This article presents the mapping of horizons scanning systems (HSS) for medical devices, conducted by the Medical Devices Working Group of the International Horizon Scanning Initiative (IHSI MDWG). It provides an overview of the identified HSS, highlights similarities and differences between the systems, and lessons learned.

Potentially relevant HSS were identified through literature searches, scan of an overview of EuroScan members, and input from the IHSI MDWG members. Structured information was collected from organizations that confirmed having an HSS for medical devices.

Sixteen initiatives could be identified, of which 11 are currently ongoing. The purposes of the HSS range from raising awareness of trends and new developments to managing informed decisions on innovative health services in hospitals. The time-horizon is most often 3 years up to a few months before market entry. Three models of identification of new technologies crystallized: a reactive (stakeholders outside HSS inform), a pro-active (actively searching multifold sources), and a hybrid model. Prioritization is often conducted by separate committees via scoring or debate. The outputs focus either on in-depth information of single technologies or on a class of technologies or on technologies in specific disease areas.

The identified HSS share the common experience that horizon scanning (HS) for medical devices is a resource-intensive exercise that requires a dedicated and skilled team. Insights into the identified HSS and their experiences will be used in the continued work of the IHSI MDWG on its proposal for an IHSI HSS for medical devices.

Health technology assessments (HTAs) have traditionally included clinical and cost-effectiveness evaluation of new health technologies (HTs). However, new HTs can generate important organizational impacts (OIs) that influence their overall value. OIs are currently not clearly identified and evaluated in HTA procedures and tools are limited. To address this issue, a comprehensive framework that allows to assess OIs of new HTs in HTAs is proposed.

A working and methodological group identified the Oslo Manual 2018, 4th edition, OECD/Eurostat, on the objectives and outcomes of commercial innovations as the basis for the OIs framework for HTAs. The Oslo Manual was translated to the healthcare sector and adapted to HTA procedures through a three-step process.

The framework is composed of three main parts. Part I tackles the context of the evaluation, Part II the categories of impacts and the specific impacts – in total, 16 OIs were identified – and Part III the stakeholders involved. The central part of the framework is Part II, and consists of three categories of impacts: (i) on the care process, (ii) on the stakeholders’ capabilities and skills, and (iii) on society or the community.

This framework provides a comprehensive and structured basis to document OIs of new HTs. It thus contributes to the extension of HTA evaluation criteria to other dimensions than clinical and economic aspects, that is, organizational aspects. Some of its intrinsic limitations and the questions they raise in the field for policy-makers, practitioners, and researchers are discussed.

The French health technology assessment (HTA) agency initiated a research between 2018 and 2019 with the aim of determining whether other HTA organizations (agencies, bodies, institutes, and expert networks) and researchers had developed an evaluation framework of organizational impacts (OIs).

Three types of investigation were carried out: (i) an analysis of documents published by selected HTA organizations, (ii) a rapid review on the OI issues, (iii) a questionnaire survey to experts of the International Network of Agencies for Health Technology Assessment.

The analyses highlight six key points: (i) there is no explicit conceptual definition of OIs; (ii) OIs are often not included in a specific dimension of the evaluation or in the same dimensions; (iii) three recurring categories emerge from the assessment of OIs: processes, structure, and culture; (iv) despite its limitations, the European Network for Health Technology Assessment framework (Core Model) is the most mature assessment model to date; (v) the question of the scope of OIs to be considered is unresolved (micro-meso-macro); and (vi) the delineation between OI assessment and economic assessment must be addressed.

Although the issue of considering OI in HTA has been raised for many years, it remains largely unresolved. Defining the concept of OI is a prerequisite for taking the next step toward an evaluation framework. As the question of the impact of innovation goes beyond the health sector, extensive research on how to define and take into account these OIs may be relevant.

Medical equipment can transmit pathogenic bacteria to patients. This single-institution point prevalence study aimed to characterise the types and relative amount of bacteria found on surgical loupes, headlights and their battery packs.

Surgical loupes, headlights and battery packs of 16 otolaryngology staff and residents were sampled, cultured and quantified. Plate scores were summed for each equipment type, and the total was divided by the number of users to generate mean bacterial burden scores. Residents completed a questionnaire regarding their equipment cleaning practices.

The contamination rates of loupes, headlights and battery packs were 68.75 per cent, 100 per cent and 75 per cent, respectively. Battery packs cultured more bacteria (1.58 per swab ± 1.00) than loupes (0.75 per swab ± 0.66; p = 0.024). Headlights had non-significantly greater growth (1.50 per swab ± 0.71) than loupes (p = 0.052). Bacterial growth was significantly higher from inner surfaces of loupes (p = 0.035) and headlights (p = 0.037). Potentially pathogenic bacteria were cultured from the equipment of five participants, including: Pantoea agglomerans, Acinetobacter radioresistens, Staphylococcus aureus, Acinetobacter calcoaceticus baumannii complex and Moraxella osloensis.

This study demonstrates that surgical loupes and headlights used in otolaryngology harbour non-pathogenic skin flora and potentially pathogenic bacteria.

Unlike for intensive care unit and home mechanical ventilators, no study has evaluated the user-friendliness of the recently introduced new anaesthesia workstations.

We performed a prospective study to evaluate the user-friendliness of four anaesthesia workstations, which were categorized into two groups: first-generation (Kion) and second-generation (Avance, Felix and Primus). Twenty users (12 nurse-anaesthetists and 8 anaesthesiologists) from three different anaesthesia departments at the same univeristy hospital participated in the study. The user-friendliness scale evaluated 10 criteria, including two design and monitoring criteria, four maintenance criteria and four ventilation use criteria. Each criterion was evaluated from 0 (poor) to 10 (excellent).

The mean score obtained for the first-generation workstation was lower than those obtained for the three second-generation workstations (P < 0.05). No significant differences in the overall user-friendliness score was observed for the three second-generation workstations. The first-generation workstation obtained a significantly lower score than the three second-generation workstations for the design criteria (P < 0.01). For the screen criteria, the highest score was obtained by Felix, which has the largest screen and associated characters. For the main maintenance criteria, Kion and Felix obtained the lowest scores. No significant differences between the four anaesthesia workstations were found for only three of the user-friendliness criteria (self-test, alarms and settings).

Anaesthesia machines have benefited from considerable advances in design and technology. This novel user-friendliness scale revealed that the most recent workstations were more appreciated by users than the first-generation of anaesthesia workstations. This user-friendliness scale may help the anaesthetic staff to ‘consensually’ choose the future workstation for their anaesthesia department.

This study follows up an initial audit in 1992 indicating that anaesthetic machine checking practices were often incomplete. The aims were to ascertain if there has been any improvement during this period with special reference to the latest guidelines.

Following the Association of Anaesthetists of Great Britain and Ireland machine checking guidelines, a structured questionnaire, was used to interview 41 anaesthetists in the South West region on one particular day.

Despite 80% of subjects stating that they had read the latest guidelines recently, only one undertook a complete check and 39/41 (95%) performed partial checks (omitting one or more steps in the guidelines). Steps most commonly omitted were additional monitoring, ventilator function, availability of an alternative means of ventilation and function of ancillary equipment such as laryngoscopes. Only 5/41 subjects performed any check between cases. Several of these checks have been introduced in the 2004 guidelines.

Although there has been a significant increase in the proportion of anaesthetists undertaking machine checks since 1992 (P = 0.0007), we conclude that machine checking guidelines are still poorly followed, with checks specific to the latest guidelines most likely to be omitted.

The aim of this study was to determine which of two clinically applied methods, electromyography or acceleromyography, was less affected by external disturbances, had a higher sensitivity and which would provide the better input signal for closed loop control of muscle relaxation.

In 14 adult patients, anaesthesia was induced with intravenous opioids and propofol. The response of the thumb to ulnar nerve stimulation was recorded on the same arm. Mivacurium was used for neuromuscular blockade. Under stable conditions of relaxation, the infusion-rate was decreased and the effects of turning the hand were investigated.

Electromyography and acceleromyography both reflected the change of the infusion rate (P = 0.015 and P < 0.001, respectively). Electromyography was significantly less affected by the hand-turn (P = 0.008) than acceleromyography. While zero counts were detected with acceleromyography, electromyography could still detect at least one count in 51.1%.

Electromyography is more reliable for use in daily practice as it is less influenced by external disturbances than acceleromyography.

Inadvertent perioperative hypothermia causes serious morbidity in surgical patients. However, recent reports suggest that patients might still be hypothermic after elective surgery. We thus surveyed intraoperative temperature monitoring and management practices in Europe.

Postal survey of 801 representative hospitals from 17 European countries on the same day. The questions addressed the number of surgical procedures and type of anaesthesia performed, mode and site of temperature monitoring and method of patient warming. Mean and standard error of the mean or count and percentage were calculated. The t-test or contingency table analysis with the Fisher’s exact test were used.

Eight thousand and eighty-three surgical procedures were assessed from 316 responding hospitals (39.4%). Overall, patient temperature monitored in 19.4% and 38.5% of the patients were actively warmed. Under general anaesthesia, body temperature was monitored in 25% and during regional anaesthesia in 6%, P = 0.0005. Nasopharyngeal temperature was most often taken under general anaesthesia, while tympanic temperature was preferred during regional anaesthesia. Under general anaesthesia, 43% of patients were actively warmed as compared to 28% with regional anaesthesia, P = 0.0005. Forced-air warming was the method of choice for both general and regional anaesthesia.

Intraoperative temperature monitoring is still uncommon and hence active patient warming is not a standard of care in Europe. Awareness of perioperative hypothermia is critical to its prevention, and thus temperature monitoring is a pre-requisite. The objective is to maintain normothermia in patients throughout surgery. A European practice guideline for perioperative patient temperature management is warranted.

Significant start-up delays are inherent to syringe infusion pumps, particularly at low infusion rates, as routinely used in children’s anaesthesia and intensive care. Such delays are mainly the result of engagement of gears in the mechanical drive or compliance of the syringe assembly. The purpose of the present study was to determine the effect of flow rate, syringe size and syringe architecture on fluid delivery during infusion start-up.

Elapsed time from infusion start to achievement of steady-state flow was gravimetrically determined for various infusion rates (0.1, 0.5, 1 mL h−1), different syringe sizes (10-, 20-, 30-, 50-mL) and syringes of two different brands (BD and Codan). Four measurements for each condition were performed with two identical Alaris® Asena™ GH syringe infusion pumps (total of eight experiments). Statistical analysis was done by two-way ANOVA with Bonferroni’s post-test; P < 0.05 was considered significant.

Start-up time was from 3.6 ± 0.9 min (BD 10-mL syringe, 1.0 mL h−1) to 74.5 ± 26.6 min (BD 50-mL syringe, 0.1 mL h−1). Overall, the start-up time markedly increased with lower flow rate (0.1 mL h−1 vs. 1 mL h−1; P < 0.0001), larger syringe size (50 mL vs. 10 mL; P < 0.01), and the BD brand in comparison with the Codan syringes (P < 0.01).

Highest possible flow rate, smaller sized syringes and syringe plungers with reduced compressibility should be preferred in order to avoid significant start-up delays in fluid delivery.