By Robert J. Kerwin
With the gradual reopening nationwide of the economy, we are understandably focused on getting back to business, while ensuring the health and safety of our families. Raising a discussion of new ‘refurbishing standards’ for certain non-imaging medical equipment may provoke the question: how could this be relevant to my business?
Standards are essential tools for technology and business. One day the draft standard may become the industry standard or… a regulatory requirement. Standards offer important opportunities for consensus. Standards may provide key rules and metrics for technology and trade. The American National Standards Institute requires in its ‘Essential Requirements’
that the standards development process not be dominated by any single interest, category, or organization. It requires a balancing of interests and good faith efforts to harmonize. There should be no undue barriers to participation.
The International Electrotechnical Commission (IEC) is another highly respected standards organization. Many consider the IEC to be the leading organization that prepares international standards for electrical, electronic, and related technologies. The IEC provides a platform for discussion and development of international standards. During its prestigious history, the IEC technical committees have considered devices ranging from instruments used in connection with ionizing radiation to MP3 players.
One draft IEC standard, IEC 63120, which was prepared by an IEC Working Group and circulated for comment is titled 'Refurbishment of medical electrical equipment, medical electrical systems and sub-assemblies and reuse of components as part of the extended life-cycle'. The standard does not cover medical imaging equipment which is addressed by a separate IEC standard. Many aspects of the IEC 63120 refurbishment process are very carefully considered and specify necessary risk management steps. The sections covered range from safety to the establishment of a refurbishment plan. Under the standard, refurbishment must be conducted under a certified quality management system such as ISO 13485:2016 or the equivalent. The refurbishment process of sub-assemblies is also addressed.
The IEC draft reviewed includes language that may change, if ultimately adopted, who may refurbish and the requirements when the refurbishment is not performed by the manufacturer. Section 4.1 of the General Requirements for Refurbishment provides the refurbisher:
• should be qualified by the Manufacturer prior to authorization;
• should be authorized by the Manufacturer;
• should be controlled by the manufacturer in an appropriate way;
• should be accountable to provide feedback to the manufacturer; and
• there should be a quality assurance agreement regarding post market information between the refurbisher and the manufacturer.
While other requirements in the standard appropriately address important knowledge areas such as sterilization, disinfection and testing, the standard does not identify why those who refurbish must be qualified, approved and accountable to a manufacturer. Parenthetically, I am not aware of manufacturers who would voluntarily approve refurbishers who are not otherwise involved in a manufacturer joint venture or parent/subsidiary business arrangement. Such standard requirements seem inconsistent with appropriate balancing of interests and other requirements for adoption of a national or international standard. We hope that the highly respected IEC would not issue final approval on a standard which apparently requires manufacturers to vet, approve and control the refurbishing process. Perhaps there is another draft in the offing which omits this requirement. Compliance with QMS and safety requirements does not always necessitate that only those approved by the manufacturer may refurbish.
About the author: Robert J. Kerwin is the general counsel for IAMERS, the International Association of Medical Equipment Remarketers and Servicers.