Medical devices face tougher premarket testing under new EU laws

BMJ 2017; 357: j1870
Author: Deborah Cohen
“The European Parliament has passed new legislation to tighten regulation of medical devices that will require high risk devices, such as hip implants, to undergo more premarket testing and assessment. European device regulation has come in for criticism after a series of high profile failures—including hip replacements, breast implants, and pelvic meshes—that have resulted in harm to patients.”
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Smart homes, private homes? An empirical study of technology researchers’ perceptions of ethical issues in developing smart-home health technologies

BMC Medical Ethics 2017 18:23
Authors: Giles Birchley, Richard Huxtable, Madeleine Murtagh, Ruud ter Meulen, Peter Flach, Rachael Gooberman-Hill
“Smart-home technologies, comprising environmental sensors, wearables and video are attracting interest in home healthcare delivery. Development of such technology is usually justified on the basis of the technology’s potential to increase the autonomy of people living with long-term conditions. Studies of the ethics of smart-homes raise concerns about privacy, consent, social isolation and equity of access. Few studies have investigated the ethical perspectives of smart-home engineers themselves. By exploring the views of engineering researchers in a large smart-home project, we sought to contribute to dialogue between ethics and the engineering community.”
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Weak Reporting System Let Risky Surgical Device Stay in Use

NYT Health, 8 February 2017
Author: Denise Grady
“Doctors and hospitals failed to tell the Food and Drug Administration about cases in which cancer was spread around inside women’s bodies by a surgical tool used to operate on the uterus, according to a report issued on Wednesday by the Government Accountability Office.”
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Remote monitoring of medical devices in Australia

Med J Aust 2017; 206 (2): 62-63
Authors: Bradley Wilsmore, James Leitch
“The collection, storage and distribution of remote monitoring information by industry are not clearly regulated. Regulation is complex, given all current industry providers have offshore servers and local distribution of data. While some companies have adopted a worldwide information security management system standard (ISO 27001), regulation has been company dependent and the current system is largely self-regulated by industry at the local level. This raises further issues and may exacerbate the potential for a conflict of interest regarding industry involvement.”
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Thousands of pacemakers and defibrillators ‘at risk of hacking’

SMH, 6 February 2017
Author: Julia Medew
“Thousands of Australians with pacemakers and defibrillators in their hearts are at risk of cyber security breaches that could allow somebody to kill them, doctors say. Some cardiologists are also concerned that the multi-billion dollar medical device industry has too much control over devices being implanted in Australians, and that this could lead to over-servicing to boost profits.”
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U.S. judge blocks rule on financial assistance for dialysis patients

Reuters, 12 January 2017
Author: Brendan Pierson
“A U.S. judge on Thursday put on hold a new federal rule that dialysis providers have said would prevent dialysis patients from using charitable assistance to buy private health insurance. U.S. District Judge Amos Mazzant in Sherman, Texas stopped the rule from taking effect Friday as planned. The decision is a victory for dialysis providers Fresenius Medical Care, DaVita Inc and U.S. Renal Care Inc, which filed a lawsuit to block the rule last week.”
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A thousand words in the palm of your hand: management of clinical photography on personal mobile devices

Med J Aust 2016; 205 (11): 499-500.
Authors: Kieran G Allen, Paul Eleftheriou, John Ferguson
“Opportunities to optimise patient care have been enhanced by this immediate transfer of accurate and relevant clinical images. Despite these benefits, photographic documentation of the patient’s condition on PMDs creates a sensitive personal record on inherently insecure devices when the patient is vulnerable. This exposes patients to an ongoing risk of potentially serious consequences and psychological harm in the event of illicit publication. Health care organisations must ensure that security is a paramount concern and that their clinicians obtain consent appropriately to minimise the risk of a breach of patient confidentiality.”
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Introduction to the article collection ‘Translation in healthcare: ethical, legal, and social implications’

BMC Medical Ethics 2016 17:74
Authors: Michael Morrison, Donna Dickenson, Sandra Soo-Jin Lee
“New technologies are transforming and reconfiguring the boundaries between patients, research participants and consumers, between research and clinical practice, and between public and private domains. From personalised medicine to big data and social media, these platforms facilitate new kinds of interactions, challenge longstanding understandings of privacy and consent, and raise fundamental questions about how the translational patient pathway should be organised.”
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Bill to boost medical research funding and speed drug approval passes US house

BMJ 2016; 355: i6498
Author: Michael McCarthy
“After two years of negotiations, the controversial 21st Century Cures Act was passed by the US House of Representatives on Wednesday 30 November by a vote of 392 to 26. The bill boosts funding for medical research and mental health and substance abuse care—but also contains provisions to speed up drug and medical device approval that consumer groups say will lower safety standards and put patients at risk.”
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FDA Faults Hospitals For Failing To Report Safety Problems With Medical Devices

NPR, 28 October 2016
Author: Chad Terhune
“Federal regulators said 12 U.S. hospitals, including well-known medical centers in Los Angeles, Boston and New York, failed to promptly report patient deaths or injuries linked to medical devices. The Food and Drug Administration publicly disclosed the violations in inspection reports this week amid growing scrutiny of its ability to identify device-related dangers and protect patients from harm.”
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