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    Regulations and Standards Ireland

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    Regulations and Standards Ireland

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    Regulations and Standards Ireland

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    Unit Five Regulations and Standards ‘Leaming objectives | 2 REFERENCE; u FDA(US) HPRA(RELAND) ‘Department of Health and Children ip:wow dob Wealth Products Regulatory Authority (HPRA) since July 2014 ttps//www peas formaily Irish Medicines Board (IMB) ‘The mission ofthe Heth Products Regulatory Authority (HPRA) is ‘to protect and enhance public and animal health through the regulation of medicines ‘medical devices and bealtheare products’ The objective of the HPRA is to easure in so fr as possible, consistent with cureat medical and scientific knowledge, the quality, safety and efficacy of medicines availabe in Lland and to participate in sytems designed to do that throughout the European Union. Bebe a ‘medicine canbe authorised for use, an aplication mast be made to the HPRA and ths must ‘contain al ofthe necesarydaia supporting its quality, safety and efficacy. ‘and sationallegisationreising to Blood and Blood Componens and also for Tisaus de Cells, “Members of staff ofthe HPRA together with the assistance ofthe Board's commities and individual experts review the scientific aspects of the application and each conclusion on the likely balance ofeny benefits versus sk ofa medicine before aniving at adevsion Following approval anduse of a medicine, the HPRA monitors the type and equency of any "reported side-effects. Its vital that healtiare professional report suspected adverse fects and quality defects, since cis forms an important pat of the HPRA's ole. a adton thee {sa responsitlty on the holders of product authorizations to keep the HPRA informed of ‘events with potential suety consequences for their products, ‘The HPRA also monitos the quality of medicines by conducting inspections atsites of ‘manufacture and distribution of meicines and by random sapling of produs bh re and post authorisation. The use of medicines for clinical research purposes also fils within the PRUs remit. tn the cise of veterinary medicines thee must likewise be assurance of Gee em medical device! covers al produts, except medisins, sed in bealinear for he lagneis, prevention, monitoring or treatment of lines or das ‘The HPRA is responsible forthe regulation of medical devices onthe Lish market. The range of preducts is very wide, Includes contact lenses and encom hear valves wei ods rsuscitstors and radothenpy machines; surge asruments and syringes, ‘eters and walking frames or other assistive schnology prods preguncy ean Eine cose monitors and pacemakers ~ many thousand of emssed enchant erey dey by heatheare providers and patents, Metical devices donot include ambulasc vehicles, general worsinp equipment suchas ower or machine ols, or general purpose laboratory equipmert. Peflled devices for ramp, dg intles syringe and ceraa othe drug/ device crbinatons ae cara as medicines, not medical devices, ‘There ae thes types of medical devices outined in he legislation, They ares lows: + General medical devices Active implantable medical devices + Invitro diagnostic medical device [Teles devices are divided into classes dependent on sk which an be low, medium and high risk, ‘The principle legislation covering medical devices is: passive SORSS/EEC eonceming Active Inplanable Medic Devices (AIMDD) 1 Direstive 9342/BEC conceming General Medical Devices (NDD) * Directive 9/797EC concerning in-iro Diaguatc Medel Devices (VD) ‘The above Directives have been ranspsed into national law, a fllevs Hayle: 25 of 1996, Eucopean Communities (Active inpanble Modi Devies) Regulations, 1994 that became mandatory on Ist January 1995 + SLNo.252 of 1904, ie vices R bec 14th June 1998, 7 Reh, of002, European Communies (nvr Digna Medel Devies) Regulations, 200 tat became mandatary on he Tit Decree 0S Aznumber of key guidance notes have been prepared oasis the medal device seco on the fe ofthe Directives and relied Regulaons. in aon a number ofapptcaton mes ars been prepared to ensure that ll data required by the HPRA is inclded wth orespondence. These documents can be found onthe publican ston ofthe ‘ebsite, These forms can also be obtained inte European Commission Guideline ona Medical Device Vigilance System Medev 212-1 rev 6 REFERENCE; Decontamination standards and recommended practices {or Reusable Invasive Medical Devices (RIMID) in Acute Hospitals (2007) and subsequently HSE Standards and Recommended Practices for Dental CDU (2011) 3. Devices Directive (93/42/EEC) ‘34 Medical Devices Directives ‘There are three Medical Device Directives, covesing Active Implantable Medial Devices (90/385/EEC) to tn Vitro Dingnostic Medical Devices (98/79/EEC). Medical Devices ‘in general are covered by the European Directive 93/42/EC which came into free on ‘4th June 1993, and as amended by Dizesive 2007/47/EC which eae into force on 21 March 2010. This Directive was transposed into Irish law by he European (Communities (Medical Devices) Regulations Statutory Instrument 1994 No. 252 and ‘he European Communities (Medical devices) Amendment) Regulations 2001 No, 444 ‘snd 2002 No. 575 andthe European Communities (Medical devices) (Amendmeet) Regulations 2009 No.110, ‘The Medical Desioes Directive (934/EEC) applies to manufrs placing medical vices on the make. In doing so, it specifies the essential requirements to be met by any medical device. ‘These cseatial requirements shouldbe regard asthe minum seceptable Standard ‘Whether or nt te decontamination unit qualifies asa ‘manufacturer’ within the terms of the Dirsetive, ‘A Medical Deviet is defined in the Metical Device Directive (9342EEC) (2007/47/EC) as “an instrument, appara, appliance, software, material or ober ‘tile, whether wed alone or in combination, including the covariate by ts ‘A device which, in whole or in pat, penetrates inside the body, ithe through a body vite o though he sure ofthe body A body ores i defined as any natural opening in the body, aswell athe external surface ofthe eyeball or any permanent aril! opening such ea toma. ‘The Directive alaodstingises a surgically invasive device san invasive device which ener inside the body trough the urfice ofthe bay, withthe ed orn tha context ofa surgical operation Fr the purposes of this Dietive devices oer han ‘hose refered in in the previous subparagraph and which roducepeatntion oer ‘han hough an xtalished body oc, are rested as sural invasive device, 32 Essential requirements ofthe Medical Devices Directive (93/8/EEC) ‘The Metical Devices Dizetve (23/4/EEC) specifies the minimum Standards (sential quirement) in relation to decontamination of medial devices the sven quirement ofthis Dictve which are of partcalr relevance to stele Product include: * That eves end manuscturing processes be designed to eliminate or ede ax far as posible the isk of neton tothe patent, we nd third pts (Anne 1, paragraph 8.1), Packed in « nonreusable pack and/or according to appropiate procedures to ‘nsure that they are sterile when placed on the market and remain stele, under the storage and transport conditions lid down. + Devices should remain sterile unles the protective pckaging is damaged or pene, (Annex paragraph 8.3) + That devioes delivered ina sere state mast have been manufactured and tse by an eprops, validated method (Anne I pargrph 84). oes ot const placing gods on the matkt. However, there shouldnt be one Sandan for industry to meet and diferent ower Standerdforhealhem faciiten ‘scrdingy aliough ative onderakea solely within legal entity ae st coved by the regulations, the Hea Service Executive requis all eprocesing uit to mt the esseatal requirements of the Diective 135 Partienlar procedure for systems and procedure packs and Procedures {or sterilsation—Article 12 The decontamination of RIMD in cet decontamination uit slo nvrcly ‘suis the assembly of devices into so pac intended fore pei purpose, Te Provisions of Artile 12 ofthe Medical Devie Directive apply o these reunstgce, ‘This includes he requirement hate syste or procedure pac nds up of deviea ‘ering the CE marking sal ot bear national CE mavking. Artic 12 provides xemption from a numberof the requlstions ssseasneat requirement but not from te scot reurements It imposes olignion onthe manutice to declare: * That he ha confirmed mutual comply ofthe devices in acordance wit the ‘sonufictrersinstction, and has indicted thatthe device have been ‘rocessed together in acordance with he manufictures instructions, * That has packaged the system or procedure pack and supplied relevant information ower incorporating relevant insuctions fom te mamifictuen, * That propriate methods of neal conols nd inspection have been pli ‘Atle 12 also requires thi pay assesment ofthe stelisaton proces forsee tesks. This is undertaken by a notifed toy registered with competent athedty ‘toh forthe Republi of land isthe Hels Produ Regulsoy Autry (PRA) 3.6CE marking CE stands for: La ConformitéEuopeéae or European Conformity. The CE masks ‘ota marking conformity toa Stand but aera mackindcatngconfority to the legal requirements of European Union (BU) Directives. When «product has the legibly ofthe CE marking ino thereby reduced. +The CE marking should be fixed bythe manufacturer ort agent within te commusity. +The CE marking shoud be afixe tthe ead ofthe production contol phase, Figure: CE symbol 3.7 Notified Body ‘ANotied Body isthe organisation whic checks whee the spropiat confomity ssessment procedures forthe particular device have been followed, tis certieation oraanistion, whch he Competent Authority, of Member Stat designates to carry out ‘ne or more ofthe conformity assesment procedures dessin the annexes of the legsliton fa leland the ish Mic has desimated th Nat tv of land (NSA to ct 5 Notified Bad sical devia letislation. There re more han 60 such bois designated by Member Sits in the ‘European Union (EU) and a manufacturer eaa choose to work with any one ofthese 4. Spaulding classification 411 Classification of infection risk allure to adequately decontamiate RIMD wil increase the rskofwansnission of =toss-infton beeen patients, fecivedecntaminsionof RIMD i neces to ‘naintain the fuetionality of RIMD, mainsin integrity of biopsy specimens and protect 5. Life eycte for reusable invasive medical devices ‘5.1 Introduction ‘The decontamination fe eyele highligh the extent to which decontamination effects ‘he whole organisation and not just areas processing RIMD. Figure 5-1 highlights each stage ofthe decontamination process through which RIMD must pass prior o every we. ffctvedecootanination requires the stinment of sccplable Standards a al stages ofthe ie eye. Faure at any tage ay resul in inadequate decontamination, Figure 1: Decomamiaation lifecycle Foektes Enuomert Management Pliis/Procedures nee Hf ~ : REFERENCE; IRL: FDA(US)/IMB (IRE) /UK: ——pzAwmmhra.gov. uk! ‘The Medicines and Healthcare products Regulatory Agency (MERA) isthe government ‘gency which is responsible for ensuring that medicines aa medical devices work, an ae acceptably safe. The MHRA is an executive agency ofthe Deparment of Health “MHTRA provides a wide rnge of general advice on the requirements ofthe Medical Devices Directives in their Directive Bulletins. [MBA also provides more detailed guidance onthe proces that manfaturers should follow’ ‘meet the requirements of Medical Devices Directives in heir Guidance Notsseod Fer. Medical Devices Directive Directive 93/42/EEC covers the placing onthe market and puting into secvice of Nedioal Devices. Reovers an extemely wide range of prodvcs, inctuing, for example + Grotaid bandages + tongue depresors hip prostheses Cray equipment Eco heart valves spectacles dental xaterals ‘A copy ofthe directive (external link) can be found on the Europa website. ‘A numberof additional Directives amending the orginal Dicective ave since been introduced: + iestives 2000700 (extra Hn) and 2001/1045 (xtra ink) which brut ‘medical devices incorporating stable blood derivatives within the sope ofthe general directive, + Directive 2003/12/EC (external lnk) which reclasited breast implants into Clas I + Directive 2003/32EC (external link) which lnys dow detailed speificaions ‘elation tora of ransmiting transmissible spongfinmencephalopaties (TSE) ‘wader normal conditions of use to patients or other, va medial devices ‘manufactured wilising animal issue whichis rendevelnon-varible or aon-viable products derived from animal tissue. + Directive 2008/50 (external lnk) which reclassfes total hip, knee and shoulder Joints into Cass. +» Directive 2007/47/EC (extemal link) which doesn’t come fly into force util 21 ‘March 2010 but will amend the Medical Devices and Active lmpleutabie Medical Deviees Directives following a review of te existing provisions bythe European Commission and member states. aterence; JDI(IRE)/WEHSS(EU) http: //id.wthss.com/ Irish Decontamination Insitute Teton Assocation of tte Sanicas Mansoor was eatsbethedin 180 ad changed nano Hs Srantnnaon rt Sony 3 a _sorcertni oe Seard fh We Fount Hama Sate Senay (HFSS) st Wee Pert, ‘ed was uncngmemonrof he ES, http://www. wfhss.com/ FHSS Recommendation, Validation of Decontamination Processes ata tom a ragcenento havea quay este, vaio faction pense do mersoned ‘880 stor pac of any sneabireen The 60.2 daton coaster “Dezurated precede fr csr. recy endypreng be eu ote fetish et proce ‘i catanty ye pret omen wi reo spect A surla lsparh atoning issaton Gualeson (Prces fot and documenting Sc terrain re aera eet, ing ud caiman eicarca Male eles opieron ees [Redatamined rts when used aceatacn wan tacar owaterl pce ee eee ‘lesson wofe at el tocol oa relma physel pranetae rseey sarees as toc acum stag sod aly Bowe ck "Net: inh ever ef ananconorrance say igs cha decznlainton ces, ek sseeeent ust be ‘conduct ensuring eon esau rer exolsed endeared mmeany, zzrniehan conduing bis trough a chante relat ae \aidoton makes it soasbe turd “aration scent: Tissaenltwe want nasi, contamina us ane. Oy valor, docoamnaion may pl tsa is haeeceak fs profucion but also evncs tend petca Bese vation rei caltraan of messing doves remains roost god menacing pracen ‘Ths WSS stony reconmends its pied vleatonof ecaraninain poctssin ciation sha gu auf uty system. nan ate prrclan se pled sl gomanes eaae oe oe {ter pepose ad are anaa pant ne W485 Escalon Warking Group to remove or minimise the rik of incon or other bazar, 26.2.Seope ‘The objective of this procedure isto provide guideline in relation to the transfer of ‘IMD to third pares forte inspection, service, epi, or disposal of RIMD, 2633 Contents Section One: General principles 264 Prooedare Seotion One: General prnsples {All RIMD intended for inspection sevice, epi o disor must be decontaminetd befor desptch and must be accompanied by acetate stating the method by which hey were decoataminsted. (All RIMD must be decontaminsted in acordance with the manuficures" instructions. 3 items are aispatched to supp, prseated fo sevice or inspection oa ‘hospital premises without declantion of contaminstio statis and without por sgreement, he recipient may ese to handle such ites ut they have been (uk) S0NA/ MISH SOCIETY OF ENDOSCOPY NURSES / INFECTION CONTROL NURSES ASSOCTION Re/UK) USE.NF/ —BATISH PHARMACOPOEIA British Pharmacopoeia 2042, the only official source of British pharmaceutical standards ‘The Bish Phamacopcia (BP) 2012 isthe lading eollesion of stad for UK medicinal Products and pharmaceutical substances. Produced by the Bish Pharmacopoda, Commission Secretariat of the Medicines nd Healare products Regulatory Agency, the Development of standais and regulations the lish conti ‘Repo AS80200 Following concems raised by the Members ofthe lsh Association of Stele Service ‘Maragers CASSM in elation tothe rss associated within decontamination processes, the XASSM, in 203, condacted national suvey on eprocesing of RIMD practising ‘antl decontamination nits (COU). A report ofthe fins na set Dr Mary Hye, ‘Assistant Dizetor with responsiblity for Quality, Risk and Customer Cae in the Noten Hospitals Ofice(NHO) who then se up a tering Commit provide guidance on

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