James Pound, of the MHRA, said: “Medical devices must meet strict standards before they can be used, especially when caring for the most vulnerable patients, including newborn babies.<\/p>\n
“This outcome sends a clear message that the MHRA will not hold back when patient safety is at risk.”<\/p>\n
Sarah Place, of the Crown Prosecution Service, said: “The actions of Harrison and Medicina Limited were completely dishonest and from their fraudulently labelled products, they turned a substantial profit.”<\/p>\n
She confirmed confiscation proceedings under the Proceeds of Crime Act had started “to recover any available funds from this criminal activity”.<\/p>\n
The MHRA said there were no known deaths or serious adverse events reported in the UK associated with the feeding pumps, which had first been placed into the UK and EU markets in 2011.<\/p>\n
Following a safety notice issued by Medicina Ltd and two recalls by the MHRA in 2014 and 2015, 88 pumps were recalled from 34 UK hospitals.<\/p>\n
It is understood the Medicina Ltd feeding pumps were also removed from service in Spain, Australia and New Zealand.<\/p>\n
Gastrostomy “buttons” and blunt fill needles placed on the market in 2012 were brought within scope of the CE certification after intervention from the MHRA in 2014. <\/p>\n
Medicina Ltd said the charges related to historical matters which occurred between 2009 and 2014 and concerned the ownership and management of former company directors during that period.<\/p>\n
While the company said it respected the jury’s verdicts and recognised the convictions, it said they did “not reflect the standards, culture or management of Medicina Limited as it exists today”.<\/p>\n
Medicina Ltd said it had been under an entirely different ownership since 2019, with a new leadership team, governance structure and compliance framework, adding that “product quality, patient safety and regulatory integrity are central to every aspect of the business today”.<\/p>\n
Harrison is due to be sentenced on 23 September at Manchester Crown Court, with the sentencing date for Medicina Ltd yet to be confirmed.<\/p>\n","protected":false},"excerpt":{"rendered":"James Pound, of the MHRA, said: “Medical devices must meet strict standards before they can be used, especially…\n","protected":false},"author":2,"featured_media":678124,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[43],"tags":[102,2960,56,54,55],"class_list":["post-678123","post","type-post","status-publish","format-standard","has-post-thumbnail","category-healthcare","tag-health","tag-healthcare","tag-uk","tag-united-kingdom","tag-unitedkingdom"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/posts\/678123","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/comments?post=678123"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/posts\/678123\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/media\/678124"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/media?parent=678123"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/categories?post=678123"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/tags?post=678123"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}