More than 150 medical devices are recalled from the Irish market annually over safety concerns, according to figures released by the Health Products Regulatory Authority (HPRA).
The latest figures show that the authority issues hundreds of field-safety corrective action notices each year in relation to medical devices.
These notices concern actions aimed at reducing “a risk of death or serious deterioration in the state of health associated with the use of a medical device”. These alerts and can be about a device or a particular lot or batch of the product.
Data journalists working with the International Consortium of Investigative Journalists (ICIJ) had “scraped” 4,789 safety notices and other warnings from the HPRA’s website and uploaded them to a database being built as part of its work on the sector.
While the Irish records have always been publicly available, the consortium of investigative journalists’ website is being designed to enable easier searching and to allow for comparisons with other jurisdictions. The journalists working on the project said the Irish regulator’s website is one of the most difficult to search that it has come across.
The Irish files are among 16,691 records from Hong Kong, the Czech Republic, Italy, Belgium, New Zealand, Denmark and El Salvador that are being added as part of the latest large upload to the ICIJ database.
The International Medical Devices Databasewas first published in November as part of ICIJ's Implant Files investigation. The Irish Times was one of the media organisations involved in the project.
In 2017, there were 519 field safety corrective actions notified to the Health Products Regulatory Authority by manufacturers, of which 178 involved the removal of a product, or batches of the product, from the market. In 2016 the comparable figures were 476 and 147, while in 2015 they were 474 and 160.
Over the same period the authority also issued Dear Health Care Professional letters, which are sent directly to a patient’s doctor when a problem with a medical device involves a small number of people.
The regulatory authority issued 12 such letters in 2015, with 35 and 23 being issued respectively over the subsequent two years.
The authority conducts a risk assessment of all the field-safety correction notices it receives, which it then uses to guide it as to how it should respond. As part of its response, the regulatory authority sometimes issues a safety notice about a particular device. It releases 35 to 45 such notices each year.
Staplers used in surgery
On April 11th, it issued a safety notice in relation to staplers used in surgery which had a defect that could trigger serious post-operative complications including haemorrhage or haemorrhagic shock.
The manufacturers of the product, Ethicon Endo-Surgery LLC, told the authority that 422 of the affected units of the product had been placed on the Irish market, but that there had been no complaints reported to date from Ireland.
The high-priority notice was issued to hospital managers, colorectal surgeons, intensive care staff, procurement managers and others.
Ireland plays an important role in the global medical device sector, with many of the leading multinationals having substantial operations here.
The ICIJ database allows for searchs about a particular product in any of the jurisdictions from which data has been uploaded. It also allows for searches about particular manufacturers.
The EU’s regulatory regime for medical devices is being reformed, with measures to be introduced over the coming years to involve improved oversight and increased transparency. The previous regime was considered by many to be inadequate.
Safety notice
The HPRA issued a safety notice last November about a range of catheters and drainage and feeding tubes to intensive care units, hospitals, nursing homes and hospices.
The product, which is manufactured by an English company called ConvaTec Ltd, was first withdrawn in July because of concerns that it might not be sterile and could lead to patients developing an infection.
“The HPRA are issuing this safety notice at this time, as we have only recently been made aware that the Irish market is affected by this recall and that a significant number of these devices were provided to the market through third-party distributors [AND]various supply routes,” it said.
Notices such as these are being posted on the HPRA website on a regular basis. And its not just mistakes made in manufacturing plants that can create dangers.
Earlier this year hospitals were warned about a counterfeit Chinese medical device being marketed for use on patients with asthma, cystic fibrosis, chronic obstructive pulmonary disese, and other respiratory conditions.
The fake nebuliser masks - devices used to administer medications by way of a mist - copied a product produced by Hangzhou Medtec Devices Co Ltd, of China.
A spokeswoman for the HPRA said the company had informed it that it never sold its product in the Irish market. She also said there was no evidence that the counterfeit product was ever sold here.
One of the most striking aspects of cases where medical devices go wrong is when it involves an implanted device.
In October 2016 the HPRA issued a safety notice about an implantable cardioverter defibrillator made by St Jude Medical, because of problems with the batteries. At the time 349,852 of the implantable devices were “in service worldwide”, the company said.
