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The implementation of an effective quality management system has always been considered a principal method for a manufacturer to maintain and improve its product and service quality. Globally many regulatory authorities incorporate quality management system as one of the mandatory requirements for the regulatory control of high-risk medical devices. The present study aims to analyze the GMP enforcement experience in Taiwan between 1998 and 2013. It describes the regulatory implementation of medical device GMP requirement and initiatives taken to assist small and medium-sized enterprises in compliance with the regulatory requirement. Based on statistical data collected by the competent authority and industry research institutes, the present paper reports the growth of Taiwan local medical device industry after the enforcement of GMP regulation. Transition in the production, technologies, and number of employees of Taiwan medical device industry between 1998 and 2013 provides the competent authorities around the world with an empirical foundation for further policy development. [ABSTRACT FROM AUTHOR]

Aim: To characterize resources to safely mobilize different types of hospitalized patients. Background: Current approaches to determine nurse–patient ratios do not always include information regarding the specific demands of patients who require extra resources to mobilize. Workflows must be designed with knowledge of resource requirements to integrate patient mobility into the daily nursing team care plan. Methods: Nurse‐led mobility sessions were evaluated on two adult hospital units, which consisted of nurse–patient encounters focused on patient mobility only. The resources assessed for each session were time‐to‐mobilize patient, time‐to‐document, need for additional staff support, and the need for assistive devices. Mobility sessions were also categorized by patient ambulation status, level of mobility limitations (low, medium and high) and diagnosis. Results: In 212 total mobility sessions, the median time‐to‐mobilize and time‐to‐document were 7.75 and 1.27 min, respectively. Additional staff support was required for 87% and 92% of patients with medium and high mobility limitations, respectively. All patients with low mobility limitations ambulated, and only 14% required additional staff. Ambulating patients with high mobility limitations was the most time‐intensive (median 12.55 min). Ambulating stroke patients required one additional staff and an assistive device in 92% and 69% of the sessions, respectively. Conclusion: This study describes the resources associated with mobilizing inpatients with different levels of mobility impairments and diagnoses. Implications for Nursing Management: These results could assist nursing management with facilitating appropriate daily nurse–patient ratios and justify the need for assistive devices and staff support to safely mobilize patients. [ABSTRACT FROM AUTHOR]

Background and Objective: Dispensing medicines into compliance aids is a common practice in pharmacy contrary to manufacturers’ advice and studies have shown the appearance of light-sensitive tablets is compromised by such storage; we previously found evidence of reduced bioavailability at elevated temperature and humidity. Our objective was to examine the physicochemical stability of two generic atenolol tablets in different compliance aids and with aspirin co-storage at room temperature and at 40 °C/75% relative humidity. Methods: The physicochemical stability of atenolol tablets was evaluated after 28 days of storage and compared with controls by examining visual appearance, weight, disintegration, dissolution, friability and hardness to accepted standards and using a previously validated HPLC method for chemical assay. Results and Discussion: The response to storage was brand-dependent and not straightforward. With one make of atenolol (Alpharma), storage in compliance aids even at room temperature impacted on physical stability, reducing tablet hardness, with storage in Dosett® exerting a greater impact than storage in Medidos® ( t-test P < 0·001). Co-storage at elevated temperature and humidity also impacted on the appearance of non-coated aspirin tablets (Angette™). The chemical stability of atenolol was not affected and we did not find evidence of changes to bioavailability with either make. Certainly data for one atenolol make (CP Pharmaceuticals) co-stored with aspirin (Angette™ and Nu-Seals) in both compliance aids at room temperature provided evidence of short-term stability. But medicines are dispensed into compliance aids in multi-factorial ways so our study highlights not only the lack of evidence but also a realization that evidence to support real practice may not be accomplished through research. Conclusion: Reassuring practitioners of the continued stability of medicines in compliance aids under the countless condition in which they are dispensed in practice may requires a different approach involving medical device regulators and more definitive professional guidance. [ABSTRACT FROM AUTHOR]