dgkh000617
10.3205/dgkh000617
urn:nbn:de:0183-dgkh0006178
Review Article
Safety, cost and environmental impact of reprocessing low and moderate risk single-use medical devices: a systematic review
Sicherheit, Kosten und Umweltauswirkungen der Wiederaufbereitung von Medizinprodukten für den Einmalgebrauch mit geringem und mittlerem Risiko: eine systematische Übersicht
McGrath
McGrath
Niamh
N
Evidence Centre, Health Information and Evidence Directorate, Health Research Board, 67-72 Lower Mount St, Dublin, Ireland, D02 H638; Phone: +353 1 2345000Evidence Centre, Health Information and Evidence Directorate, Health Research Board, Dublin, Ireland
nmcgrath@hrb.ie
author
Waldron
Waldron
Catherine
C
Evidence Centre, Health Information and Evidence Directorate, Health Research Board, Dublin, Ireland
author
Farragher
Farragher
Ailish
A
Evidence Centre, Health Information and Evidence Directorate, Health Research Board, Dublin, Ireland
author
Teahan
Teahan
Áine
A
Evidence Centre, Health Information and Evidence Directorate, Health Research Board, Dublin, Ireland
author
Keshtkar
Keshtkar
Leila
L
Evidence Centre, Health Information and Evidence Directorate, Health Research Board, Dublin, Ireland
author
Polisena
Polisena
Julie
J
Health Technology Assessment Division, International Federation of Medical and Biomedical Engineering, Ottawa, Canada
author
Tessarolo
Tessarolo
Francesco
F
Department of Industrial Engineering, University of Trento, Trento, Italy
Healthcare Research and Innovation Program, Bruno Kessler Foundation, Trento, Italy
author
German Medical Science GMS Publishing House
Düsseldorf
610
reprocessing single-use devices class I
reprocessing single-use devices class II
endoscopic devices
laparoscopic devices
ophthalmic devices
surgical instruments
external fixators
stockings
compression sleeves
pulse oximeters
patient safety
costs
environmental impacts
Wiederaufbereitung single-use Medizinprodukte Klasse I
Wiederaufbereitung single-use Medizinprodukte Klasse II
laparoskopische Medizinprodukte
endoskopische Medizinprodukte
ophthalmologische Medizinprodukte
chirurgische Instrumente
externe Fixateure
Kompressionsstrümpfe
Kompressionsmanschetten
Pulsoximeter
Patientensicherheit
Kosten
Nachhaltigkeit
20260126
engl
This is an Open Access article distributed under the terms of the Creative Commons Attribution 4.0 License.
Dieser Artikel ist ein Open-Access-Artikel und steht unter den Lizenzbedingungen der Creative Commons Attribution 4.0 License (Namensnennung).
2196-5226
21
GMS Hygiene and Infection Control
GMS Hyg Infect Control
08
20260220Depiction of the correct license
Zielsetzung: Abschätzung der Sicherheit, finanzieller und Umweltauswirkungen der Wiederaufbereitung von Medizinprodukten für den Einmalgebrauch mit geringem und mittlerem Risiko (SuMDs).Methode: Systematische Überprüfung (PROSPERO ID: CRD42022365642) von Primärstudien über Patienten, die wiederaufbereitete SuMDs mit niedrigem und mittlerem Risiko (unkritisch und semikritisch a and b) erhalten haben, im Vergleich zur Erstverwendung von ansonsten identischen SuMDs. Die Artikel wurden über eine Datenbank- und Ergänzungssuche beschafft. Die Ergebnisse wurden nach Geräte-Risikoklasse angegeben, die Qualität der eingeschlossenen Studien wurde bewertet, und die primären Ergebnisse – direkte Patientensicherheit, direkte und indirekte finanzielle Kosten sowie Umweltauswirkungen - wurden nach einer narrativen Synthese nach dem GRADE-System (Grade of Recommendation, Assessment, Development and Evaluation) bewertet.Ergebnisse: Zehn Studien untersuchten 10 Produkte aus drei Kategorien der Risikoklasse I: externe Fixateure (n=3 Studien), Kompressionsmanschetten (n=2) und Pulsoximeter (n=1) und drei Kategorien von Produkten der Risikoklasse II: ophthalmologische Produkte (n=1), chirurgische Instrumente zum Greifen und Schneiden (n=1) und endoskopische und laparoskopische Produkte (n=5 Studien, 5 Produkte). Zwischen den beiden Produkttypen gab es keine signifikanten Unterschiede in der Wahrscheinlichkeit der primären Sicherheitsauswirkungen. Die einzige Studie, die Daten zu den primären finanziellen Auswirkungen beisteuerte, meldete keinen statistisch signifikanten Unterschied bei den Einsparungen zwischen neuen und wiederaufbereiteten Medizinprodukten. Die Wiederaufbereitung reduzierte die globale Erwärmung (n=2 Studien) und erhöhte die Auswirkungen auf die menschliche Gesundheit (n=1) bei allen vier Produkttypen. Die Evidenz in Bezug auf Sicherheit und Kosten war sehr gering.Schlussfolgerungen: Sofern die Wiederaufbereitung von SuMDs erlaubt ist, sind Sicherheitsüberwachungssysteme erforderlich. Die Wiederaufbereitungskosten sollten mit Hilfe geeigneter Methoden geschätzt werden, und es sind Forschungsarbeiten erforderlich, um sicherzustellen, dass Studien zur Lebenszyklusbewertung besser zur Entscheidungsfindung genutzt werden können.
Objectives: Estimate the safety, financial and environmental impacts of reprocessing low and moderate risk single-use medical devices (SuMDs). Methods: Systematic review (PROSPERO ID: CRD42022365642) of primary studies of patients receiving reprocessed low and moderate risk SuMDs (non-critical and semi-critical medical devices a and b) versus first use of otherwise identical SuMDs. Items were sourced via database and supplemental searching. Results were reported by device risk class, included studies were quality appraised, and primary outcomes: direct patient safety; direct and indirect financial costs; environmental impacts, were Grade of Recommendation, Assessment, Development and Evaluation (GRADE) assessed following narrative synthesis.Results: Ten studies examined 10 devices across three categories of risk class I devices: external fixator devices (n=3 studies), compression sleeves (n=2), and pulse oximeters (n=1) and three categories of risk class II devices: ophthalmic devices (n=1), surgical instruments for grasping and cutting (n=1) and endoscopic and laparoscopic devices (n=5 studies, 5 devices). There were no significant differences in the odds of primary safety outcomes across the two device types contributing data. The only study contributing primary financial impact data reported no statistically significant difference in savings for new versus reprocessed devices (p=0.340). Reprocessing reduced global warming (n=2 studies) and increased human health impacts (n=1) across the four device types contributing data. The certainty of safety and cost evidence was very low. Conclusions: Safety monitoring systems where SuMD reprocessing is permitted are required. Reprocessing costs should be estimated using appropriate methodologies and research is needed to ensure that life cycle assessment study designs can be better utilised to inform decision-making.
IntroductionSingle-use medical devices (SuMDs) are intended by their manufacturers to be used once and then discarded. In an effort to mitigate the costs and environmental footprint of health care, SuMDs reprocessing is practiced globally , , . Reprocessing, a process carried out on a used device to allow its safe reuse, involves cleaning, disinfection, sterilisation and related procedures, as well as testing and restoring the safety and performance of the used device . There are no requirements for manufacturers to prove that a device cannot be reprocessed and reprocessing industry stakeholders in Europe have estimated that 16% of devices labelled as being for “single-use” may technically be safe and effective to reprocess for a limited number of times . However, adverse events associated with reprocessing have been reported .Regulating SuMD reprocessing could reduce the risk of reprocessing related adverse events. Regulation likely reduces the volume of in-house (health facility) reprocessing due to the high cost and staff education and training implications of implementing regulatory standards . In turn, it may reduce the number of SuMDs reprocessed, as seen in Germany and Australia . Regulation may also inform the types of SuMDs reprocessed. For example, since 2000, the FDA has approved the reprocessing of over 100 SuMDs in the USA , with lower risk SuMDs (i.e. those which do not come into contact with the bloodstream or other sterile areas of the body), the most frequently reprocessed there . That regulated reprocessing reduces the volume of in-house reprocessing raises questions about the cost-effectiveness of SUMD reprocessing under regulated conditions. Generally, greater financial savings would be expected from high-risk devices compared to low and moderate risk devices as their more complex designs make them more expensive to produce . The European reprocessing industry and available systematic review evidence , are consistent in reporting that savings could differ by device. Potential saving estimates are frequently cited as 90% when reprocessing is undertaken at a health facility and 50% when reprocessing is undertaken by a third-party reprocessing company . To date, the scientific literature has been unable to confirm these estimates whereby available systematic reviews could not establish the cost-effectiveness of reusing SuMDs due to an inconclusive evidence base and a paucity of high-quality, appropriately designed studies , . Life cycle assessment studies, which examine the environmental impact of a medical device from its development to disposal, demonstrate that SuMDs typically result in higher petrochemical use and global greenhouse gas emissions compared with reusable alternatives , . However, it is not yet known whether reprocessing and reusing these SuMDs is more environmentally beneficial than their one-time use and subsequent disposal.
ObjectivesAs part of efforts to keep the EU Medical Device Regulation (MDR) legislative decision adopted by Ireland under review, the Health Research Board completed an evidence review requested by the Department of Health in Ireland on the safety, financial costs and environmental impacts of reprocessing SuMDs. The current article presents the findings of the systematic review of risk class I and risk class IIa and IIb devices. The aims of this review are to:Identify the risk class I and II SuMDs safe to reprocess in line with the 2017 EU medical device regulation and other related approaches, andSynthesise the safety, financial and environmental consequences of risk class I and II SuMDs reprocessing in line with the 2017 EU medical device regulation and other related approaches as well as any differences across SuMDs types.
MethodsReview designA systematic review was conducted and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) criteria , . Where appropriate, procedures were consistent with guidance on systematic reviews with cost and cost-e<![CDATA[ffectivene</PlainText></TextGroup>ss outcomes <TextLink reference="14"></TextLink>. The original study protoco<TextGroup><PlainText>l w</PlainText></TextGroup>as registered on the International Prospective R<TextGroup><PlainText>egister o</PlainText></TextGroup>f Systematic Reviews (PROSPERO) (ID: CRD42022365642). In this article, we present the results of human studies of risk class I and II SuMDs only. A report of risk class III devices has been published already <TextLink reference="15"></TextLink>.</Pgraph><SubHeadline>Literature search strategy</SubHeadline><Pgraph>We searched the following bibliographic databases from their inception: EMBASE, MEDLINE (Ovid platform), Dimensions, and the Cochrane Library. The peer-reviewed search strategy, using National Library of Medicine’s medical subject headings (MeSH), and keywords, centred on five concepts: single-use medical devices; reprocessing; safety and/or adverse outcomes; cost and cost-effectiveness; and environmental impacts. </Pgraph><Pgraph>Supplementary (i.e. reference and citation checking of included studies and relevant systematic reviews), and grey literature (i.e. government and regulatory authority websites; trial registers; Google.com and Google Scholar search engines [results 1–200] searches were also performed. </Pgraph><Pgraph>We limited the search to English and German language documents, owing to Germany’s experience in SuMDs reprocessing. Searches were undertaken between 2<TextGroup><PlainText>5 J</PlainText></TextGroup>uly and 23 September 2022 and updated in January 2024. The search strategy is available in Attachment 1 <AttachmentLink attachmentNo="1" />. </Pgraph><SubHeadline>Eligibility criteria</SubHeadline><Pgraph>The eligibility criteria were defined using the Population Intervention Comparison Outcomes Study design (PICOS) framework (Table 1 <ImgLink imgNo="1" imgType="table" />). SuMDs included devices and purpose-built components thereof exposed to human cells, bacteria and/or viruses. Reprocessing was defined using European legislation as “a process carried out on a used device in order to allow its safe reuse, including cleaning, disinfection, necessary sterilisation and related procedures, as well as testing and restoring the technical and functional safety of the used device” <TextLink reference="16"></TextLink>, with a similar definition employed in medical device research <TextLink reference="17"></TextLink>. To ensure health system comparability, primary studies of any healthcare facility using reprocessed SuMDs in Organisation for Economic Co-operation and Development (OECD) or EU member states only were eligible. Studies must have included at least one type of primary outcome of interest and compared outcomes with first use of the same SuMD. We did not include systematic review studies as we were uncertain that the evidence included in the reviews would reflect reprocessing as defined in our study <TextLink reference="7"></TextLink>, <TextLink reference="8"></TextLink>. </Pgraph><SubHeadline>Article selection</SubHeadline><Pgraph>Following deduplication in EndNote, two of three possible screeners (NMG, LK, CW) screened each item in EPPI Reviewer at title and abstract and again at full-text screening stages. Disagreements were resolved by consensus at both stages. Where individual study eligibility was unclear due to missing information at full text screening stage, study authors were contacted to seek clarification. If study authors did not respond within two weeks after the initial email, and one week after a reminder email, the study was excluded. </Pgraph><SubHeadline>Data extraction and outcome selection</SubHeadline><Pgraph>Study data were extracted independently by two of four reviewers (NMG, CW, LK, ÁT) into study design specific extraction forms in Microsoft Word and subsequently agreed by the two reviewers. Third-party arbitration was used to resolve disagreements. During extraction, devices were classified as risk class I, IIa or IIb, using Medical Device Coordination Group guidance <TextLink reference="18"></TextLink>. The system, created to support implementation of the 2017 EU Medical Device Regulation <TextLink reference="3"></TextLink>, <TextLink reference="16"></TextLink>, is similar to the Spaulding Classification System employed in the USA <TextLink reference="19"></TextLink> and considers more factors in the assignment of risk classes <TextLink reference="18"></TextLink>. </Pgraph><Pgraph>Safety and cost outcomes were selected for extraction by the review team based on their prevalence across device-specific studies, objective measurement, transparency of reporting, and cost sources (Attachment 2 <AttachmentLink attachmentNo="2" />). Primary outcomes were those which:</Pgraph><Pgraph><UnorderedList><ListItem level="1">Directly impacted patient safety (e.g. complications, functionality loss),</ListItem><ListItem level="1">accounted for both direct and indirect reprocessing costs (e.g. implementing reprocessing or due to infections), and</ListItem><ListItem level="1">directly adversely impact the environment (e.g. global warming potentials).</ListItem></UnorderedList></Pgraph><Pgraph>Secondary outcomes were those which:</Pgraph><Pgraph><UnorderedList><ListItem level="1">Indirectly impacted patient safety (e.g. procedure time),</ListItem><ListItem level="1">accounted for direct reprocessing costs only, and</ListItem><ListItem level="1">estimated environment-related human health impacts (e.g. toxicological effects of a process).</ListItem></UnorderedList></Pgraph><SubHeadline>Quality assessment</SubHeadline><Pgraph>Two reviewers independently assessed the quality of the studies included, with disagreements resolved by consensus. Adapted versions of the 27-item Downs and Black <TextLink reference="20"></TextLink> and 19-item Consensus Health Economic Criteria list (CHEC-list) <TextLink reference="21"></TextLink> were employed to quality appraise randomised and non-randomised studies and economic study designs. In the absence of a critical appraisal tool for life cycle assessment (LCA) study designs, we employed a transparency checklist proposed by Keil et al. <TextLink reference="22"></TextLink>. The checklist was based on German Institute for Standardization (Deutsches Institut für Normung; DIN) and International Organization for Standardization (ISO) standards DIN ISO 14040 and DIN ISO 14044. In keeping with the approach adopted by Keil et al., we report the proportion of items individual study authors report information on. Details of the adaptations made to the quality appraisal tools are reported in Attachment 3 <AttachmentLink attachmentNo="3" />.</Pgraph><SubHeadline>Data analysis and synthesis</SubHeadline><Pgraph>We completed an assessment of the feasibility of meta-analysis for each outcome following published guidance <TextLink reference="23"></TextLink>, <TextLink reference="24"></TextLink> (Attachment 4 <AttachmentLink attachmentNo="4" />). Based on the results, a narrative synthesis using structured reporting of effects was completed, calculating a standardised effect measure for safety outcomes; odds ratios for categorical outcomes and mean differences for continuous outcomes, and reporting of the number of observed events in the total population for categorical outcomes and the mean/median with standard deviations (SDs) for continuous outcomes <TextLink reference="24"></TextLink>. </Pgraph><SubHeadline>Grading of recommendations, assessment, development and evaluations</SubHeadline><Pgraph>The GRADE system was employed to determine a level of confidence, ranging from very low to high, in individual review outcomes based on the contributing primary studies <TextLink reference="25"></TextLink>. In line with best practice, we only applied GRADE assessments to primary review outcomes <TextLink reference="25"></TextLink>. We did not apply GRADE to environmental outcomes. </Pgraph></TextBlock>
<TextBlock name="Results" linked="yes">
<MainHeadline>Results</MainHeadline><SubHeadline>Search results and included studies</SubHeadline><Pgraph>Details of the search results and the PRISMA flow diagram are reported in Figure 1 <ImgLink imgNo="1" imgType="figure" />. We identified 10 studies <TextLink reference="26"></TextLink>, <TextLink reference="27"></TextLink>, <TextLink reference="28"></TextLink>, <TextLink reference="29"></TextLink>, <TextLink reference="30"></TextLink>, <TextLink reference="31"></TextLink>, <TextLink reference="32"></TextLink>, <TextLink reference="33"></TextLink>, <TextLink reference="34"></TextLink>, <TextLink reference="35"></TextLink> examining three types of risk class I device: external fixator devices (n=3 studies, 1 device) <TextLink reference="26"></TextLink>, <TextLink reference="27"></TextLink>, <TextLink reference="28"></TextLink>; compression sleeves (n=2 studies, 1 device) <TextLink reference="29"></TextLink>, <TextLink reference="30"></TextLink>; and pulse oximeters (n=1 study, 1 device) <TextLink reference="29"></TextLink>, and three types of risk class II device: ophthalmic devices (n=1 study, 1 device) <TextLink reference="31"></TextLink>; surgical instruments for grasping and cutting (n=1 study, 1 device) <TextLink reference="29"></TextLink>; and endoscopic and laparoscopic devices (n=5 studies, 5 devices) <TextLink reference="29"></TextLink>, <TextLink reference="32"></TextLink>, <TextLink reference="33"></TextLink>, <TextLink reference="34"></TextLink>, <TextLink reference="35"></TextLink>. </Pgraph><SubHeadline>Characteristics of included studies</SubHeadline><Pgraph>The characteristics of included studies are reported in Table 2 <ImgLink imgNo="2" imgType="table" />. The studies were undertaken in the USA (n=8) <TextLink reference="26"></TextLink>, <TextLink reference="27"></TextLink>, <TextLink reference="28"></TextLink>, <TextLink reference="29"></TextLink>, <TextLink reference="30"></TextLink>, <TextLink reference="31"></TextLink>, <TextLink reference="32"></TextLink>, <TextLink reference="34"></TextLink> and Europe (n=2; Portugal and Croatia) <TextLink reference="33"></TextLink>, <TextLink reference="35"></TextLink>. Study designs were classified as: randomised controlled trials (n=2 studies) <TextLink reference="28"></TextLink>, <TextLink reference="35"></TextLink>; observational (n=4 studies) <TextLink reference="26"></TextLink>, <TextLink reference="31"></TextLink>, <TextLink reference="32"></TextLink>, <TextLink reference="33"></TextLink>; costing (n=2 studies) <TextLink reference="27"></TextLink>, <TextLink reference="34"></TextLink>; and life cycle assessment (n=2 studies) <TextLink reference="29"></TextLink>, <TextLink reference="30"></TextLink>. </Pgraph><Pgraph>Safety outcome data were available for external fixator devices; ophthalmic devices; and endoscopic and laparoscopic devices. Cost outcomes were available for all device types, except for ophthalmic devices. Environmental outcomes were available for: compression sleeves; pulse oximeters; surgical instruments for grasping and cutting; and four endoscopic and laparoscopic devices. </Pgraph><Pgraph>Devices were reprocessed at hospital sterilisation departments in one (33%) external fixator device study <TextLink reference="26"></TextLink>, the (100%) ophthalmic device study <TextLink reference="31"></TextLink>, and two (20%) endoscopic and laparoscopic device studies (n=2 devices) <TextLink reference="34"></TextLink>, <TextLink reference="35"></TextLink>. Otherwise, reprocessing was undertaken by an external reprocessing company or the original device manufacturer. Most studies reported compliance with FDA reprocessing requirements (n=5 studies; 50%) and others followed local hospital or national policies (n=3 studies; 30%) or research team criteria (n=2 studies; 20%). The number of reprocessing cycles of the same device ranged from 1 <TextLink reference="32"></TextLink>, <TextLink reference="33"></TextLink>, <TextLink reference="35"></TextLink> to 9 <TextLink reference="34"></TextLink>.</Pgraph><SubHeadline>Safety outcomes</SubHeadline><Pgraph>Studies providing safety data were of poor/low to excellent quality based on the Downs and Black checklist (Table 2 <ImgLink imgNo="2" imgType="table" /> and Attachment 3 <AttachmentLink attachmentNo="3" />).</Pgraph><SubHeadline2>External fixator devices (risk class I)</SubHeadline2><Pgraph>No external fixator device safety outcomes were feasible for meta-analysis and were reported narratively (Attachment 4 <AttachmentLink attachmentNo="4" />; Table 3 <ImgLink imgNo="3" imgType="table" />). Dirschl and Smith put devices through up to two reprocessing cycles and reported the outcomes for the overall reuse programme only <TextLink reference="26"></TextLink>. The overlapping confidence intervals (CIs) indicated similar odds of infection between once-reprocessed devices and new SuMDs across studies (Table 3 <ImgLink imgNo="3" imgType="table" />). Sung et al. also reported no difference in the rate of loss of device fixation or loosening of device components between reused devices and new SuMDs <TextLink reference="28"></TextLink>. </Pgraph><SubHeadline2>Ophthalmic devices (risk class I)</SubHeadline2><Pgraph>One study contributing data on phaco needle tip reprocessing and reuse safety <TextLink reference="31"></TextLink> reported no intraoperative problems or postoperative complications attributable to phaco needle tips in the single-use or reused device groups. The authors reported that there was no association between phacoemulsification time and the number of device reuses (up to five uses), but did not report statistical data to support this statement <TextLink reference="31"></TextLink>.</Pgraph><SubHeadline2>Endoscopic and laparoscopic devices (risk class IIa)</SubHeadline2><Pgraph>Endoscopic and laparoscopic device safety outcomes were not feasible for meta-analysis due to inconsistent statistical outcome reporting and heterogeneity in author definitions of complication outcomes (Attachment 2 <AttachmentLink attachmentNo="2" />). Four outcomes: reoperations; post-operative complications, procedure time and duration of hospital stay were available for laparoscopic sealer/divider <TextLink reference="32"></TextLink>, ultrasonic scalpel/shears/scissors <TextLink reference="33"></TextLink>, <TextLink reference="35"></TextLink>, and linear suture machine <TextLink reference="33"></TextLink> devices. The odds of reoperations <TextLink reference="32"></TextLink>, reoperations and postoperative complications <TextLink reference="33"></TextLink>, and postoperative complications <TextLink reference="35"></TextLink> were consistently reduced in the reused group compared with the SuMD group, but differences did not reach statistical significance. There were no statistically significant differences in procedure time between procedures employing new and those employing once-reprocessed devices, but conflicting results were reported for duration of hospital stay (Table 3 <ImgLink imgNo="3" imgType="table" />).</Pgraph><SubHeadline>Cost outcomes</SubHeadline><Pgraph>Studies providing data on cost outcomes were of low to good quality or reported 68% of items on a transparency reporting checklist (Table 2 <ImgLink imgNo="2" imgType="table" /> and Attachment 3 <AttachmentLink attachmentNo="3" />). </Pgraph><SubHeadline2>External fixator devices (risk class I)</SubHeadline2><Pgraph>Two studies – Horwitz et al. <TextLink reference="27"></TextLink> and Sung et al. <TextLink reference="28"></TextLink> – reported on one direct cost outcome: savings incurred by the hospital during the study period. Both studies captured US dollar (US$) costs during a similar time frame (between 2001 and 2005) and assumed that a similar proportion (between 75% and 80%) of devices could pass reprocessing requirements. Horwitz et al. reported that reuse of reprocessed external components resulted in savings of 25% and savings of 21% when accounting for the cost of internal components of fixation devices <TextLink reference="27"></TextLink>. Sung et al. reported savings of 45% did not account for the device reuse rate <TextLink reference="28"></TextLink> (Table 3 <ImgLink imgNo="3" imgType="table" />). </Pgraph><SubHeadline2>Deep vein thrombosis compression sleeves (risk class I)</SubHeadline2><Pgraph>Of the seven devices examined in Unger and Landis’s study, deep vein thrombosis compression sleeves had the highest potential for device life cycle cost savings <TextLink reference="29"></TextLink> with incremental savings diminishing with each additional reprocessing cycle, up to five cycles (Table 3 <ImgLink imgNo="3" imgType="table" />). </Pgraph><SubHeadline2>Pulse oximeter (risk class I)</SubHeadline2><Pgraph>Pulse oximeter device reprocessing resulted in device life cycle cost savings with diminishing incremental savings with each additional reprocessing cycle, up to five cycles <TextLink reference="29"></TextLink> (Table 3 <ImgLink imgNo="3" imgType="table" />).</Pgraph><SubHeadline2>Surgical instruments for grasping and cutting (risk class IIa)</SubHeadline2><Pgraph>Arthroscopic shaver device reprocessing resulted in device life cycle cost savings with diminishing incremental savings after each reprocessing cycle <TextLink reference="29"></TextLink> (Table 3 <ImgLink imgNo="3" imgType="table" />).</Pgraph><SubHeadline2>Endoscopic and laparoscopic devices (risk class IIa)</SubHeadline2><Pgraph>Three of the four studies captured costs in US$ <TextLink reference="29"></TextLink>, <TextLink reference="32"></TextLink>, <TextLink reference="34"></TextLink>, and three studies estimated costs during a similar time frame (2013–2015) <TextLink reference="29"></TextLink>, <TextLink reference="32"></TextLink>, <TextLink reference="33"></TextLink>. Three studies examined direct, procedure-related costs <TextLink reference="32"></TextLink>, <TextLink reference="33"></TextLink>, <TextLink reference="34"></TextLink>. One study reported a significant decrease (US$282) in cost in the reprocessed compared with single-use group (<Mark2>p</Mark2>=0.028) <TextLink reference="32"></TextLink>. When accounting for both direct and indirect costs, savings were sustained but were no longer statistically significant (<Mark2>p</Mark2>=0.340) <TextLink reference="32"></TextLink>. Two studies reported annual hospital cost savings in the reprocessed group compared with the single-use group: US$65,961 when 222 devices were reused for an average of 2.4 times <TextLink reference="34"></TextLink>, €14,623.61 based on reuse of 193 linear suture machines compared with purchasing 178 new linear suture machines, and €75,932.55 based on reuse of 41<TextGroup><PlainText>8 u</PlainText></TextGroup>ltrasonic scalpel/shears/scissors and purchase of 285 new ultrasonic scalpel/shears/scissors over the study period <TextLink reference="33"></TextLink>. One study <TextLink reference="29"></TextLink> reported small incremental device life cycle related cost savings with each additional reprocessing cycle for each of the four endoscopic and laparoscopic device examined (Table 3 <ImgLink imgNo="3" imgType="table" />).</Pgraph><SubHeadline>Environmental outcomes</SubHeadline><Pgraph>Environmental impact outcome data were available across two studies for compression sleeve devices <TextLink reference="29"></TextLink>, <TextLink reference="30"></TextLink> and from one study for pulse oximeter, surgical instruments for grasping and cutting, and endoscopic and laparoscopic devices <TextLink reference="29"></TextLink>. The functional unit in the Lichtnegger et al. study <TextLink reference="30"></TextLink> was five uses of an intermittent pneumatic compression sleeve whereas, in the Unger and Landis report <TextLink reference="29"></TextLink>, it was annual use of seven single-use devices, used up to 5 times in a single hospital. Therefore, results are reported together across devices in the Under and Landis report. Both studies providing data on environmental outcomes <TextLink reference="29"></TextLink>, <TextLink reference="30"></TextLink> reported 68%–81% of items on a transparency reporting checklist (Table 2 <ImgLink imgNo="2" imgType="table" /> and Attachment 3 <AttachmentLink attachmentNo="3" />). </Pgraph><Pgraph>In their one-to-one device comparison (i.e. exclusion of annual device use), Unger and Landis <TextLink reference="29"></TextLink> reported the following relative global warming and human health outcomes: carcinogenic, non-carcinogenic and respiratory impacts. Of the devices studied, the compression sleeve had the highest global warming and non-carcinogenic impacts, and the laparoscopic sealer/divider had the highest carcinogenic and respiratory impacts <TextLink reference="29"></TextLink>. Device impacts, normalised to the device with the highest impact for each outcome, are reported in Table 4 <ImgLink imgNo="4" imgType="table" />. When accounting for annual use of all seven devices using median/mean reprocessing lifecycle inventory inputs, reprocessing resulted in a reduced and normalised global warming impact with each additional reprocessing cycle compared to single device use. When accounting for annual use of all seven devices using median/mean reprocessing lifecycle inventory inputs, reprocessing resulted in increased normalised carcinogenic, non-carcinogenic and respiratory impacts with each additional reprocessing cycle compared to single device use (Table 4 <ImgLink imgNo="4" imgType="table" />). In the study by Lichtnegger et al. <TextLink reference="30"></TextLink>, results related to the product contribution to ecological footprint of a person across the 4 impact domains. The authors reported reduced environmental contribution of the reused versus the new devices across all impact domains (Table 4 <ImgLink imgNo="4" imgType="table" />). They further quantified the reduction in global warming potential (kg CO2<Subscript>eq</Subscript>) of 7.0 for single use to 4.2 for treatment of five patients using reprocessed devices. </Pgraph><SubHeadline>Grading of recommendations, assessment, development and evaluations rating</SubHeadline><Pgraph>Eligible outcomes for the GRADE process were available for external fixator and endoscopic and laparoscopic devices. Specifically, the GRADE process was applied to four outcomes; pin tract infections (external fixator devices), reoperations (external fixator devices), post operative complications, including reoperations (endoscopic and laparoscopic devices) and total hospitalisation costs (endoscopic and laparoscopic devices). For all outcomes, the a priori rating was “low”, because most of the evidence for each of the four primary outcomes was derived from observational studies. Each outcome received at least one downgrade across two or more domains. When downgrades were applied, all outcomes received a final rating of very low certainty in the evidence. A summary table of judgements are provided in Table 5 <ImgLink imgNo="5" imgType="table" /> with explanations provided in Attachment 5 <AttachmentLink attachmentNo="5" />.</Pgraph><Pgraph> </Pgraph></TextBlock>
<TextBlock name="Discussion" linked="yes">
<MainHeadline>Discussion</MainHeadline><Pgraph>This study synthesises the available published evidence on SuMDs reprocessing across low and moderate risk devices, incorporating outcomes central to SuMD reprocessing debate (i.e. safety, economic and environmental considerations) <TextLink reference="1"></TextLink>, <TextLink reference="2"></TextLink>. We identified 10 SuMDs across six types of risk class I and risk class II devices. </Pgraph><Pgraph>Apart from divergent findings on differences in duration of hospital stay post-procedure, we found no additional adverse safety events following SuMD reprocessing. This finding aligns with the results of a 2008 FDA audit of reprocessing approved SuMDs which reported no additional adverse safety effects for external fixation devices, laparoscopic instruments, compression sleeves, pulse oximeters, and arthroscopic accessories <TextLink reference="5"></TextLink>. As with previous similar studies <TextLink reference="7"></TextLink>, <TextLink reference="8"></TextLink> we could not estimate the cost-effectiveness of SuMD reprocessing from the available data. Consistent with Hailey et al. <TextLink reference="8"></TextLink>, this report demonstrates that indirect costs of SuMD reprocessing significantly reduces cost savings. </Pgraph><Pgraph>Based on the results of the GRADE assessment, we have very low confidence that the results for primary review safety and cost outcomes would be replicated in future studies. There was some evidence of positive and negative environmental impacts of SuMDs reprocessing, and of different environmental impacts by device.</Pgraph><SubHeadline>Future research</SubHeadline><Pgraph>The results of this systematic review point toward a need for careful monitoring of the safety of risk class I and risk class IIa SuMDs reprocessing where the practice is permitted under legislation. </Pgraph><Pgraph>Furthermore, the findings underscore a need to estimate reprocessing costs using appropriate methodologies (e.g. economic evaluation studies), which is consistent with previous systematic reviews calling for additional cost-effectiveness research <TextLink reference="7"></TextLink>, <TextLink reference="8"></TextLink>, <TextLink reference="36"></TextLink>. Specifically, future primary evaluation studies should consider procurement costs, reprocessing costs, care delivery costs, reprocessing implementation costs, and potential differences in device reprocessing lifespan. For instance, neither of the included external fixator device studies accounted for indirect hospitalisation costs in spite of observed non-statistically significant increases in some adverse safety outcomes <TextLink reference="27"></TextLink>, <TextLink reference="28"></TextLink>. The high cost implications for health facilities of implementing regulatory SuMD reprocessing standards has also been noted <TextLink reference="2"></TextLink>. By making scientific and social value judgement more explicit, full economic evaluations enable accountability and transparency about the health care delivery choices made on behalf of others <TextLink reference="37"></TextLink>. As a result, full economic evaluation studies could assist EU member states in informing legislative options set out in the 2017 EU Medical Device Regulation, as well as other countries considering the question of SuMDs reprocessing. </Pgraph><Pgraph>To our knowledge, ours is the first systematic review to capture environmental impacts of SuMDs reprocessing. The results highlight areas for methodological development in life cycle assessment research applied to healthcare and health services evidence synthesis to best utilise them to inform decision-making. In 2021, McGinnis et al. <TextLink reference="38"></TextLink> described life cycle assessment studies applied to medical products and processes as <Mark2>“relatively new”</Mark2>. Specifically, available reporting checklists research should be validated, quality appraisal tools and reporting guidelines should be developed, as well as supports for applying the GRADE criteria to outcome data. In undertaking this methodological development work, life cycle assessment studies will be able to undergo all critical stages of a systematic review and will be more effective in informing decision-making in healthcare and health services research. </Pgraph><Pgraph>Finally, to best address ongoing debate in the field of SuMDs reprocessing, as well as adequately describing reprocessing oversight and processes, researchers should ensure that reprocessing safety and effectiveness studies are adequately powered to detect effects for primary and rare event outcomes e.g., major complications, which was lacking in several studies included in this review. Additionally, moving from observational to randomised controlled trials and adhering to relevant study design reporting standards would improve our confidence in the safety outcomes reported. When the proposed primary research is undertaken and reported as recommended, future systematic reviews on this topic could examine relationships between “reprocessing oversight” and safety, cost-effectiveness and environmental impacts. </Pgraph><SubHeadline>Strengths and limitations</SubHeadline><Pgraph>The strengths of this review are its broad focus and the rigorous methods employed. We attempt to consider the alignment of reprocessing with quality assurance standards in order to help contextualise similarities and differences in the findings between studies of similar risk SuMDs <TextLink reference="36"></TextLink>. By using a modern definition of reprocessing to determine study eligibility for inclusion, we were able to eliminate risks of including studies of similar related practices (e.g. sterilisation only). By distinguishing between the different “levels” of reprocessing oversight across studies, there was a potential to explore trade-offs between reprocessing safety and cost savings outcomes by reprocessing oversight. This distinction was useful as reprocessing regulation often requires outsourcing of reprocessing from hospital sterilisation departments to third-party reprocessors <TextLink reference="1"></TextLink>, <TextLink reference="2"></TextLink>. Conversely, it is possible that certain eligible items were excluded if they did not define “reprocessing” or report on the reprocessing procedures. Failure to report this information could add confusion to this topic and authors are encouraged to include these details in their studies. </Pgraph><Pgraph>To ensure adequate clinical knowledge of individual SuMDs, advice was sought from the Health Products Regulatory Authority (HPRA), Ireland’s regulatory body for health products, including medical devices. </Pgraph><Pgraph>Although standardising costs data to a single currency and for the current year to adjust for inflation is common in systematic reviews of economic studies <TextLink reference="14"></TextLink>, we felt that doing so would not result in comparable costs in this review due to the quality of the cost studies, the outcomes identified, the likely advances in technology, and regional differences in costs. Instead, the broader trend of the presence or absence of cost savings in individual studies comparing reused and once-used SuMDs was reported. </Pgraph></TextBlock>
<TextBlock name="Conclusion" linked="yes">
<MainHeadline>Conclusion</MainHeadline><Pgraph>Insufficient quality evidence to establish the safety, cost-effectiveness and environmental impacts of reprocessing risk class I and risk class II SuMDs persists. Reprocessing results in cost savings and reduced global warming impacts but marginal savings diminish with subsequent reprocessing cycles. The volume and type of available evidence differs by device type. There is a need for explicit monitoring of the safety of risk class I and risk class IIa SuMD reprocessing where the practice is permitted under legislation. Reprocessing costs should be estimated using appropriate methodologies, and research is needed to enable life cycle assessment study designs to go through all critical stages of a systematic review to best utilise them to inform decision-making. </Pgraph></TextBlock>
<TextBlock name="Notes" linked="yes">
<MainHeadline>Notes</MainHeadline><SubHeadline>Authors’ ORCIDs </SubHeadline><Pgraph><UnorderedList><ListItem level="1">McGrath N: <Hyperlink href="https://orcid.org/0000-0002-7716-7277">0000-0002-7716-7277</Hyperlink></ListItem><ListItem level="1">Waldron C: <Hyperlink href="https://orcid.org/0000-0002-0408-8543">0000-0002-0408-8543</Hyperlink></ListItem><ListItem level="1">Farragher A: <Hyperlink href="https://orcid.org/0009-0007-6338-2447">0009-0007-6338-2447</Hyperlink></ListItem><ListItem level="1">Teahan A: <Hyperlink href="https://orcid.org/0000-0002-4734-1457">0000-0002-4734-1457</Hyperlink></ListItem><ListItem level="1">Keshtkar A: <Hyperlink href="https://orcid.org/0000-0001-5249-3589">0000-0001-5249-3589</Hyperlink></ListItem><ListItem level="1">Tessarolo F: <Hyperlink href="https://orcid.org/0000-0003-4022-5602">0000-0003-4022-5602</Hyperlink></ListItem><ListItem level="1">Polisena J: <Hyperlink href="https://orcid.org/0000-0002-1560-3651">0000-0002-1560-3651</Hyperlink></ListItem></UnorderedList></Pgraph><SubHeadline>Source(s) of support</SubHeadline><Pgraph>This work was funded by the Health Research Board Evidence Centre, which is funded by the Department of Ireland, Ireland.</Pgraph><SubHeadline>Role of the funder/sponsor</SubHeadline><Pgraph>The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.</Pgraph><SubHeadline>Disclaimer </SubHeadline><Pgraph>Any views expressed in this report are those of the authors and not necessarily those of Ireland’s Minister for Health, Ireland’s Department of Health, the Health Research Board, the Bruno Kessler Foundation or the International Federation for Medical and Biological Engineering. The review authors have no competing interests to declare. </Pgraph><SubHeadline>Acknowledgements</SubHeadline><Pgraph>We extend our thanks to our colleagues at the Health Products Regulatory Authority, James McCarthy, Patrick Murphy, Dhanashree Gokhale, and Jennifer Roche, to Dr Karen McNamara at the Department of Health and to our Health Information and Quality Authority colleagues Dr Kieran Walsh and, formerly, Dr Paul Carty for their conceptual input during the design phase of this review. Several of our colleagues within the Health Research Board Evidence Centre also provided invaluable assistance with individual components of the review; specifically, Jean Long contributed to the review conception and early draft review and Dr Annette Burns who contributed to the GRADE assessment and data presentation. Finally, we thank peer reviewers who provided considered and valuable feedback on the full report, of which the present article forms a component of; Dr Lisa Leung, MRCP and Dr Mark Gallagher, MD FRCPI</Pgraph><SubHeadline>Competing interests</SubHeadline><Pgraph>The authors declare that they have no competing interests.</Pgraph></TextBlock>
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