for hemostasis, impermeabilization and tissue adhesion encountered in their practice, clinicians stress the importance of having access to a diversified range of products, including sealants and matrices. In their view, each product has its own application niche. Currently, the clinicians consulted feel that the medical needs are adequately met by the range of products available in their practice. (#3 CONSIDERATIONS ASSOCIATED WITH THE USE OF COMMERCIAL PREPARATIONS OF FIBRIN SEALANTS AND HEMOSTATIC MATRICES): The use of fibrin sealants in the intraoperative setting is associated with several organizational considerations. These may act as barriers or facilitators to their accessibility and use. Most clinicians consulted feel that training, obtaining consent and preparing fibrin sealants and hemostatic matrices do not restrict the use of these products. (#4 ECONOMIC ASPECTS): The economic literature indicates that there is no established link between the costs of surgical supplies used and the expected benefits for the patient. Moreover, clinicians' greater awareness of costs would make them more attentive to the use of resources, resulting in reduced expenditure. Fluctuations in these costs would be mainly attributable to clinicians' preferences and experience, highlighting the importance of judicious use of fibrin sealants. (#5 CONSIDERATIONS FOR FUTURE MARKET SOLICITATION): According to the clinicians consulted, access to a variety of sealants and matrices is necessary to meet the medical needs of hemostasis, tissue adhesion and impermeabilization in the intraoperative context. These products would be neither interchangeable with each other nor with other hemostatic agents and tissue adhesives, making them essential to address certain situations encountered in practice. CONCLUSION: Considering the risks in the event of shortages and the additional costs associated with sourcing from a single supplier, as well as the need for a diversified product offering and the non-interchangeability of sealants and matrices in clinical practice, it would be conceivable to extend a future market solicitation to other suppliers of fibrin sealants and hemostatic matrix.
Authors' methods: A rapid review of the scientific literature was conducted to answer the assessment questions, based on publications listed in bibliographic databases and other sources of information. An economic analysis based on Héma-Québec volumetric data and the price of listed fibrin sealants and hemostatic matrices was also conducted. In addition, an Advisory Committee made up of 14 clinicians from various surgical specialties addressed the assessment issues.
Details
Project Status: Completed
Year Published: 2025
English language abstract: An English language summary is available
Publication Type: Other
Country: Canada
Province: Quebec
MeSH Terms
  • Fibrin Tissue Adhesive
  • Hemostasis, Surgical
  • Hemostatics
Contact
Organisation Name: Institut national d'excellence en sante et en services sociaux
Contact Address: L'Institut national d'excellence en sante et en services sociaux (INESSS) , 2021, avenue Union, bureau 10.083, Montreal, Quebec, Canada, H3A 2S9;Tel: 1+514-873-2563, Fax: 1+514-873-1369
Contact Name: demande@inesss.qc.ca
Contact Email: demande@inesss.qc.ca
Copyright: L'Institut national d'excellence en sante et en services sociaux (INESSS)
This is a bibliographic record of a published health technology assessment from a member of INAHTA or other HTA producer. No evaluation of the quality of this assessment has been made for the HTA database.