BACKGROUND AND OBJECTIVES

Mouth retractors are essential in ensuring efficient yet safe exposure of the oral cavity and oropharynx. However, when applied improperly or haphazardly, retractors can cause tissue injuries and compromise patient safety. In addition, there are gaps in the usability of existing designs. This study aimed to identify the issues encountered by otorhinolaryngology surgeons in the use of commercially available mouth retractors, design and fabricate an improved retractor, and explore the use of additive manufacturing (popularly known as 3D printing) for retractor prototyping.

The study used the United States Food and Drug Administration (US FDA) Design Control as its framework. End-user requirements from otorhinolaryngologists were collected through key informant interviews. Results were organized into a Design Input template which was used to guide the design and development process. Prototype designs were iteratively created using computer-aided design software and 3D printing. Once design specifications were satisfied, a beta prototype was fabricated and given to another cohort of otorhinolaryngologists. The participants assessed the usability of the beta prototype. System Usability Scale (SUS) was used to quantify participant's feedback.

Five designs were created in the course of the study. The final prototype was fabricated using a Stereolithography (SLA) 3D printer. Several features were developed to address user requirements. The primary modification was to make the retractor modular to facilitate easier and shorter mounting and assembly. Gingival injury was addressed with the replacement of the maxillary alveolus hook with support bars. Five participants evaluated the beta prototype which received a mean SUS score of 75, well above the 50th percentile threshold.

This study demonstrates the applicability of the US FDA Design Control Process in the local setting to improve the mouth retractor design. Clinical and ergonomic issues were identified and design solutions were proposed and some have been implemented in a low-fidelity prototype. Results of the small-scale usability test suggest that the present form factor can be the basis for further iterations. Future studies can implement the proposed features to address other clinical and ergonomic needs.

This paper studies the necessity of the current legislation on the supervision of medical devices in China from the perspectives of strengthening administration according to law, protecting public health, perfecting the legal system of medicine and promoting the development of the medical device industry. This study analyzes and summarizes the legislative experiences and forms in the field of medical device regulation in the United States, the European Union, Japan and other countries and regions, at present, the conditions of carrying out the legislation of medical device supervision in China are quite mature, and some policy suggestions are put forward for the enactment of the law of medical device management in China.
Equipment and Supplies ; European Union ; Feasibility Studies ; Industry ; Medical Device Legislation ; United States ; United States Food and Drug Administration

The COVID-19 pandemic has had a major impact in healthcare systems across the world, with many hospitals having to come up with protocols and measures to contain the spread of the virus. This affects various specialties' clinical practices in many ways. Since early 2020 in Singapore, the Department of Otorhinolaryngology at Tan Tock Seng Hospital had to rapidly adapt to this pandemic as we provided services to the main healthcare facility combating the virus in our country. We had to design new workflows and also remain flexible in view of the ever-changing situation. There are 6 important domains for an otolaryngology department or any clinical department in general to consider when making adjustments to their practices in an outbreak: (1) clinical work, (2) education, (3) research, (4) safety of patients and staff, (5) morale of medical staff and (6) pandemic frontline work. We hope that the sharing of our experiences and the lessons learnt will be useful for both our local and international colleagues.
Ambulatory Care ; Biomedical Research ; COVID-19/prevention & control* ; Delivery of Health Care/methods* ; Education, Medical ; Elective Surgical Procedures ; Health Workforce ; Humans ; Morale ; Otolaryngology/methods* ; Otorhinolaryngologic Surgical Procedures ; Personal Protective Equipment ; Personnel Staffing and Scheduling ; SARS-CoV-2 ; Singapore/epidemiology* ; Workflow

In order to improve the efficiency of medical instrumentation management in hospital, reduce the management cost and save the human cost, this study analyzes the problems in the traditional hospital medical instrumentation management system, and develops a new system based on cloud computing. Through the characters of the SaaS Service Platform, the system improves the flow efficiency of the medical instrumentation in hospital, saves deployment and operating system costs, and improves the people's work efficiency.
Cloud Computing ; Durable Medical Equipment ; Materials Management, Hospital ; Software

Betacoronavirus ; Communication ; Coronavirus Infections ; epidemiology ; prevention & control ; therapy ; Disease Outbreaks ; Humans ; Medical Staff ; Pandemics ; prevention & control ; Patient Care Team ; Personal Protective Equipment ; Pneumonia, Viral ; epidemiology ; prevention & control ; therapy

OBJECTIVES: An automatic needle destroyer (ANDY) was developed to prevent needlestick injuries, and usability tests were conducted in several hospitals. The addition of extra features to the ANDY is in progress, such as data collection and automatic identification of used syringes. Thus, this report describes how the ANDY can be used to track the data of used syringes. METHODS: The motor torque required for barrel separation differs according to syringe diameters. By monitoring the electric current which is consumed for the motor torque, the type of syringe can be identified. Twelve prototypes were produced, and five usability tests were conducted in hospitals. RESULTS: After use, a syringe is inserted into the proposed device, and the needle portion is then cut and separated from the syringe body (barrel) and discarded. The needles are collected in a sharps container for hygienic disposal, and the barrel is dropped into a general medical waste container. CONCLUSIONS: The ANDY can be used to track the syringe used for each patient. The barcode can be read while the syringe rotates in the main body of the ANDY with a built-in omnidirectional scanner. Collection of information during syringe disposal can facilitate stock management. This system could also be extended to other types of consumable medical devices, although it would still be a challenge to differentiate each medical device.
Data Collection* ; Disposable Equipment ; Equipment and Supplies ; Equipment Design ; Humans ; Medical Waste ; Medical Waste Disposal ; Needles ; Needlestick Injuries ; Syringes* ; Torque

A thorough disinfection and infection control process associated with gastrointestinal endoscopy is highly important for the health and safety of the examinee and the medical staff involved in the procedure. Endoscopic reprocessing and disinfection are two of the most important steps in quality control of endoscopy. In 2019, the Korean Society of Gastrointestinal Endoscopy updated the Accreditation of Qualified Endoscopy Unit assessment items for these quality indicators. Assessment of disinfection and infection control comprises 28 mandatory items in the categories of disinfection education, pre-cleaning, cleaning, disinfection, rinsing, drying, reprocessing, storage, endoscopic accessories, water bottle and connectors, space/facilities, personal protective equipment, disinfection ledger, and regulations regarding infection control and disinfection. The updated Accreditation of Qualified Endoscopy Unit assessment items are useful for improving the quality of endoscopy by ensuring thorough inspection of endoscopic disinfection and infection control.
Accreditation ; Disinfection ; Education ; Endoscopy ; Endoscopy, Gastrointestinal ; Humans ; Infection Control ; Medical Staff ; Personal Protective Equipment ; Quality Control ; Social Control, Formal ; Water

Medical Device Single Audit Program is one of the key projects in International Medical Device Regulators Forum, which has much experience to be used for reference. This paper briefly describes the procedures and contents of the Witnessed Audit in Medical Device Single Audit Program. Some revelations about the work of Witnessed Audit have been discussed, for reference by the Regulatory Authorities and the Auditing Organizations.
Equipment and Supplies ; Medical Audit

The audit of the quality management system in the medical device single audit program covers the requirements of several national regulatory authorities, which has a very important reference value. This paper briefly described the procedures and contents of this audit. Some enlightenment on supervision and inspection are discussed in China, for reference by the regulatory authorities and auditing organizations.
China ; Equipment and Supplies ; Medical Audit ; Quality Control

Aerospace Medicine ; Emergencies ; Equipment and Supplies ; Ethics, Medical ; First Aid ; Humans ; Physicians ; Professional Competence ; Travel