Risk Management in IEC 60601-1 Third Edition

Risk Management in IEC 60601-1 Third Edition

Risk Management is a critical factor in IEC 60601-1 Third Edition. This is one of the important additions that have been made to this edition from the previous one. The new legislation requires that Risk Management be implemented in the product lifecycle throughout the standard.

Risk Management at the core of the standard

ISO 14971, which deals with application of Risk Management to medical devices, is deeply embedded into IEC 60601-1 Third Edition. Full application of ISO 14971 is mandated for all medical equipment complying with IEC 60601-1. Also, as many as 85 additional references are made to Risk Management throughout this document. These are a culmination of discussions the IEC’s Subcommittee initiated as far back as 1996.  The scope of this committee was to revise the IEC 60601-1 Standard’s general requirements for safety.

Safety as an “Essential Performance”

The outstanding feature of this standard is that it takes a new look at safety. It makes safety an “Essential Performance”, a change from its predecessor’s scope that required only “Basic Safety”. By “Essential Performance” is meant that aspect of the electromedical device’s performance that can affect safety directly, and requires this aspect to be evaluated according to ISO 14971.

Risk Management at all stages

Risk Management requirements ofIEC 60601-1 Third Edition fall under these four categories:

–        Apart from general requirements set out in 14971; Risk Management must be used to determine whether additional hazards beyond those addressed in IEC 60601-1 Third Edition exist

–        Risk Management is used to determine equivalent safety for alternative compliance

–        Risk Management is used to determine compliance criteria

–        Risk Management is also used to determine or refine test methods.

Thus, Risk Management is incorporated into this standard, while it was vague and subjective in the 2^nd edition of this standard.

 

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Medical compliance

Medical compliance

Medical compliance, rather lack of it, is perhaps the most detested word for the medical fraternity. Medical compliance is, in simple terms, adherence to prescribed treatment. Many patients fail their doctors by not following treatment courses properly. The reason most people do this is that they feel better after a few doses, and take a self-decision that they are fine and don’t need to complete the course. This makes the treatment ineffective, because most medicines are administered as courses.

There is another, rather sad reasons for which a few patients cannot ensure medical compliance. This is when they are unable to afford the medicines. Although common in the developing world, there are cases of non-adherence to medical compliance due to lack of affordability in the US, too.

Why is medical compliance important and necessary?

Most modern medication, ranging from old and new generation antibiotics to oncology drugs, are have a mode of action that aims at continuously targeting symptoms. They work by repeatedly targeting the symptom-causing organisms or body condition. For this reason, it is necessary to take continued dosage, which is what is normally prescribed. Medical compliance means taking the full prescribed dosage in the format and quantity the doctor advises. This full dosage ensures the desired effect of the drug or any other medication.

Medical compliance vs. regulatory compliance

Some people can confuse medical compliance with regulatory compliance. The FDA is the US’ regulatory body. It regulates everything from drugs and other medicines to medical devices to food to the payment card industry. Here, compliance means meeting the regulatory requirements set out by the FDA. The same applies to regulatory bodies across the world. There is little in common between medical compliance and regulatory compliance, apart of course, from the fact that both involve a degree of compliance, albeit to entirely different things.

 

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IEC 60601-1 Third Edition –introduction and implementation dates

The IEC, which stands for International Electrotechnical Commission, dates its founding to more than a century back, to 1906. It is the world’s leading voluntary organization for regulation of the technologies that collectively go into electronic components and are bunched together as electrotechnology.

In setting standards for electronic and electrical gadgets, the IEC regulates, in effect, millions of electronic devices that go into the market. It has set out the IEC International Standards and Conformity Assessment Systems, ensuring compliance with which these devices work safely and effectively.

Medical Safety IEC 60601-1, 3rd Edition

The IEC 60601-1, 3rd Editionconcerns regulations for electronics that go into medical devices. These are the highlights of IEC 60601-1 standard, 3^rd Edition:

More than 60 device standards are derived from this standard, thus making it the parent standard for these device standards. The third edition was issued in 2005, and has set the following mandatory adaption dates for compliance for these respective markets:

• Europe: June 1, 2012
• Canada: June 1, 2012
• USA: July 1, 2013

Highlights

Medical device manufacturers in all these markets must conform to new revised guidelines within the deadlines prescribed for their respective markets. Apart from using risk management throughout, the other highlight of the newly revised IEC 60601-1, 3rd Editionstandard is that it is less prescriptive in many areas. It leaves many such areas for broader interpretation. Also, the new IEC 60601-1, 3rd Edition requires that all applicable collateral and particular standards must be used for compliance.

 References:

http://www.eisnersafety.com/safety_articles/product_safety/work_in_progress_iec_60601-1_medical/#.UDcQU6N21iA

http://www.gmcompliance.com/iec-60601-1/

 

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Getting IEC 60601-1 3rd Edition Certification

Getting IEC 60601-1 3^rd Edition Certification

Major clause

The IEC 60601-1 Third Edition has a major clause. This is an addition to the existing regulation. Accordingly, an electronic medical device has to conform to the ISO14971 regulations, which relate to risk management. According to this regulation, a medical device manufacturer has to implement risk management during the product life cycle to ensure the product’s safety.

In order to ensure that medical devices are safe and effective for use and performs to prescribed standards in bringing about the desired therapeutic effect; the IEC 60601-1, 3rd Edition has also updated many other regulations in relation to the following:

• general requirements for medical devices;
• standards for identification, marking and providing accompanying documents; hazards (electrical, mechanical, radiation, temperature and fire, accuracy, etc.)
• hazardous situations and fault conditions.

Getting IEC 60601-1 Certification

Since Risk Management through the product lifecycle is mandatory; a medical device company has to have a Risk Management File (RMF) in order to obtain IEC 60601-1 3rd Edition certification. This is how the process goes:

–        Step 1:  To gain education on how to ensure compliance with the 3rd Edition

–        Step 2: ISO 14971 audit, which should increase the Risk Management pass rate up to 80 percent

–        Step 3: Preliminary Design Package, which includes preliminary reviews of the product and the Risk Management File, a critical document

–        Step 4: Testing, the final stage to certification of IEC 60601-1 3rd Edition

References:

http://www.eisnersafety.com/safety_articles/product_safety/work_in_progress_iec_60601-1_medical/#.UDcQU6N21iA

http://www.gmcompliance.com/iec-60601-1/

 

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History of FDA GMP requirements

History of FDA GMP requirements

The FDA has Good Manufacturing Practices (GMP) requirements for a range of items. One of them is Active Pharmaceutical Ingredients (API). FDA GMP requirements are established under the FDA Act. In Sec. 501 (a) (2) (B) of the Act (21U.S.C. 351(a) (2) (B)); the FDA seeks to establish API as a drug. It makes a drug subject to GMP. This is a culmination of a series of regulations on drugs and food that dates all the way to 1906, the year in which the Food and Drugs Act of 1906 was promulgated. A major landmark was the Food, Drug and Cosmetic Act of 1938.

Nuances

Since they are important regulations, the finer aspects of GMP requirements need to be understood. Sec. 501 (a) (2) (B) of the FD & C Act requires that drugs be manufactured, processed, packed and held according to current good manufacturing practice (cGMP). GMP for API thus has a starting point in this legislation.

One of the important points relating to GMP is that FDA makes no distinction between API and finished pharmaceuticals, and failure of either to comply with cGMP constitutes a failure to comply with the requirements of the Act.

Historic guidances

Important regulations were passed in 1978 and 1998, and other guidances were established in PHRMA BPC Guidance, WHO Guidance and CEFIC Guidance. All of these were effectively replaced by the ICH Q7A of November 2000. It was accepted as an official guidance by the FDA the following year. Q9 Quality Risk Management was issued in 2006; Q10 Pharmaceutical Quality System was issued in April 2009, and the Q8 (R2) pharmaceutical development in November 2009. All these are essentially guidances on what a pharma company needs to do with regard to API.

 

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FDA API GMP requirements –current quality guidelines

FDA API GMP requirements –current quality guidelines

The US FDA has set out Good Manufacturing Practices (GMP) requirements for a number of products. The Food, Drug and Cosmetic Act, a US law,empowers the FDA with authority to regulate a number of industries.

Accordingly, the FDA GMP requirements and guidelines exist for a clutch of products and fields. GMP’s for some of these, concerning related areas like drug products, API, excipients, devices and nutritional supplements, may appear to be linked and similar, but they are not. Their definitions, identity, application and requirements may have many common qualities, but each has unique FDA GMP requirements.

Current quality guidelines for API

There are a number of current quality guidelines for FDA GMP requirements. A few of these are:

ICH Q 7

ICH Q 7 was issued as ICH Q 7A in November 2000. It was officially accepted by the FDA as a guideline for API in August 2001.

Q 8 (R2)

Concerning pharmaceutical development, Q 8 (R2) is another of the current FDA GMP requirements. It was issued in November ’09. It has applications to GMP’s.

Q 9

The Q9, concerning Quality Risk Management, was issued in June ’06.

Q 10

The Q 10, specific to the Pharmaceutical Quality System, was issued in April ’09.

Other guidelines concerning PV for APIs

The FDA also has draft guidances for process validation. These are:

• General Principles and Practices (November 2008)
• Pharmaceutical Components at Risk for Melamine Contaminations(August 2009)
• Guidance for Industry –cGMP for Phase I Investigational Drugs (June ’08)
• CPG Sec. 490.100 Process Validation Requirements for Drug Products and Active Pharmaceutical Ingredients Subject to Pre-Market Approval
• 7356.002F –Active Pharmaceutical Ingredients are other important documents.

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Essential Performance requirements under IEC 60601-1 Third Edition

Risk Management has been considered a critical factor in the revised IEC 60601-1 Third Edition. Not only does the new standard require that Risk Management be implemented in the product lifecycle throughout; it also requires complete adherence to ISO 14971, the ISO standard on risk management in medical devices.

“Essential Performance vs. Basic Performance”

Another crucial component of IEC 60601-1 Third Edition is that it makes safety an “Essential Performance”. This is change from the earlier version, in which required only “Basic Safety”. Essential Performance is that aspect of the medical device’s performance that has a direct bearing on the device’s safety. It requires evaluation in accordance with ISO 14971. According to this amendment, Essential Performance is performance, other than that related to Basic Safety, whose loss or degradation beyond the limits specified by the manufacturer results in unacceptable risk.

Clause 4.3

Clause 4.3 of IEC 60601-1 Third Edition is the normative guide to Essential Performance requirements under IEC 60601-1 Third Edition. It states that “The manufacturer shall identify which functions of the ME equipment and ME systems (the 2012 amendment adds Medical Software Systems to this list) are essential performance.” So, where this   standard specifies that Essential Performance is to be maintained following a specific test; the functions determined above (using Risk Management) shall be used and compliance shall be checked by inspection, and if necessary, by functional test.

Highlights

• The manufacturer has to define Essential Performance in accordance with manufacturer’s policy for Risk acceptability
• Essential Performance cannot be identified where there is no part-two standard
• Both the General Standard and the new EMC standard define Essential Performance as part of the Risk Analysis Process
• Essential Performance must thus be identified each time a Risk Analysis is performed
• Diagnostic functions essentially qualify as Essential Performance
• Monitoring does not fall under Essential Performance, but alarms need to be given
• Loss of function for surgical devices is usually Essential Performance because they need to be re-anaesthetized
• Loss of most alarm functions is usually Essential Performance.

 

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Compliance Webinars

Looking for compliance webinars?

Compliance webinars educate participants about compliance. This education is needed because many companies work on products that need compliance as set out by regulatory bodies such as the FDA. When looking for compliance webinars, try to keep these points in mind:

Why are they needed?

Most compliance webinars are for experienced professionals. They are generally offered by continuing education providers (CPE), who have a panel of experts on their rolls. Compliance webinars are offered online, and are needed because professionals need to keep updating their knowledge of their field.

What to look for?

The most important things to look for when trying to enroll for compliance webinars are these:

Relevance of topic: This should be the most important aspect to consider when deciding to participate in a compliance webinar, because compliance is a very intricate and complex area. It is virtually a sea in terms of size of information. Make sure that the compliance webinar has a topic that is specific to what you are looking for.

Panel of experts: The experts should be well-versed in their field. When you find an expert, make a search on the Net about him or her. Then take a call on whether you are convinced about the expert’s ability to satisfy your specific need.

Other aspects: Although they seem trivial in relation to the above two; a couple of other factors could be taken into account while deciding on your choice of a compliance webinar. You could look for the ease of payment options on the site. You could also consider the service aspect, such as the way the staff of the company that offers compliance webinars conduct themselves over the phone, the ease or willingness with which they sort matters out and so on.

 

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API Process Inspection –what does the FDA expect?

 

 

API Process Inspection –what does the FDA expect?

Ironical as it may sound; there is no API-specific GMP guideline from the FDA! It has only some broad, yet clearly laid out rules and expectations, which have to be adhered to.

The FDA and API Process Inspection

Rules regarding what the FDA expects are mentioned clearly in the document that lays down the principles of an FDA API process inspection, namely FDA Program Guidance Manual (Program 7356.002F). So, the FDA sticks to what is prescribed in this document:

–        GMP is a must for the FDA

–        It recognizes Q 7 as the primary API GMP. If you cannot follow Q 7, you can expect an equivalent activity, but are expected to demonstrate that the alternative activity you used did not in any way violate the basic requirements set out in this document.

–        This program manual is applicable for API manufactured by synthesis/fermentation and not for dosage forms

–        This document applies to domestic and foreign inspections

–        Uses a six-system approach

Other requirements

–        Expects compliance with FDA regulations

–        Compliance with Q 7 or equivalent

–        Procedures and documents must be clearly written down

–        Should have appropriate Quality System in conformance with Q 7, to ensure that an international or domestic guidance is adhered to

–        Should have sound Quality Practices

–        A sound and documented QMS that is “shown to work”

–        Appropriate Change Control Systems

–        Cleaning systems and records

–        Appropriate Validation and Qualification performed and documented

–        Written contracts and Quality Agreements where appropriate

–        Auditing programs and documentation

Systems that will be examined

During an FDA API process inspection, it inspects the following types of systems:

–        Quality System

–        Facilities and Equipment

–        Materials System

–        Production

–        Packing and labeling

–        Laboratory Control System

 

Reference:

http://www.fda.gov/downloads/ICECI/ComplianceManuals/ComplianceProgramManual/UCM125420.pdf

 

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API Process Inspection –what does the FDA expect?

 

 

API Process Inspection –what does the FDA expect?

Ironical as it may sound; there is no API-specific GMP guideline from the FDA! It has only some broad, yet clearly laid out rules and expectations, which have to be adhered to.

The FDA and API Process Inspection

Rules regarding what the FDA expects are mentioned clearly in the document that lays down the principles of an FDA API process inspection, namely FDA Program Guidance Manual (Program 7356.002F). So, the FDA sticks to what is prescribed in this document:

–        GMP is a must for the FDA

–        It recognizes Q 7 as the primary API GMP. If you cannot follow Q 7, you can expect an equivalent activity, but are expected to demonstrate that the alternative activity you used did not in any way violate the basic requirements set out in this document.

–        This program manual is applicable for API manufactured by synthesis/fermentation and not for dosage forms

–        This document applies to domestic and foreign inspections

–        Uses a six-system approach

Other requirements

–        Expects compliance with FDA regulations

–        Compliance with Q 7 or equivalent

–        Procedures and documents must be clearly written down

–        Should have appropriate Quality System in conformance with Q 7, to ensure that an international or domestic guidance is adhered to

–        Should have sound Quality Practices

–        A sound and documented QMS that is “shown to work”

–        Appropriate Change Control Systems

–        Cleaning systems and records

–        Appropriate Validation and Qualification performed and documented

–        Written contracts and Quality Agreements where appropriate

–        Auditing programs and documentation

Systems that will be examined

During an FDA API process inspection, it inspects the following types of systems:

–        Quality System

–        Facilities and Equipment

–        Materials System

–        Production

–        Packing and labeling

–        Laboratory Control System

 

Reference:

http://www.fda.gov/downloads/ICECI/ComplianceManuals/ComplianceProgramManual/UCM125420.pdf

 

Contact Detail

webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

Phone: 800-447-9407
Fax: 302-288-6884

1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801