Eisner Safety Consultants

On June 1, 2011 Health Canada issued a notice releasing the final guidance on ‘Information to Be Provided by Manufacturers for the Reprocessing and Sterilization of Reusable Medical Devices.’

The following text has been taken straight from the Health Canada website on the page for this final guidance document

“A draft version of this guidance document was first published and released for consultation in 2006. Comments from stakeholders and the Scientific Advisory Panel on Reprocessing of Medical Devices have been considered in producing this final version.

To reduce the risks associated with the use of reprocessed reusable medical devices, Health Canada has developed this guidance document to aid manufacturers of Class I, II, III and IV reusable medical devices in the preparation of reprocessing and sterilization information to be provided with these devices.

The guidance document is intended to assist manufacturers in understanding and complying with the regulatory requirements of section 21(1)(i) of the Medical Devices Regulations as they pertain to the directions for use for reusable medical devices. This guidance document should be used in conjunction with the Guidance Document on Recognition and Use of Standards under the Medical Devices Regulations.

In order to provide industry with sufficient time to meet the specifications of the guidance document, Health Canada will allow a six-month transition period commencing on the date of implementation, June 1, 2011. Following the transition period, Health Canada will expect manufacturers to meet the specifications listed in the guidance document.

Further information on this guidance document, and a summary of comments received and Health Canada’s responses to them, may be obtained by contacting:

Device Evaluation Division
Medical Devices Bureau
Therapeutic Products Directorate
Health Canada
Phone: 613-954-0297
Fax: 613-957-9969
E-mail: DED_manager@hc-sc.gc.ca

Published by authority of the Minister of Health

Date Adopted 2011/06/01

Effective Date 2011/06/01

Foreword

Guidance documents are meant to provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. Guidance documents also provide assistance to staff on how Health Canada mandates and objectives should be implemented in a manner that is fair, consistent and effective.

Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach. Alternate approaches to the principles and practices described in this document may be acceptable provided they are supported by adequate justification. Alternate approaches should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.

As a corollary to the above, it is equally important to note that Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, in order to allow the Department to adequately assess the safety, efficacy or quality of a therapeutic product. Health Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented.

This document should be read in conjunction with the accompanying notice and the relevant sections of other applicable guidance documents.”

From AAMI News: July  2011:

E-Submissions Coming for Medical Device & Pharmaceutical Manufacturers http://ht.ly/5y1ZQ

The Oregon Bioscience Association is offering a 2 day course on Internal Auditing to ISO 9001 & ISO 13485.  This is perfect for any Medical Device Company that needs to set-up an internal audit program to meet the requirements of ISO 13485 or other regulatory requirements.  Many small bioscience companies don’t have the internal expertise so they tend to farm out the work but if they can afford to train one or more of their internal resources this will benefit them over the long haul as these people are also good resources when it comes to CAPA ‘s and understanding the Quality System requirements that are mandated on many medical device manufacturer’s.

24 June 2011 – From Eucomed e-newsletter – European Commission publishes draft regulation on electronic instructions for use (IFU) of medical devices.

‘Stakeholders can send their comments by 8 August 2011.

The Eucomed Alternative Labeling Task Force will meet on 1 July 2011 to analyse this latest version of the proposal, which was previously extensively discussed with the European Commission during its initial development.

For more information on the Eucomed Alternative Labeling Task Force or if you have any questions, please contact Dario Pirovano (Dario.pirovano@eucomed.org).‘

Draft regulation on Electronic IFU for medical devices.

Do you have EU transition period questions related to the MDD & AIMDD Harmonized Standard EN IEC 60601-1:2006 (or sometimes known as 3rd edition of EN IEC 60601-1), its’ collaterals (EN IEC60601-1-XX) and its’ particulars (EN IEC 60601-2-XX) standards?  If you do, you have until June 30th, 2011 to submit your questions to an expert team, at 60601Ed3.NBMED.issues@gmail.com, that will endeavor to answer these questions by September 30, 2011 for this 1st round of this new group.  Please read the below letter that have been sent to many different places around the world but note the only questions that will be answered are not the technical issues of how to apply 3rd ed. of EN IEC 60601-1 or even any transitional questions in regard to the FDA (ANSI/AAMI/ES 60601-1), Health Canada (CAN/CSA C22.2 No. 60601:08), MHLW (Japan), or SFDA (China) but only with respect to the implementation of EN IEC 60601-1, 3rd edition in regard to CE Marking under the MDD and AIMDD.  Several years ago there was a FAQ document issued that was on the older version of the CENELEC website when the site changed that link disappeared.  Only just before this letter (below) was issued about the submission of additional transitional questions with regard to 3rd edition of EN IEC 60601-1 did this FAQ document show up again on the CENELEC website in the Medical Equipment Technology Sector.  This FAQ document is an excellent primer for understanding some of the transitional issues for 3rd ed of EN IEC 60601-1 with respect to the MDD & AIMDD.  With this group hopefully collecting additional transition issues the FAQ document will grow and improve our overall understanding of some of the challenges with the transition of EN IEC 60601-1 3rd edition and its’ 60 or so related standards.

I would like to also thank Martin Schneeberg & Peter Linders for allowing me to share this with all my clients and website visitors.

Implementation of EN IEC 60601-1 3rd edition

Request for Issues

on the use of the standard for CE-conformity purposes

When the transition period was defined for EN IEC 60601-1:2006 (replacing the 1988 version with its two amendments), several questions arose. These questions were included in a FAQ document that was posted at the CENELEC web site (click here) to give all users the same interpretation[1]: (click here).

The transition period, after which only the 2006 edition will be giving presumption of conformity with the relevant Essential Requirements of the Medical Device Directive (93/42/EC), is now well underway. As an increasing number of manufacturers are implementing this version of the standard, more questions come up. In particular this is the case in conversations between manufacturers and involved authorities or Notified Bodies considering CE-conformity purposes.

In an attempt to support these discussions, and to harmonize responses, we are looking for specific matters that have arisen and that may have wider relevance. Together with regulatory experts, we will seek answers to those matters that reflect a consensus opinion of the Medical Notified Bodies. Clearly, this is not a request for technical matters, e.g., for required test conditions, but rather unclear situation. A few examples of such matters are given in the annex.

If you know of such matters, or even have experienced some yourselves, please share these. If you have reached agreement on these matters or you have proposals for the same, and wish to share: these are also very welcome. As indicated, the matters will be compiled and given to experts for sound advice, followed by scrutiny from NB-MED experts, resulting in the best available recommendations for the matters indicated. This advice will be made publicly available.

Please submit your contributions to: 60601Ed3.NBMED.issues@gmail.com. Note that not all contributions may receive individual responses. We will start work with material submitted by 30 June 2011, yet contributions after that date remain welcome. We expect first results by 30 September.

Thank you for your consideration and valuable contributions.

Martin Schneeberg (TÜV SÜD PRODUCT SERVICE, member of UK 811.1, IEC TC62A, WG14, MT28, A1PMT, IECEE RM TF)

Wolfgang Leetz (Siemens AG, Healthcare Sector, chair of DKE Division 8 (electro medical equipment, electro acoustic, ultrasound, laser), chair of COCIR Standardization Policy Focus Group)

Peter Linders (Philips Healthcare, chair of CENELEC TC 62, chair of COCIR Technical and Regulatory Affairs Committee, member of IEC/TC 62 CAG, A1PMT)

Annex – Examples of questions sought

Q1. Valid EC Design-Examination certificate period vs. DOCOPOCOSS: 2012-06-01:
Example: Suppose an MDD class IIB or III electrical medical equipment was placed on the EEA in 2009. It has a signed EC Design-Examination Certificate by a NB based on 2Ed EN 60601-1, valid until 2014-01-01 (five years).

Question: Is this product affected by the DOCOPOCOSS related to EN 60601-1:1990 (+ am1 + am2), June 1st 2012? Keep in mind that a valid EC certificate has been issued by a NB which is valid 5 years up to 2014.

Q2. Future totally new particular standards:
For a specific MEE does not exist a specific particular standard related to 2Ed EN 60601-1. However, for this specific MEE a totally new particular standard related to the 3Ed EN 60601-1:2006 is work in progress. This question is relevant at least for:
– 60601-2-63: for dental extra-oral x-ray equipment,
– 60601-2-64: light ion accelerators,
– 60601-2-65: for dental intra-oral x-ray equipment,
– 60601-2-66: hearing aids and hearing systems

Officially such MEE’s shall fulfil the complete 3Ed EN 60601-1:2006 plus the relevant particular standard 60601-2-XY at the date 2012-06-01, unless there is a specific transition period for the applicable particular standard. Usually no specific transition period for the totally new particular standards are defined in the OJ, therefore, 2012-06-01 will apply.

Is there any guidance beyond the general advice to discuss specific problems related to the application of these new standards with the NB and using Risk Management?

Can 3 years transition period for the EN 60601-2-XY be claimed starting from publishing the EN version of the particular standard?

Q3. Is ZLG paper 3.5 A1 legally binding for EU NB’s and MEE manufacturers:
The ZLG-paper 3.5 A1 addresses a valid concern extremely clear: “The missing new assessment by the manufacturer after the end of the “doc” or the missing knowledge about the existing of new harmonized standards or scientific knowhow are substantial NON-conformities. If these NON-conformities will not be adequate corrected, the certificates have to be suspended or withdrawn.”
Is this paper legally binding? Am I allowed to ignore it? In clear words: If the “doc” is over and I have not objective evidence about the new 3Ed EN 60601-1:2006 requirements in a point-by-point protocol format, is my NB forced to suspend or withdraw my CE-certificate?

[1] Collateral standards under the MDD & AIMD: CLC/TC 62 questions and answers on the EN 60601-series of standards in relation to the MDD and AIMD