Target product profiles for neonatal care devices: systematic development and outcomes with NEST360 and UNICEF.

BACKGROUND: Medical devices are critical to providing high-quality, hospital-based newborn care, yet many of these devices are unavailable in low- and middle-income countries (LMIC) and are not designed to be suitable for these settings. Target Product Profiles (TPPs) are often utilised at an early stage in the medical device development process to enable user-defined performance characteristics for a given setting. TPPs can also be applied to assess the profile and match of existing devices for a given context. METHODS: We developed initial TPPs for 15 newborn product categories for LMIC settings. A Delphi-like process was used to develop the TPPs. Respondents completed an online survey where they scored their level of agreement with each of the proposed performance characteristics for each of the 15 devices. Characteristics with < 75% agreement between respondents were discussed and voted on using Mentimeter™ at an in-person consensus meeting. FINDINGS: The TPP online survey was sent to 180 people, of which 103 responded (57%). The majority of respondents were implementers/clinicians (51%, 53/103), with 50% (52/103) from LMIC. Across the 15 TPPs, 403 (60%) of the 668 performance characteristics did not achieve > 75% agreement. Areas of disagreement were voted on by 69 participants at an in-person consensus meeting, with consensus achieved for 648 (97%) performance characteristics. Only 20 (3%) performance characteristics did not achieve consensus, most (15/20) relating to quality management systems. UNICEF published the 15 TPPs in April 2020, accompanied by a report detailing the online survey results and consensus meeting discussion, which has been viewed 7,039 times (as of January 2023). CONCLUSIONS: These 15 TPPs can inform developers and enable implementers to select neonatal care products for LMIC. Over 2,400 medical devices and diagnostics meeting these TPPs have been installed in 65 hospitals in Nigeria, Tanzania, Kenya, and Malawi through the NEST360 Alliance. Twenty-three medical devices identified and qualified by NEST360 meet nearly all performance characteristics across 11 of the 15 TPPs. Eight of the 23 qualified medical devices are available in the UNICEF Supply Catalogue. Some developers have adjusted their technologies to meet these TPPs. There is potential to adapt the TPP process beyond newborn care.

Decentralizing oxygen availability and use at primary care level for children under-five with severe pneumonia, at 12 Health Centers in Ethiopia: a pre-post non-experimental study.

BACKGROUND: Pneumonia is the leading infectious cause of death in children worldwide, accounting for 15% of all deaths in children under the age of five. Hypoxemia is a major cause of death in patients suffering from pneumonia. There is strong evidence that using pulse oximetry and having reliable oxygen sources in health care facilities can reduce deaths due to pneumonia by one-third. Despite its importance, hypoxemia is frequently overlooked in resource-constrained settings. Aside from the limited availability of pulse oximetry, evidence showed that healthcare workers did not use it as frequently to generate evidence-based decisions on the need for oxygen therapy. As a result, the goal of this study was to assess the availability of medical oxygen devices, operating manuals, guidelines, healthcare workers' knowledge, and skills in the practice of hypoxemia diagnosis and oxygen therapy in piloted health centers of Ethiopia. METHODS: A pre-post non-experimental study design was employed. An interviewer-administered questionnaire was used to collect primary data and review medical record charts. A chi-square test with a statistical significance level of P < 0.05 was used as a cut-off point for claiming statistical significance. RESULTS: Eighty one percent of healthcare workers received oxygen therapy training, up from 6% at baseline. As a result of the interventions, knowledge of pulse oximetry use and oxygen therapy provision, skills such as oxygen saturation and practices of oxygen therapy have significantly improved among healthcare workers in the piloted Health Centers. In terms of availability of oxygen devices (e.g. cylinders, concentrators, and pulse oximeters) in the facilities, seven (58%) facilities did not have any at baseline, but due to the interventions, all facilities were equipped with the oxygen devices. CONCLUSIONS: Given the prevalence of pneumonia and hypoxemia, a lack of access to oxygen delivery devices, as well as a lack of knowledge and skills among healthcare workers in the administration of oxygen therapy, may represent an important and reversible barrier to improving child survival. Therefore, scaling up clinician training, technical support, availability of oxygen devices, guidelines, manuals, strengthening maintenance schemes, and close monitoring of healthcare workers and health facilities is strongly advised.

Improved oxygen systems at hospitals in three Nigerian states: An implementation research study.

INTRODUCTION: Hypoxemia is a life-threatening condition and is commonly seen in children with severe pneumonia. A government-led, NGO-supported, multifaceted oxygen improvement program was implemented to increase access to oxygen therapy in 29 hospitals in Kaduna, Kano, and Niger states. The program installed pulse oximeters and oxygen concentrators, trained health care workers, and biomedical engineers (BMEs), and provided regular feedback to health care staff through quality improvement teams. OBJECTIVE: The aim of this study is to evaluate whether the program increased screening for hypoxemia with pulse oximetry and prescription of oxygen for patients with hypoxemia. METHODOLOGY: The study is an uncontrolled before-after interventional study implemented at the hospital level. Medical charts of patients under 5 admitted for pneumonia between January 2017 and August 2018 were reviewed and information on patient care was extracted using a standardized form. The preintervention period of this study was defined as 1 January to 31 October 2017 and the postintervention period as 1 February to 31 August 2018. The primary outcomes of the study were whether blood-oxygen saturation measurements (SpO2 ) were documented and whether children with hypoxemia were prescribed oxygen. RESULTS: A total of 3418 patient charts were reviewed (1601 during the preintervention period and 1817 during the postintervention period). There was a significant increase in the proportion of patients with SpO2 measurements after the interventions were conducted (adjusted odds ratio [aOR] 5.0; 4.3-5.7, P < .001). Before the interventions, only 13.7% (95% confidence interval [CI]: 12.2-15.3) of patients had SpO2 measurements and after the interventions, 82.4% (95% CI: 80.7-84.1) had SpO2 measurements. Oxygen administration for patients with clinical signs of hypoxemia also increased significantly (aOR 5.0; 4.2-5.9, P < .001)-from 22.8% (95% CI: 18.8-27.2) to 77.9% (95% CI: 73.9-81.5). CONCLUSION: Increasing pulse oximetry and oxygen therapy access and utilization in a low-resourced environment is achievable through a multifaceted program focused on strengthening government-owned systems.