An initial evaluation of the safety of a disposable oscillating positive expiratory pressure device in patients with chronic obstructive pulmonary disease: a sort-term pilot study.

BACKGROUND: Handheld oscillating positive expiratory pressure (OPEP) devices have been a mainstay of treatment for patients with hypersecretory conditions such as cystic fibrosis (CF) and chronic obstructive pulmonary disease (COPD) since the 1970s. Current devices are reusable and require regular cleaning and disinfection to prevent harbouring potentially pathogenic organisms. Adherence to cleaning regimens for respiratory devices is often poor and in response to this, a prototype disposable OPEP device-the 'UL-OPEP' (University of Limerick-Oscillating Positive Expiratory Pressure device)-was developed to mitigate the risk of contamination by pathogens. The device was previously evaluated successfully in a group of paediatric CF patients. The aim of the current study was to initially evaluate the safety of the prototype in patients with COPD over a period of 1 month to ensure no adverse events, negative impacts on lung function, exercise tolerance, or quality of life. Data on user experience of the device were also collected during post-study follow-up. METHODS: A sample of 50 volunteer participants were recruited from pulmonary rehabilitation clinics within the local hospital network. The patients were clinically stable, productive, and not current or previous users of OPEP devices. Participants were invited to use a prototype disposable OPEP device daily for a period of 1 month. Pre- and post-study lung function was assessed with standard spirometry, and exercise tolerance with the 6-min-walk-test (6MWT). Quality of life was assessed using the St. George's Respiratory Questionnaire (SGRQ), and user experience of the prototype device evaluated using a post-study questionnaire. RESULTS: 24 Participants completed the study: 9 were female. Overall median age was 67.5 years, range 53-85 years. Lung function, 6-min walk test, and SGRQ scores showed no significant change post-study. User feedback was positive overall. CONCLUSIONS: The results indicate that the UL-OPEP is safe to use in patients with COPD. No adverse events were recorded during the study or in the follow-up period of 2 weeks. The device did not negatively impact patients' lung function, exercise tolerance, or quality of life during short term use (1 month), and usability feedback received was generally positive. Larger, longer duration studies will be required to evaluate efficacy. Registration The study was approved as a Clinical Investigation by the Irish Health Products Regulatory Authority (CRN-2209025-CI0085).

Three-Dimensional Printed Devices for Health Care in Response to the Coronavirus Disease 2019: Lessons Learned to Date.

During the first surge of the coronavirus disease 2019 (COVID-19) there was a tremendous global response from three-dimensional (3D) printing communities and individuals to support local health care systems and staff. The responses involved a range of 3D printer users from amateur makers to conglomerate manufacturers creating personal protective equipment (PPE) and other supplies of which there were shortages. These new supply chains resulted from the democratization of 3D printing, open source file sharing, mass production of desktop machines, and the relatively cheap cost of 3D printers. The democratized state of 3D printing facilitated an altruistic movement of makers with ranging experience, to work alongside traditional manufacturers to make medical supplies. With the critical nature of the shortages and the sharp increase in COVID-19 infections, many standards and regulations were bypassed, and good manufacturing processes disregarded, in cases. The outcomes from this article is a set of six lessons learned from the authors perspective regarding the use of 3D printing during the initial phase of the COVID-19 pandemic. We note challenges experienced around volume manufacturing, infection control requirements of produced parts and the cleanability of devices, mechanical strength considerations, good manufacturing practices, product and intellectual property (IP) liability, and the role of involving clinical stakeholders.