Ventilation systems in operating rooms

a health technology assessment Summary

Health Technology Assessment 2011; 13(3)

2011

Ventilation systems in operating rooms a health technology assessment; Summary National Board of Health, Danish Centre of Health Technology Assessment URL: http://www.dacehta.dk Key words: health technology assessment, HTA, evidence, LAF, laminar airflow, conventional ventilation, TAF, turbulent airflow, ventilation, ventilation systems, infection, construction of hospitals, operating room, operation, knee, hips, orthopaedic surgery, risk surgery Language: English summary of the full report in Danish Format: pdf Version: 1.0 Version date: May 30 2011 Issued by: National Board of Health, Denmark, June 2011 Category: Advisory Design of report template: National Board of Health and 1508 A/S Layout of the report: Rosendahls-Schultz Grafisk A/S Design and layout of front page: Wright Grafics Electronic ISSN: 1399-2481 This report should be cited as follows: National Board of Health Ventilation systems in operating rooms a health technology assessment Copenhagen: National Board of Health, Danish Centre of Health Technology Assessment, 2011 Health Technology Assessment 2011; 13(3)

Series title: Health Technology Assessment Series editorial board: Mogens Hrder, Mickael Bech & Stig Ejdrup Andersen

For further information please contact: National Board of Health Danish Centre of Health Technology Assessment (DACEHTA) Islands Brygge 67 DK-2300 Copenhagen Denmark Phone: +45 72 22 74 00 E-mail: dacehta@sst.dk Home page: www.dacehta.dk The English summary can be downloaded at www.dacehta.dk

What is Health Technology Assessment?

Health technology assessment contributes to decision making in the health care sector. A HTA collects and assess existing knowledge about a given health technology. A health technology is defined broadly as procedures and methods for prevention, diagnostics, treatment, care and rehabilitation including devices and medicine. An example could be a new method to treat patients. Focus is on healthcare, patient, organisational and economical aspects. New research can be conducted if the number of sufficient studies is limited to elucidate one or more of these aspects. This report only has focus on the healthcare and economical aspects. The HTA results in a report that can contribute to better planning, quality enhancement and prioritizing in the health care sector. The target group is decision-makers in the health political field. The primary users are therefore administrations and politicians and other decision-makers in the health political field. HTA contributes to decisions within administration as well as political management as to which services should be offered in the health care sector and how they should be organized. Health technology assessment is defined as:

HTA is a comprehensive systematic assessment of the prerequisites and consequences of applying a health technology HTA is a research-based, application-oriented assessment of relevant existing knowledge about problem areas applying a technology within the field of health and illness.

HTA-reports are prepared in collaboration with an external interdisciplinary project group. The project group systematically reviews the existing literature, contributes with data collection and produces the chapters and conclusions of the report. The project management is placed at the National Board of Health who is also responsible for the editing of the final report. The report has been submitted to an external reference group. Find more information about HTA at www.sst.dk/mtv under HTA toolbox: Handbook of Methods for Health Technology Assessment Health Technology Assessment Why? What? When? How?

Ventilation systems in operating rooms a health technology assessment

Summary
Introduction
Surgery to insert prosthetic joints or other types of implants is considered to pose a high risk of infection. Deep infection in the tissue under the outer layers of the skin typically extends to the inserted implant and requires revision surgery. Deep infection thereby poses a health burden for patients and a considerable economic burden for society. Postoperative infection results from many diverse causes or conditions in and around patients. Each of these may be an individual risk factor for infection that varies in intensity for each person. Examples include the type of surgery, the patients immune status and the use of antibiotics. The presence of microorganisms is necessary but not sufficient to develop infection. This report focuses on one risk factor for infection: the purity of the air in the surgical field. National and international standards specify that orthopaedic surgical procedures that pose a high risk of infection should take place in ultraclean air in the surgical field, defined as less than or equal to 10 microorganisms (such as bacteria) per cubic metre of air. Ventilation systems in operating rooms are designed to control this risk factor, and operating rooms use two different ventilation principles. One principle is conventional mixing ventilation based on diffuse and turbulent streams of filtered air with the aim of creating mixed ventilation in the whole operating room. The other principle attempts to avoid turbulence and instead strives to precisely direct a linear stream of filtered air to the surgical field. The air streams move in parallel layers with identical speed: laminar air flow. This attempts to divide the air in the room into zones in which the air pressure of the centrally located streams of ultraclean air over the patient prevents the inward flow of the surrounding and less clean mixed air from the rest of the room. The purpose of the report is to produce an overview of the effectiveness of these two ventilation principles in preventing infection and the economics of these ventilation systems with the aim of contributing to the basis for making future investment decisions in Denmarks health care system.

Technology
The published health literature describing the use of these two ventilation principles and how effective they are in preventing infection was systematically reviewed. The review was limited to orthopaedic surgery procedures that pose a high risk of infection with the insertion of large foreign objects such as hip and knee prostheses. The literature was identified through a systematic search process, and the quality of the evidence was assessed based on internationally recognized standards. Three independent experts assessed the scientific articles reviewed.

Ventilation systems in operating rooms a health technology assessment

The conclusions of the report express the consensus of the experts on the design, results and quality of the evidence of each article. This consensus is based on checklists, evidence tables and an overall assessment of the quality of the evidence. The chapter of the report on technology reviews the literature regarding three key questions. 1. Is there evidence indicating that ventilation systems using turbulent air flow differ from those using laminar air flow in the incidence of infection after surgery? 2. Is there evidence indicating that ventilation systems using turbulent air flow differ from those using laminar air flow in their ability to produce ultraclean air in the surgical field? 3. Is there evidence indicating that the presence of ultraclean air versus less pure air in the surgical field is associated with the incidence of infection after surgery? The assessment of the literature in the report found the following. 1. Based on all the large and well-executed cohort studies reviewed, the report concludes that inserting joint prostheses in laminar air flow ventilation does not lead to a lower frequency of infection than in turbulent air flow ventilation. Each study individually provides moderate evidence, and well-executed randomized controlled trials in this field are lacking. Moderate evidence indicates that the initial insertion of a hip prosthesis is associated with unchanged or greater incidence of infection if this is carried out using laminar air flow versus turbulent air flow ventilation.

2. Moderate evidence indicates that both laminar air flow and turbulent air flow ventilation can be designed to produce ultraclean air with a concentration of microorganisms complying with the recommended limit value. Nevertheless, moderate evidence indicates that, using laminar air flow, the linear filtered air streams are perturbed by colliding with, for example, surgical lamps and people, and that this may result in increasing the number of bacteria-carrying particles in the surgical field. Moderate evidence indicates that using turbulent air flow ventilation can reduce the concentration of bacteria-carrying particles in the surgical field and that existing standards can be complied with by controlling the number of people in the room, optimizing the particle permeability of surgical gowns and by increasing the air circulation in the room.

3. A clinical study provides moderate evidence that ventilation with ultraclean air versus less pure air is not associated with the contamination of surgical wounds. No study has been found that can confirm any association between ventilation with ultraclean air versus less pure air and the incidence of deep infection after surgery.

Economics
The reports chapter on economics answers three key questions related to health technology assessment. 1. What is the costeffectiveness of laminar air flow versus turbulent air flow systems in operating rooms used for surgical procedures that pose a high risk of infection?

Ventilation systems in operating rooms a health technology assessment

2. What are the demonstrated costs for the capital investment and operating costs of laminar air flow and turbulent air flow systems? 3. How much does deep infection arising from surgical procedures that pose a high risk of infection cost Denmarks health care system? The report assesses the economics as follows. 1. No study was found in the literature on health economics that describes the cost effectiveness of various ventilation systems in operating rooms. 2. Laminar air flow systems are much more expensive in capital investment and maintenance than turbulent air flow systems. The marginal costs of laminar air flow systems versus turbulent air flow systems per operating room are estimated to be DKK1.5 million (200,000) in capital investment and about DKK30,000 (4000) in annual operating costs. The total annual marginal cost for laminar air flow systems is estimated to be DKK204,000 (27,400) per operating room. The national costs for laminar air flow systems in Denmarks health care system are estimated to be DKK187.5 million (25.2 million) in capital investment and DKK25.5 million (3.4 million) in annual costs, including the depreciation of the capital investment and operating costs.

3. The total annual costs of revision surgery for deep infection after hip and knee prosthesis surgery are estimated to be between DKK34.3 million (4.6 million) and DKK57.1 million (7.7 million).

Overall assessment
In connection with the future construction of hospitals planned in Denmark, it must be decided whether operating rooms used for surgery that poses a high risk of infection should be designed with ventilation systems based on turbulent air flow or laminar air flow. Laminar air flow systems are considerably more expensive in both capital investment and operating costs, and this type of ventilation does not lead to a lower incidence of infection for the insertion of joint prostheses versus conventional turbulent air flow systems. Surgery with laminar air flow systems even seems to be associated with an unchanged or increased incidence of infection in first-time hip replacement. This health technology assessment has similarly been unable to find evidence for any substantial difference in the incidence of deep infection according to whether the standard for ultraclean air is complied with or not; the standard stipulates a very low concentration of bacteria-carrying particles in the surgical field over the patient. No association has been demonstrated between ventilation with ultraclean air and the incidence of contamination of surgical wounds, but this does not mean that the purity of the air has no effect. It probably implies that the current limit value does not distinguish between the risk of developing infection and the uncertainty of whether infection will develop if the air is not ultraclean.

Ventilation systems in operating rooms a health technology assessment

The incidence of infection is linked to the interaction between numerous known and unknown risk factors external and internal to the patient. The purity of the air is just one of many such factors. It is widely accepted that risk factors such as intake of antibiotics, the use of particle-impermeable surgical gowns and the patients health status substantially influence the incidence of postoperative infection. Every future comparison between ventilation systems should ensure that these risk factors are controlled for in both trial groups. The scientific basis for decision-making in this field is currently based on database registration of numerous parameters. Well-executed randomized controlled trials are needed but difficult to carry out in this field. This report has not attempted to assess how the two types of ventilation systems affect the patients during surgery, including such factors as potential hypothermia and effects on blood clotting. The report has not assessed organizational aspects such as working environment factors related to temperature, surgical gowns, valves and closed-door policies or the amount of space in the operating room. No study has been identified in the literature that has focused on the differences in logistics and flexibility. The external framework and dependence on controlled air streams differ. Laminar air flow systems are assumed to place greater demands related to the absence of physical obstacles and movements in the air over the surgical field. The future prevention and monitoring of infection after implant surgery should focus on infection being an overall result of a varying number of potential causal factors. Such a focus will involve many other high-priority areas than the ability of ventilation systems to ensure ultraclean air.

Ventilation systems in operating rooms a health technology assessment

Projektgruppe
Eksterne projektdeltagere
Sundhedsstyrelsen vil gerne takke de eksterne projektgruppedeltagere for deres store arbejdsindsats. Projektgruppens habilitetserklringer er tilgngelige p Sundhedsstyrelsens hjemmeside. Frank Fars Nielsen (formand) Overlge, ph.d. Ortopdkirurgisk Afdeling E, rhus Universitetshospital Alma B. Pedersen Afdelingslge, ph.d. Klinisk Epidemiologisk Afdeling, rhus Universitetshospital Jens-Erik Varmarken Ledende overlge, klinisk lektor Ortopdkirurgisk Afdeling Sygehus Syd, Nstved Sygehus, Region Sjlland Lars Ehlers Professor, ph.d. i sundhedskonomi Aalborg Universitet

www.dacehta.dk

National Board of Health Dorte Gyrd-Hansen Forskningsleder, Dansk Sundhedsinstitut Health Documentation Professor, Syddansk Universitet og University of Queensland Danish Centre for Health Technology Assessment (DACEHTA) Islands Brygge 67 Hans-Ulrik Rasmussen 2300 Kbenhavn S Seniorprojektleder (indtil 31.oktober 2010) Tlf. 72 22 74 00 COWI A/S Projektleder (pr. 1. november 2010) dacehta@sst.dk Projektafdelingen for Det Nye Universitetshospital (DNU) www.dacehta.dk Figur 4-7 er tegnet af Anders Vandborg, civilingenir, COWI A/S

Projektdeltagere fra Sundhedsstyrelsen

Diana Reerman (projektleder) Akademisk medarbejder, cand.scient.san.publ.