Medical device reprocessing (MDR) in Alberta medical clinics: Patient safety risk warrants regulatory oversight

Background: Effective medical device reprocessing (MDR) is essential in preventing the spread of microorganisms and maintaining patient safety. Alberta Health Services (AHS) is an Alberta-wide, integrated health system, responsible for delivering health services to >4.3 million people living in the province. In 2010, periodic province-wide MDR reviews were initiated by the provincial health system to verify that the cleaning, disinfection, and sterilization of reusable critical and semicritical medical devices met established standards. To date, there have been 3 review cycles; in cycle 3, a follow-up process for tracking and reporting corrective actions was initiated. Methods: As in previous MDR review cycles, cycle 3 included the use of a standardized suite of tools to measure compliance with standards set by Accreditation Canada, the Canadian Standards Association, and the Government of Alberta. Each cycle involved a review of MDR areas completed by trained reviewers. Interrater reliability among reviewers was maintained through training and debriefings following reviews to ensure agreement. Following reviews, reports were generated for areas, zones, and AHS. As part of the corrective actions and follow-up process, identified deficiencies were categorized into 5 themes. Corrective actions were tracked and periodic reports were generated showing the progress of deficiency resolution. Resolution rates (number of resolved deficiencies divided by total number of of deficiencies) were calculated for each of the identified themes as well as overall for cycle 3. Results: Overall compliance for cycle 3 was 93%. Cycle 3 reviews revealed that more than half of the deficiencies (58%) were identified previously in cycle 2. The resolution rates ranged from 78% to 95% for identified deficiencies for 4 of the 5 themes: documentation, technique, PPE/attire/hand hygiene, and other. The theme related to physical infrastructure showed a considerably lower resolution rate of 49%. The corrective action follow-up process showed increased overall resolution rate from 59% at the start of the follow-up process to 82% at its completion. When this resolution rate was applied to the initial survey compliance rate for cycle 3, overall compliance increased to 99%. Conclusions: Monitoring quality of MDR practices is essential in maintaining and improving patient safety. The standardized provincial review process identified common themes and a coordinated approach to support the resolution of many identified deficiencies. Most of those deficiencies were resolved; however, those deficiencies related to physical infrastructure of the MDR department continue to be seen across review cycles. This review process with follow up of these deficiencies can help bring attention to organization leadership and Funding: authorities during budget cycles.Funding: NoneDisclosures: None

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Medical Device Regulation and the Proposed Therapeutic Products Bill: Devising a New Regime

Victoria University of Wellington Law Review ◽

10.26686/vuwlr.v52i2.7136 ◽

2021 ◽

Vol 52 (2) ◽

pp. 319-342

Author(s):

Laura Hardcastle

Keyword(s):

Patient Safety ◽

New Zealand ◽

Medical Devices ◽

Cosmetic Products ◽

Regulatory Oversight ◽

Speed To Market ◽

The Government ◽

The Right ◽

Promote Patient Safety ◽

Medical Device Regulation

Despite medical devices being integral to modern healthcare, New Zealand's regulation of them is decidedly limited, with repeated attempts at reform having been unsuccessful. With the Government now indicating that new therapeutic products legislation may be introduced before the end of the year, the article considers the case for change, including to promote patient safety, before analysing the draft Therapeutic Products Bill previously proposed by the Ministry of Health, and on which any new legislation is expected to be based. It concludes that, while the proposed Bill is a step in the right direction, introducing regulatory oversight where there is currently next to none, there is still significant work to be done. In particular, it identifies a need to clarify whether the regime is indeed to be principles-based and identifies further principles which might be considered for inclusion. It further proposes regulation of cosmetic products which operate similarly to medical devices to promote safety objectives, while finding a need for further analysis around the extent to which New Zealand approval processes should rely on overseas regulators. Finally, it argues that, in an area with such major repercussions for people's health, difficult decisions around how to develop a framework which balances safety with speed to market should not be left almost entirely to an as yet unknown regulator but, rather, more guidance from Parliament is needed.

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A Proposed Set of Metrics to Reduce Patient Safety Risk From Within the Anatomic Pathology Laboratory

Laboratory Medicine ◽

10.1093/labmed/lmw068 ◽

2017 ◽

Vol 48 (2) ◽

pp. 195-201 ◽

Cited By ~ 6

Author(s):

Peter Banks ◽

Richard Brown ◽

Alex Laslowski ◽

Yvonne Daniels ◽

Phil Branton ◽

...

Keyword(s):

Patient Safety ◽

Pathology Laboratory ◽

Safety Risk ◽

Anatomic Pathology

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Patient safety may be compromised if study conclusions are generalized to products that make similar claims but have no equivalent research evidence

Journal of Patient Safety and Risk Management ◽

10.1177/2516043518809235 ◽

2018 ◽

Vol 24 (1) ◽

pp. 37-45 ◽

Cited By ~ 3

Author(s):

Amit Gefen ◽

Nick Santamaria ◽

Sue Creehan ◽

Joyce Black

Keyword(s):

Patient Safety ◽

Medical Device ◽

Cost Benefit ◽

Well Being ◽

Product Selection ◽

Specific Product ◽

Medical Claims ◽

Published Evidence ◽

Pressure Injury ◽

Pressure Injury Prevention

This paper addresses a fundamentally important issue in health care, namely how to make informed decisions on product selection when two products, from different manufacturers, appear to be similar and have medical claims that sound comparable. In such cases, manufacturers of competing products often use each other’s evidence. They argue that the published evidence is generally applicable even if the original bioengineering tests and clinical trials were performed on a specific product, and no equivalence was obtained for their product that has similar medical claims. In this work, we use prophylactic dressings for pressure injury prevention as a good demonstrative example on how patient safety may be compromised if study conclusions are generally projected to such unstudied products. The medical device industry is regulated differently than the pharmaceutical industry, and consequently, voids in current medical device regulation are sometimes used to promote commercial interests. This paper analyzes gaps and potential pitfalls that occur where guiding documentations (e.g. guidelines, standards) do not cope well with medical technology. We explain how that can eventually lead to potential compromises to the well-being of patients, primarily if nurses are unaware of the aforementioned pitfalls. We conclude that currently, there is no alternative to rigorousness: Clinicians and decision-makers need to scrutinize up-to-date literature, decide which products have the best portfolio of bioengineering and clinical research to support the claims made, and which products have the best cost–benefit models. This is fundamentally different from simply buying the least expensive product because of appealing sale arguments.

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Are Regulations Safe? Reflections From Developing a Digital Cancer Decision-Support Tool

JCO Clinical Cancer Informatics ◽

10.1200/cci.20.00148 ◽

2021 ◽

pp. 353-363

Author(s):

Ciarán D. McInerney ◽

Beverly C. Scott ◽

Owen A. Johnson

Keyword(s):

Risk Assessment ◽

Primary Care ◽

Patient Safety ◽

Medical Device ◽

Assessment Tool ◽

Risk Assessment Tool ◽

Cancer Risk Assessment ◽

The European Union ◽

Standards And Regulations ◽

Fit For Purpose

PURPOSE Informatics solutions to early diagnosis of cancer in primary care are increasingly prevalent, but it is not clear whether existing and planned standards and regulations sufficiently address patients' safety nor whether these standards are fit for purpose. We use a patient safety perspective to reflect on the development of a computerized cancer risk assessment tool embedded within a UK primary care electronic health record system. METHODS We developed a computerized version of the CAncer Prevention in ExetER studies risk assessment tool, in compliance with the European Union's Medical Device Regulations. The process of building this tool afforded an opportunity to reflect on clinical concerns and whether current regulations for medical devices are fit for purpose. We identified concerns for patient safety and developed nine practical recommendations to mitigate these concerns. RESULTS We noted that medical device regulations (1) were initially created for hardware devices rather than software, (2) offer one-shot approval rather than supporting iterative innovation and learning, (3) are biased toward loss-transfer approaches that attempt to manage the fallout of harm instead of mitigating hazards becoming harmful, and (4) are biased toward known hazards, despite unknown hazards being an expected consequence of health care as a complex adaptive system. Our nine recommendations focus on embedding less-reductionist and stronger system perspectives into regulations and standards. CONCLUSION Our intention is to share our experience to support research-led collaborative development of health informatics solutions in cancer. We argue that regulations in the European Union do not sufficiently address the complexity of healthcare information systems with consequences for patient safety. Future standards and regulations should continue to follow a system-based approach to risk, safety, and accident avoidance.

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Nursing Turbulence in Critical Care: Relationships With Nursing Workload and Patient Safety

American Journal of Critical Care ◽

10.4037/ajcc2020180 ◽

2020 ◽

Vol 29 (3) ◽

pp. 182-191

Author(s):

Jennifer Browne ◽

Carrie Jo Braden

Keyword(s):

Critical Care ◽

Patient Safety ◽

Quality Of Care ◽

Full Range ◽

Operational Definition ◽

Nursing Workload ◽

Turbulence Scale ◽

Safety Risk ◽

Care Relationships

Background Increased nursing workload can be associated with decreased patient safety and quality of care. The associations between nursing workload, quality of care, and patient safety are not well understood. Objectives The concept of workload and its associated measures do not capture all nursing work activities, and tools used to assess healthy work environments do not identify these activities. The variable turbulence was created to capture nursing activities not represented by workload. The purpose of this research was to specify a definition and preliminary measure for turbulence. Methods A 2-phase exploratory sequential mixed-methods design was used to translate the proposed construct of turbulence into an operational definition and begin preliminary testing of a turbulence scale. Results A member survey of the American Association of Critical-Care Nurses resulted in the identification of 12 turbulence types. Turbulence was defined, and reliability of the turbulence scale was acceptable (α = .75). Turbulence was most strongly correlated with patient safety risk (r = 0.41, n = 293, P < .001). Workload had the weakest association with patient safety risk (r = 0.16, n = 294, P = .005). Conclusions Acknowledging the concepts of turbulence and workload separately best describes the full range of nursing demands. Improved measurement of nursing work is important to advance the science. A clearer understanding of nurses’ work will enhance our ability to target resources and improve patients’ outcomes.

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