Evidence map›Paper›PMID 33764886›Full record

ReviewGlobal health, science and practice2021

The Evolving Landscape of Medical Device Regulation in East, Central, and Southern Africa.

Sarah Hubner, Caroline Maloney, Sarah Dunn Phillips, Pratik Doshi, Julius Mugaga, Robert Tamale Ssekitoleko, Jenna L Mueller, Tamara N Fitzgerald

Abstract readReview
In one paragraph

Review in Global health, science and practice, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Sarah HubnerTrinity College of Arts and Sciences, Duke University, Durham, NC, USA.
Caroline MaloneyTrinity College of Arts and Sciences, Duke University, Durham, NC, USA.
Sarah Dunn PhillipsMargolis Center for Health Policy, Duke University, Durham, NC, USA.
Pratik DoshiSchool of Medicine, Duke University, Durham, NC, USA.
Julius MugagaBiomedical Engineering Unit, Makerere University, Kampala, Uganda.
Robert Tamale SsekitolekoBiomedical Engineering Unit, Makerere University, Kampala, Uganda.
Jenna L MuellerClark School of Engineering, Duke University, Durham, NC, USA.
Tamara N FitzgeraldSchool of Medicine, Duke University, Durham, NC, USA. tnfitz@hotmail.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Effective regulatory frameworks, harmonized to international standards, are critical to expanding access to quality medical devices in low- and middle-income countries. This review provides a summary of the state of medical device regulation in the 14 member countries of the College of Surgeons of East, Central, and Southern Africa (COSECSA) and South Africa. Countries were categorized according to level of regulatory establishment, which was found to be positively correlated to gross domestic product (GDP; r

Indexed as

Medical Device LegislationSurgeonsAfrica, SouthernHumansIncomeSouth Africa

Identifiers

PMID33764886
PMCPMC8087432

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.