Web-based translators are breaking barriers among geographically based tongues. A bigger problem is conveying the intended meaning behind the words even among people who speak the same “tongue.” They may be not speaking the same “language.” One example is the spacecraft failure a few years ago when one part of the team used English units and another used metric units. Another area where the ability to convey the proper meaning of words is essential is in medical device manufacture. Incorrect communication can compromise patient and public safety.
Informative, clearly-written standards and guidance documents for the manufacture of complex, high value products, helps bridge the language gap. Cleanliness issues for single use and reusable medical devices exemplify the complexities and challenges of crafting useful standards.1 A number of groups including ASTM, AAMI, and ISO are developing standards and guidance documents.
WORKSHOPS
A recurring message at a recent FDA workshop2 was the need for more effective communication. Speakers noted that Instructions for Use (IFU) must be explicit; they must be understood; and they must be followed. In one study, none of 12 facilities complied with all cleaning instructions. No significant residue was found on external surfaces, but 95% had residue on internal surfaces. The need for clear, understandable IFUs, as well as the necessity of following the instructions, was also recognized at a risk management session at MD&M West 2012.3 Given the inherent “chronic emergency” status of many health care facilities, cleaning of reusable devices by the facility may take a backseat to immediate patient needs. In one notable instance, a major manufacturer of a reusable device takes the used instruments back from the healthcare facility to reprocess, rather than have the facility clean them.4
FDA GUIDANCE
There is an increasing awareness that sterilization alone is not enough; the device must be clean as well as sterile. The FDA workshop included a discussion of a draft FDA guidance document5 currently under review. It specifically calls for cleaning prior to sterilization or disinfection processes. It is clearly stated that validation of reprocessing methods are to be based on conditions of use. There is also wording to the effect that where lubricants are used in such devices, lubricants are one of the variables that must be controlled. Controlled Environments readers may recall6 that due to environmental concerns, some lubricants may no longer be available or may be reformulated. Device manufacturers need to be aware that lubricants used by themselves or suppliers may have changed or will change and should demonstrate that these changes pose no additional risk to their product.
The guidance document provides a detailed section addressing the validation of cleaning processes including cleaning and sterilization. The FDA recommends that spore log reductions studies no longer be used to validate the effectiveness of cleaning medical devices. The FDA recommends quantitative test methods.. There is currently no correlation between soil removal and spore reduction; this may present a challenge in providing historical comparison for existing devices.
The FDA has recognized consensus standards and guidance regarding device sterilization and disinfection. While many standards address steam, ethylene oxide, and high-level disinfection, there is limited guidance for medical device cleaning. Two AAMI documents 7,8 provide examples of medical device processes, material, test methods and acceptance criteria for cleaning medical devices. Additionally TIR 30:2011 provides detailed descriptions for the use of soils representative of the worst case clinical environments, e.g. skin, blood, mucous tissue, the devices will be exposed to in clinical use.
ELECTRONICS
One issue in validating cleanliness of medical devices is that the standards, guidance, and requirements for cleaning are often related to the specific manufacturing sectors involved in developing the document. For example, electronics assemblers are most often concerned with ionic contamination and issues that are associated with aerospace, military, and consumer applications. The IPC has recently published an impressive updated and consolidated version of their cleaning handbook9 that will be of benefit to electronics assemblers. At the same time, the document is being further expanded. As part of our involvement in this effort,10 we have suggested that there be additional cross-cultural communication and coordination with the medical device community.
References
- B. Kanegsberg and E. Kanegsberg, “Contamination Control In and Out of the Cleanroom: ASTM Update,” Controlled Environments Magazine, Feb., 2012.
- FDA Public Workshop – Reprocessing of Reusable Medical Devices, June 8-9, 2011,
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm252205.htm#agenda . - A. Snow and M. Barille, “Risk Management for Medical Devices: Applying 14971 Effectively Using Risk Assessment and Reliability Tools,” MD&M West 2012 (Anaheim, CA), Session 202, Feb. 14, 2012.
- J. Broad, personal communication.
- “Draft Guidance for Industry and FDA Staff – Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling”;
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm252999.htm . - B. Kanegsberg and E. Kanegsberg, “Contamination Control In and Out of the Cleanroom: Finding the Optimal Analytical Test: Parts 1 and 2,” Controlled Environments Magazine, Nov. and Dec., 2010.
- AAMI TIR 30:2011, A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices.
- AAMI TIR 12:2010, Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers.
- IPC-CH-65B “Guidelines for Cleaning of Printed Boards and Assemblies,” for Table of Contents, go to
http://www.ipc.org/TOC/IPC-CH-65A.pdf - IPC 5-31 Cleaning and Alternatives committee meeting, IPC APEX Conference and Exposition, San Diego, CA (2012).
Barbara Kanegsberg and Ed Kanegsberg, Ph.D. “The Cleaning Lady” and “The Rocket Scientist,” are independent consultants in surface quality including critical/precision cleaning, contamination control, and validation. They are editors of the expanded, updated two-volume second edition of “The Handbook for Critical Cleaning,” CRC Press. Contact BFK Solutions LLC, 310-459-3614; [email protected]
John J. Broad is a senior consultant at NAMSA, Irvine, CA and a specialist microbiologist with ASM. He is active in AAMI/ISO sterilization subcommittees. His publications include articles for Controlled Environments and a chapter in “The Handbook for Critical Cleaning, Second Ed.” Contact John at 949-452-8015, [email protected]
