Tighter Regulation of Medical Devices Needed

Tighter Regulation of Medical Devices Needed

The Poly Implant Prothèse (PIP) implant scandal raises questions about the EU's regulation of medical implants and devices. Writing on her blog this morning, following the reported arrest of the founder of PIP, Ms Prendergast said the Medical Devices Directive must be revised to strengthen traceability of all implants.

"This scandal emerged when it was discovered that cheaper, industrial-grade silicone was used in the manufacturing of breast implants by a French company. These implants were then exported to other countries. This has thrown up a number of issues relating to the regulation of medical devices and the tracing of such devices post-implantation.

"Ireland had previously recalled the implants in March 2010 and has also advised all implanting hospitals to contact anyone who may have received them.

"As a health practitioner, I am very concerned about a number of elements in this scandal:

- the lack of regulation: the regulatory framework in operation was simply not rigorous enough.

- the lack of record keeping: this has led to uncertainty and delays in identifying women with PIP implants.

- the lack of adequate information: while spokesperson for the Irish Association of Plastic Surgeons Professor Earley has said, there is "no definite cancer link" between implants and in particular the PIP implant, very little is known about the impact that not-safe-for-human-consumption silicone will have on the body.

"Just this week, the European Commission confirmed in the Parliament that it will present a proposal to revise the Medical Devices Directive which governs this area.

"I welcome this announcement and believe a number of critical issues need to be addressed in light of this scandal.

- Better regulation of producers of medical devices: this should include spot inspections of manufacturers. Currently, manufacturers are given a six-week notice period - this is not acceptable.

- Unscrupulous manufacturers could use this period to disguise shoddy practices and temporarily bring unsafe practices into line. Unannounced visits should be the only option.

- Traceability - this scandal has highlighted the shortcomings regarding record keeping. Hospitals and medical facilities should be required to maintain records of the make, model and manufacturer of each medical device received by patients. All medical devices should be bar-coded or given a serial number so they can be easily traced.

"This scandal follows the withdrawal last year of DePuy ASR hip replacements and Irish surgeons are concerned about the use of metal-on-metal implants generally. This calls into question the regulation of the entire medical devices sector which generates jobs and tax revenues in Ireland and elsewhere. The undermining of public confidence in this industry is unfair to responsible manufacturers and is causing worry among those with other types of implants and devices.

"Swift action must be taken to ensure a far more rigorous verification regime is in put in place for any device sold in the EU."