Towards a common framework for defining ancillary material quality across the development spectrum.

Ancillary materials (AMs) play a critical role in the manufacture of cell and gene therapies, and best practices for their quality management are the subject of ongoing discussion. Given that the final product cannot be sterilized, AM quality becomes increasingly critical to the clinical advancement of cell and gene therapies. Despite a lack of direct legislative direction regarding AM quality, internationally harmonized guidance is available from several industry-standard bodies that describe the principles and application of a risk-based approach to AM qualification and related supply-chain risk management. According to a best-practice risk-based approach, AMs must be adequately qualified to a degree that reflects the level of risk the material presents to patient safety and the drug product's specification. This general approach can be implemented in different ways, and balancing quality with cost of goods is critical to the cost-effective manufacture of advanced therapy medicinal products. In some cases, it may be preferable or necessary to use AMs that are produced in compliance with current Good Manufacturing Practice. However, developers may be able to suppress manufacturing costs without undermining safety or regulatory compliance in the case that a material presents a lower risk profile. Despite a great deal of attention and interest in the quality of AMs in the cell and gene therapy space, there is still a need for greater harmonization to create a shared understanding of what constitutes a risk-based approach to AM production and sourcing. In this article, we propose a staged approach to AM quality that achieves a balance between the competing demands of risk mitigation and cost of goods containment at the various stages of AM quality development. Our novel, heuristic framework for communication among AM suppliers, users and regulators aims to bring down development and manufacturing costs and lessen the workload around regulatory compliance.

The Outcomes of a Comprehensive Program for Maintenance of Goldmann Applanation Tonometer.

PRECIS: We checked 190 tonometers every month and repaired faulty ones. Calibration error (CE) frequency reduced from 23% to 0.6% at 1 year. Tonometers needing one or >1 CE repair differed in survival but not in age. PURPOSE: The purpose of this study was to report the outcomes of a comprehensive program to maintain calibration status of the Goldmann applanation tonometer. METHODS: This prospective cohort study was carried out at 2 tertiary eye care referral centers. We included 190 slit-lamp mounted Goldmann applanation tonometers (Model AT 900 C/M). Health care providers (error checking and reporting) and clinical engineers (maintenance) participated. The team carried out CE check once a month, and repair of faulty tonometers, if any, within 24 hours. Failure of tonometer was defined as development of unacceptable CE beyond the third repair. The main outcome measures were the frequency of CE and survival function of the tonometer over 1 year. RESULTS: The median age of the tonometers was 10.7 (range, 0.2 to 25.1) years. The total number of repairs was 86. The proportion (95% confidence interval) of faulty tonometers reduced from 23.1% (17.7, 29.6) in the first month to 0.6% (0.1, 3.3) at 1 year (P<0.01). The median age of the tonometer did not differ between those needing (n=63, 9.4 y) and not needing (n=127, 10.7 y; P=0.24) repair. All tonometers requiring 1 CE repair (n=49, 25.7%) survived until 1 year. The survival of tonometers requiring >1 CE repair (n=14, 7.3%) was 40% at 1 year. CONCLUSIONS: Our in-house program maintained 92.6% tonometers error free. Number of repairs rather than age determined the need for replacement/sending back the tonometer to the manufacturer. Our simple and easy to follow maintenance program has the potential for wide application.

'Fit-for-purpose?' - challenges and opportunities for applications of blockchain technology in the future of healthcare.

Blockchain is a shared distributed digital ledger technology that can better facilitate data management, provenance and security, and has the potential to transform healthcare. Importantly, blockchain represents a data architecture, whose application goes far beyond Bitcoin - the cryptocurrency that relies on blockchain and has popularized the technology. In the health sector, blockchain is being aggressively explored by various stakeholders to optimize business processes, lower costs, improve patient outcomes, enhance compliance, and enable better use of healthcare-related data. However, critical in assessing whether blockchain can fulfill the hype of a technology characterized as 'revolutionary' and 'disruptive', is the need to ensure that blockchain design elements consider actual healthcare needs from the diverse perspectives of consumers, patients, providers, and regulators. In addition, answering the real needs of healthcare stakeholders, blockchain approaches must also be responsive to the unique challenges faced in healthcare compared to other sectors of the economy. In this sense, ensuring that a health blockchain is 'fit-for-purpose' is pivotal. This concept forms the basis for this article, where we share views from a multidisciplinary group of practitioners at the forefront of blockchain conceptualization, development, and deployment.

Inpatient toxicology services improve resource utilization for intoxicated patients: a systematic review.

AIMS: Presentations of intoxicated patients to hospital are frequent and increasing. We aimed to review the existing evidence that the presence of inpatient clinical toxicology services reduces use of resources without impacting on the care of these patients. METHODS: We conducted a literature search using the Cochrane Library, PubMed, and Embase for articles that measured length of stay (and other outcomes) for the target population, with toxicology services as an intervention. The articles were reviewed with respect to the ROBINS-I tool. RESULTS: Seven relevant articles were identified. Six of these studies demonstrated reduced hospital length of stay for intoxicated patients in hospitals with inpatient toxicology services. None of the articles demonstrated a detriment in morbidity or mortality. There were also improvements in other resource-related outcomes. CONCLUSIONS: The presence of inpatient toxicology services appears to improve resource utilization, in reduction of length of stay, as well as a number of other related outcomes. It does this without compromising on patient morbidity or mortality. Thus, it should be considered as a potential model of care for future toxicology services, especially with current trends of increasing demand for service efficiency.

Reducing cost and improving operating room efficiency: examination of surgical instrument processing.

BACKGROUND: Operating room efficiency can be compromised because of surgical instrument processing delays. We observed that many instruments in a standardized tray were not routinely used during thyroid and parathyroid surgery at our institution. Our objective was to create a streamlined instrument tray to optimize operative efficiency and cost. MATERIALS AND METHODS: Head and neck surgical instrument trays were evaluated by operating room team leaders. Instruments were identified as either necessary or unnecessary based on use during thyroidectomies and parathyroidectomies. The operating room preparation time, tray weights, number of trays, and number of instruments were recorded for the original and new surgical trays. Cost savings were calculated using estimated reprocessing cost of $0.51 per instrument. RESULTS: Three of 13 head and neck trays were converted to thyroidectomy and parathyroidectomy trays. The starting head and neck surgical set was reduced from two trays with 98 total instruments to one tray with 36 instruments. Tray weight decreased from 27 pounds to 10 pounds. Tray preparation time decreased from 8 min to 3 min. The new tray saved $31.62 ($49.98 to $18.36) per operation in reprocessing costs. Projected annual savings with hospitalwide implementation is over $28,000.00 for instrument processing alone. Unmeasured hospital savings include decreased instrument wear and replacement frequency, quicker operating room setup, and decreased decontamination costs. CONCLUSIONS: Optimizing surgical trays can reduce cost, physical strain, preparation time, decontamination time, and processing times, and streamlining trays is an effective strategy for hospitals to reduce costs and increase operating room efficiency.